Brazilian Health Surveillance Agency (ANVISA) 
www.anvisa.gov.br 
 
Public Consultation No 47 of 25 August 2008. D.O.U. (Official State Gazette) of 26.8.2008 
The Board of the National Health Surveillance Agency , in the exercise of the powers granted by 
Item IV of Article 11 and Artic le 35 of ANVISA’s Regulati ons, approved by Decree No. 3029 of 
16 April 1999, and having regard to the provisions of  Item V and points 1 and 3 of Article 54 of the 
Internal Regulations approved in accordance w ith Appendix I of ANVISA Administrative Ruling 
No. 354 of 11 August 2006, republished in the DOU of 21 August 2006, at a meeting held on 
19 August 2008, 
Article 1 - A period of 30 (thirty) days from the da te of publication of this  Public Consultation is 
hereby declared open for presenting criticism a nd suggestions concerning the proposed Regulatory 
Instruction laying down speci fic criteria for grouping ORTHOPAEDIC IMPLANTS  into families 
and systems for registers, in the Annex. 
Art. 2. The full text of the proposed  Regulatory Instruction referred to  in the previous Article will 
be available, during the c onsultation period, at the follo wing website http://www.anvisa.gov.br
, and 
suggestions should be sent in writing to the fo llowing address: Agência Nacional de Vigilância 
Sanitária, Gerência-Geral de Tecnologia de Prod utos para Saúde, SEPN 515, Bloco B, Ed. Ômega, 
Asa Norte, Brasília, DF, CEP 70.770-502, Br azil, or Fax: (061) 3448-1058 or e-mail: 
tecnologia.produtos@anvisa.gov.br  with the subject entered as “ Requisitos Específicos para 
agrupamento em famílias e sistemas de IMPLA NTES ORTOPÉDICOS para fins de registro ” 
(Specific criteria for grouping ORTHOPAEDI C IMPLANTS into families and systems for 
registers). 
Art. 3. At the end of the period specified in Art.  1, the National Health Su rveillance Agency will 
talk to the Bodies and Entities involved and other parties with an interest in the matter, and ask 
them to nominate representatives for subsequent discussions, in orde r to arrive at a final wording. 
DIRCEU RAPOSO DE MELLO   
REGULATORY INSTRUCTION No laying down specific criteria for grouping ORTH OPAEDIC IMPLANTS into families and systems 
for registers. 
  The Director-President of the Nati onal Health Surveillance Agency , in the exercise of the 
powers granted by the Presidential Decree of 4 January 2008 appointi ng him and Item X of Article 
13 of ANVISA’s Regulations, approved by Decr ee No 3029 of 16 April 1999, and having regard to 
the provisions of Item VIII of Article 16 and Item II, paragraph 2 of Article 55 of the Internal Regulations approved in accordance with Appendix I of ANVISA Administra tive Ruling No 354 of 
11 August 2006, republished in the DOU of 21 August 2006, 
Whereas the sole paragraph of Article 1 of Resoluti on of the Board No 59 of 25 August 2008 , 
established the technical regula tion containing the general requi rements for grouping orthopaedic 
implants into families and systems for registers; 
Whereas there is a need to establish specific criteria to guide the preparation of procedures for 
registering products classified as  orthopaedic implants with the aim of enabling risk convergence 
for such products, resolves: 
Article 1 The specific criteria for grouping orthopaedic implants into families and systems for 
registers contained in the Annex to th is Regulatory Instruction are approved. 
Article 2 All criteria app licable to replacement implants for hip, knee, shoulder, elbow, ankle, 
wrist and temporomandibular joints. 
Article 3 All criteria applicable to implants for osteosynthesis: plates, screws, clips, flexible 
wires and flexible cables, pins a nd rigid wires, intramedullary nails , anchors for attaching soft tissue 
to bone, graft bearing diaphyseal spacers, implanta ble mandibular braces, calva rial fixation devices, 
halo braces and spinal implants ha ve been taken into consideration. 
Article 4 This Regulation sh all enter into force on th e date of its publication. 
DIRCEU RAPOSO DE MELLO 
  
ANNEX I 
SPECIFIC CRITERIA FOR GROUPING JOINT RE PLACEMENT IMPLANTS INTO FAMILIES 
AND SYSTEMS FOR REGISTERS 
PART 1 – HIP JOINT 1.1 The following criteria apply to specific pa rts for grouping hip join t replacements into 
families and systems for registers: 
CRITERIA COMPONENTS 
Material All components. 
Composition (monolithic/composite) Acetabulum 
Method of fixation (cemented/cementless) - Pin 
- Acetabulum 
Modularity - Head/pin 
- Acetabular nucleus/capsule Functionality (with or without compensation for 
loss of extrinsic stabilisation of the joint)* Acetabular nucleus 
Range of intracomponent motion – centrality of 
joint (monopolar/bipolar)* Femur head 
 
*Specific criteria. 1.2 In addition to the criteria specified in the pr evious item, the following specific criteria apply 
to hip joint replacement systems:  
SPECIFICATION CRITERIA APPL ICABLE TO THE SYSTEM 
Scope of implant – with or without acetabular 
arthroplasty. - Partial 
- Total 
Extent of interference with the epiphysis - Full 
- Surface 
Extent of compartmentalisation of the system Unicompartmental only 
Joint containment structure Anatomical only 
 
1.3 Implants with resurfacing treatments aggreg ating raw materials which differ from those of 
their production are to be grouped in a different  register from implants without resurfacing 
treatment of this kind. 
1.4 Composite acetabular nuclei containing various materials (met als, polymers, ceramics and 
polymer-ceramics) need to be cl assed in different registers. 
1.5 Description of possible hip joint replacement systems: 
a) Total arthroplasty  
a.1) Non-modular systems for to tal arthroplasties – cemented: 
a.1.1 Non-modular systems for total arthroplas ties – cemented, with monolithic acetabulum: 
a.1.2 Non-modular systems for total arthroplasties – cemented, with composite acetabulum: a.2) Modular systems for total arthroplasties: a.2.1 Modular systems for total arthroplasties with  a modular, cemented pin, ceramic head with 
monolithic acetabulum: 
a.2.2 Modular systems for total arthroplasties with a modular, cemented pin, ceramic head, 
composite acetabulum and cemented capsule; 
a.2.3 Modular systems for total arthroplasties with a modular, cemented pin, ceramic head, 
composite acetabulum and cementless capsule; 
a.2.4 Modular systems for total arthroplasties with  a modular, cemented pin, metallic head with 
monolithic acetabulum: 
a.2.5 Modular systems for total arthroplasties w ith a modular, cemented pin, metallic head, 
composite acetabulum and cemented capsule; 
a.2.6 Modular systems for total arthroplasties w ith a modular, cemented pin, metallic head, 
composite acetabulum and cementless capsule; a.2.7 Modular systems for total arthroplasties with a modular, cementless pin, ceramic head with 
monolithic acetabulum: 
a.2.8 Modular systems for total arthroplasties with a modular, cementless pin, ceramic head, 
composite acetabulum and cemented capsule; 
a.2.9 Modular systems for total arthroplasties with a modular, cementless pin, ceramic head, 
composite acetabulum and cementless capsule; 
a.2.10 Modular systems for total arthroplasties with  a modular, cementless pin, metallic head with 
monolithic acetabulum: 
a.2.11 Modular systems for total arthroplasties w ith a modular, cementless pin, metallic head, 
composite acetabulum and cemented capsule; 
a.2.12 Modular systems for total arthroplasties w ith a modular, cementless pin, metallic head, 
composite acetabulum and cementless capsule; 
b) Partial arthroplasty  
b.1) Non-modular part ial arthroplasty 
b.1.1 – Thompson arthroplasty – cemented. b.2) Modular, cemented partial arthroplasty systems b.2.1 – modular metal pin, metallic head. b.2.2 – modular metal pin, ceramic head. 
b.3) Modular, cemented bipolar partial arthroplasty systems 
b.3.1 – modular metal pin, metal head and bipolar component. b.3.2 – modular metal pin, ceramic head and bipolar component. b.3.2 – non-modular metal pin and bipolar co mponent. (modularity ensured by a bipolar 
component) 
c) Resurfacing arthroplasty
 
c.1) Systems for resurfacing total arthroplasties: c.1.1 – System for resurfacing the femur with a cemented acetabulum. c.1.2 – System for resurfacing the fe mur with a cementless acetabulum. 
1.6 Description of possible families of  hip joint replacement components: 
d) Total arthroplasty
 
d.1 Family of non-modular pins d.2 Family of modular pins – cemented d.3 Family of modular pins – cementless d.4 Head family – ceramic  d.5 Head family – metallic  d.6 Family of bipolar adaptation mechanism d.7 Family of monolithic polymer acetabula, cemented d.8 Family of ceramic acetab ular nuclei (cementless) 
d.9 Family of metallic ace tabular nuclei (cementless) d.10 Family of unrestricted polymer acetabular nuclei (cementless) 
d.11 Family of partially restricted polymer acetabular nuclei (cementless) 
d.12 Family of polymer acetabular nuclei with metallic joint surface (cementless) 
d.13 Family of polymer acetabular nuclei with ceramic joint surface (cementless) 
d.14 Family of acetabular capsules, cemented (metal) d.15 Family of acetabular capsules, cementless (metal) e) Resurfacing arthroplasty
 
e.1 Head family (consider the general criterion – material). e.2 Family of monolithic metal acetabula, cemented. e.3 Family of monolithic metal acetabula, cementless. 1.7 Description of possible accessories for fa milies of implantable hip joint replacement 
components and systems: 
1.7.1 Acetabulum accessories (where applicable to the product): screws, wedges, meshes and 
acetabular reinforcements. 
PART 2 – KNEE JOINT 2.1 The following criteria apply to specific parts for grouping knee joint replacements into 
families and systems for registers: 
1.7.2 Pin accessories (where applicable to the produc t): centralisers, cement restrictors, wedges 
and meshes. 
CRITERIA COMPONENTS 
Material All components 
Composition (monolithic/composite) Tibial component 
Method of fixation (cemented/cem entless) - Femoral component 
- Tibial component 
Modularity Tibial component 
Range of motion (fixed or mobile)* Tibia platform 
* Specific criterion. 
2.2 In addition to the criteria specified in the pr evious item, the following specific criteria apply 
to knee joint replacement systems: 
CRITERIA APPLICABLE TO TH E SYSTEM SPECIFICATION 
Functionality (structural restrictions) - Restricted 
- Partially restricted - Unrestricted 
Scope of implant - Partial 
- Total 
Extent of interference with the epiphysis Surface only 
Extent of compartmentalisation of the system - Femoropatellar 
- Femorotibial - Multicompartmental Joint containment structure Anatomical only 
2.3 Description of possible knee joint replacement systems: 
a) Femorotibial unicompartmental total arthroplasty:  
a.1 Femorotibial unicompartmental total arthropl asty system with metal femoral component, 
fixed bearing and cemented tibia platform; 
a.2 Femorotibial unicompartmental total arthropl asty system with metal femoral component, 
fixed bearing and cemen tless tibia platform; 
a.3 Femorotibial unicompartmental total arthropl asty system with metal femoral component, 
mobile bearing and cemented tibia platform; 
a.4 Femorotibial unicompartmental total arthropl asty system with metal femoral component, 
mobile bearing and cementless tibia platform; 
a.5 Femorotibial unicompartmental total arthropl asty system with ceramic femoral component, 
fixed bearing and cemented tibia platform; 
a.6 Femorotibial unicompartmental total arthropl asty system with ceramic femoral component, 
fixed bearing and cemen tless tibia platform; 
a.7 Femorotibial unicompartmental total arthropl asty system with ceramic femoral component, 
mobile bearing and cemented tibia platform; 
a.8 Femorotibial unicompartmental total arthropl asty system with ceramic femoral component, 
mobile bearing and cementless tibia platform; 
b) Femoropatellar unicompart mental total arthroplasty:  
b.1 Femoropatellar unicompartmental total arthro plasty system with metal femoral component, 
and cemented, monolithic patellar component; 
b.2 Femoropatellar unicompartmental total arthro plasty system with metal femoral component, 
and cemented, composite patellar component; 
b.3 Femoropatellar unicompartmental total arthro plasty system with metal femoral component, 
and cementless, monolithic patellar component; 
b.4 Femoropatellar unicompartmental total arthro plasty system with metal femoral component, 
and cementless, composite patellar component; 
b.5 Femoropatellar unicompartmental total ar throplasty system with ceramic femoral 
component, and cemented, mono lithic patellar component; 
b.6 Femoropatellar unicompartmental total ar throplasty system with ceramic femoral 
component, and cemented, composite patellar component; 
b.7 Femoropatellar unicompartmental total ar throplasty system with ceramic femoral 
component, and cementless, monolithic patellar component; 
b.8 Femoropatellar unicompartmental total ar throplasty system with ceramic femoral 
component, and cementless, composite patellar component; 
c) Total multicompartmental arthroplasty  
c.1 Total multicompartmental arthroplasty w ith metal femoral component and non-modular 
tibial component: 
c.1.1 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, monolithic tibial component and cemented monolithic patellar component;  c.1.2 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, monolithic tibial component and cemented composite patellar component; 
c.1.3 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, monolithic tibial component and cementless composite patellar component;  
c.1.4 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, composite tibial component a nd cemented monolithic patellar component; 
c.1.5 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, composite tibial component a nd cemented composite patellar component; 
c.1.6 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, composite tibial component a nd cementless composite patellar component; 
c.1.7 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, monolithic tibial component and cemented monolithic patellar component;  
c.1.8 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, monolithic tibial component and cemented composite patellar component; 
c.1.9 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, monolithic tibial component and cementless composite patellar component;  
c.1.10 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, composite tibial component a nd cemented monolithic patellar component; 
c.1.11 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, composite tibial component a nd cemented composite patellar component; 
c.1.12 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, composite tibial component a nd cementless composite patellar component; 
c.1.13 Multicompartmental total arthroplasty system, restricted, with cementless femoral 
component, monolithic tibial component a nd cemented monolithic patellar component; 
c.1.14 Multicompartmental total arthroplasty system, restricted, with cementless femoral 
component, monolithic tibial component and cemented composite patellar component; 
c.1.15 Multicompartmental total arthroplasty system, restricted, with cementless femoral 
component, monolithic tibial component a nd cementless composite patellar component; 
c.1.16 Multicompartmental total arthroplasty system, restricted, with cementless femoral 
component, composite tibial component a nd cemented monolithic patellar component; 
c.1.17 Multicompartmental total arthroplasty system, restricted, with cementless femoral 
component, composite tibial component a nd cemented composite patellar component; 
c.1.18 Multicompartmental total arthroplasty system, restricted, with cementless femoral 
component, composite tibial component a nd cementless composite patellar component; 
c.1.19 Multicompartmental total arthroplasty sy stem, unrestricted, with cementless femoral 
component, monolithic tibial component a nd cemented monolithic patellar component; 
c.1.20 Multicompartmental total arthroplasty sy stem, unrestricted, with cementless femoral 
component, monolithic tibial component and cemented composite patellar component; 
c.1.21 Multicompartmental total arthroplasty sy stem, unrestricted, with cementless femoral 
component, monolithic tibial component a nd cementless composite patellar component; 
c.1.22 Multicompartmental total arthroplasty sy stem, unrestricted, with cementless femoral 
component, composite tibial component a nd cemented monolithic patellar component; c.1.23 Multicompartmental total arthroplasty sy stem, unrestricted, with cementless femoral 
component, composite tibial component a nd cemented composite patellar component; 
c.1.24 Multicompartmental total arthroplasty sy stem, unrestricted, with cementless femoral 
component, composite tibial component a nd cementless composite patellar component; 
c.2 Total multicompartmental arthroplasty w ith ceramic femoral component and non-modular 
tibial component: 
c.2.1 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, monolithic tibial component a nd cemented monolithic patellar component; 
c.2.2 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, monolithic tibial component and cemented composite patellar component; 
c.2.3 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, monolithic tibial component and cemented composite patellar component; 
c.2.4 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, composite tibial component a nd cemented monolithic patellar component; 
c.2.5 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, composite tibial component a nd cemented composite patellar component; 
c.2.6 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, composite tibial component a nd cementless composite patellar component; 
c.3 Multicompartmental total arthroplasty w ith metal femoral component, modular tibial 
component (tibia platform and bearing) and taking into consideration only cemented monolithic patellar components: 
c.3.1 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, fixed bearing, cemented tibia platform  and cemented monolithic patellar component; 
c.3.2 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, fixed bearing, cemented tibia platform  and cemented composite patellar component; 
c.3.3 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, fixed bearing, cemented tibia platfo rm and cementless composite patellar component; 
c.3.4 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, fixed bearing, cementless tibia platform  and cemented monolithic patellar component; 
c.3.5 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, fixed bearing, cementless tibia platform  and cemented composite patellar component; 
c.3.6 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, fixed bearing, cementless tibia platform  and cementless composite patellar component; 
c.3.7 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, fixed bearing, cemented tibia platform  and cemented monolithic patellar component; 
c.3.8 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, fixed bearing, cemented tibia platform  and cemented composite patellar component; 
c.3.9 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, fixed bearing, cemented tibia platfo rm and cementless composite patellar component; 
c.3.10 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, fixed bearing, cementless tibia platform  and cemented monolithic patellar component; 
c.3.11 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, fixed bearing, cementless tibia platform  and cemented composite patellar component; c.3.12 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, fixed bearing, cementless tibia platform  and cementless composite patellar component; 
c.3.13 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, mobile bearing, cemented tibia platform  and cemented monolithic patellar component; 
c.3.14 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, mobile bearing, cemented tibia platfo rm and cemented composite patellar component; 
c.3.15 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, mobile bearing, cemented tibia platform  and cementless composite patellar component; 
c.3.16 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, mobile bearing, cementless tibia platfo rm and cemented monolithic patellar component; 
c.3.17 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, mobile bearing, cementle ss tibia platform and cemented composite patellar component; 
c.3.18 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, mobile bearing, cem entless tibia platform and cementless composite patellar 
component; 
c.3.19 Multicompartmental total arthroplasty system, restricted, with cementless femoral 
component, fixed bearing, cemented tibia platform  and cemented monolithic patellar component; 
c.3.20 Multicompartmental total arthroplasty system, restricted, with cementless femoral 
component, fixed bearing, cemented tibia platform  and cemented composite patellar component; 
c.3.21 Multicompartmental total arthroplasty system, restricted, with cementless femoral 
component, fixed bearing, cemented tibia platfo rm and cementless composite patellar component; 
c.3.22 Multicompartmental total arthroplasty system, restricted, with cementless femoral 
component, fixed bearing, cementless tibia platform  and cemented monolithic patellar component; 
c.3.23 Multicompartmental total arthroplasty system, restricted, with cementless femoral 
component, fixed bearing, cementless tibia platform  and cemented composite patellar component; 
c.3.24 Multicompartmental total arthroplasty system, restricted, with cementless femoral 
component, fixed bearing, cementless tibia platform  and cementless composite patellar component; 
c.3.25 Multicompartmental total arthroplasty sy stem, unrestricted, with cementless femoral 
component, fixed bearing, cemented tibia platform  and cemented monolithic patellar component; 
c.3.26 Multicompartmental total arthroplasty sy stem, unrestricted, with cementless femoral 
component, fixed bearing, cemented tibia platform  and cemented composite patellar component; 
c.3.27 Multicompartmental total arthroplasty sy stem, unrestricted, with cementless femoral 
component, fixed bearing, cemented tibia platfo rm and cementless composite patellar component; 
c.3.28 Multicompartmental total arthroplasty sy stem, unrestricted, with cementless femoral 
component, fixed bearing, cementless tibia platform  and cemented monolithic patellar component; 
c.3.29 Multicompartmental total arthroplasty sy stem, unrestricted, with cementless femoral 
component, fixed bearing, cementless tibia platform  and cemented composite patellar component; 
c.3.30 Multicompartmental total arthroplasty sy stem, unrestricted, with cementless femoral 
component, fixed bearing, cementless tibia platform  and cementless composite patellar component; 
c.3.31 Multicompartmental total arthroplasty sy stem, unrestricted, with cementless femoral 
component, mobile bearing, cemented tibia platform  and cemented monolithic patellar component; 
c.3.32 Multicompartmental total arthroplasty sy stem, unrestricted, with cementless femoral 
component, mobile bearing, cemented tibia platfo rm and cemented composite patellar component; c.3.33 Multicompartmental total arthroplasty sy stem, unrestricted, with cementless femoral 
component, mobile bearing, cemented tibia platform  and cementless composite patellar component; 
c.3.34 Multicompartmental total arthroplasty sy stem, unrestricted, with cementless femoral 
component, mobile bearing, cementless tibia platfo rm and cemented monolithic patellar component; 
c.3.35 Multicompartmental total arthroplasty sy stem, unrestricted, with cementless femoral 
component, mobile bearing, cementle ss tibia platform and cemented composite patellar component; 
c.3.36 Multicompartmental total arthroplasty sy stem, unrestricted, with cementless femoral 
component, mobile bearing, cem entless tibia platform and cementless composite patellar 
component; 
c.4 Multicompartmental total arthroplasty w ith ceramic femoral component, modular tibial 
component (tibia platform and fixed bearing) and taking into consider ation only unrestricted 
cemented ceramic femoral components: 
c.4.1 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, fixed bearing, cemented tibia platform  and cemented monolithic patellar component; 
c.4.2 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, fixed bearing, cemented tibia platform  and cemented composite patellar component; 
c.4.3 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, fixed bearing, cemented tibia platfo rm and cementless composite patellar component; 
c.4.4 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, fixed bearing, cementless tibia platform  and cemented monolithic patellar component; 
c.4.5 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, fixed bearing, cementless tibia platform  and cemented composite patellar component; 
c.4.6 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, fixed bearing, cementless tibia platform  and cementless composite patellar component; 
c.4.7 Multicompartmental total arthroplasty sy stem, unrestricted, with cemented femoral 
component, mobile bearing, cemented tibia platform  and cemented monolithic patellar component; 
c.4.8 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, mobile bearing, cemented tibia platfo rm and cemented composite patellar component; 
c.4.9 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, mobile bearing, cemented tibia platform  and cementless composite patellar component; 
c.4.10 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, mobile bearing, cementless tibia platfo rm and cemented monolithic patellar component; 
c.4.11 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, mobile bearing, cementle ss tibia platform and cemented composite patellar component; 
c.4.12 Multicompartmental total arthroplasty system, restricted, with cemented femoral 
component, mobile bearing, cem entless tibia platform and cementless composite patellar 
component; 
2.4 Description of possible families of  knee joint replacement components:  
d) Total multicompartmental arthroplasty  
d.1 Cemented metal femoral component, restricted d.2 Cemented metal femoral component, unrestricted d.3 Cementless metal femoral component, restricted d.4 Cementless metal femoral component, unrestricted 
d.5 Cemented ceramic femoral component, unrestricted d.6 Non-modular monolithic tibial component (polymer / cemented) d.7 Non-modular composite tibial component wit hout stabiliser (polymer-metal / cemented) 
d.8 Non-modular composite tibial component w ith stabiliser (polymer-metal / cemented) 
d.9 Tibia platform, cemented (metal) d.10 Tibia platform, cementless (metal) d.11 Fixed bearing with stabiliser (polymer) 
d.12 Fixed bearing without stabiliser (polymer) 
d.13 Mobile bearing (polymer  / without stabiliser) 
d.14 Cemented monolithic polymer patella d.15 Cementless monolithic polymer patella d.16 Cemented monolithic metal patella d.17 Cementless monolithic metal patella d.18 Cemented composite patella (polymer / metal base) d.19 Cementless composite patella (polymer / metal base) 2.5 Description of possible accessories for fa milies of implantable knee joint replacement 
components and systems: 
2.5.1 Accessories for tibial component s (where applicable to the product): spacers, wedges and 
pins. 
2.5.2 Accessories for femoral components (where ap plicable to the produc t): pins and screws. 
PART 3 – SHOULDER JOINT 3.1 The following criteria apply to specific part s for grouping shoulder joint replacements into 
families and systems for registers: 
CRITERIA COMPONENTS 
Material All components 
Composition (monolithic/composite) Glenoid component 
Method of fixation (cemented/cementless) - Pin 
- Glenoid component 
Modularity (modular/not modular) Asso ciation of head – humeral stem. 
 
3.2 In addition to the criteria speci fied in the previous item, the following specific criteria apply 
to shoulder joint replacement systems: 
CRITERIA APPLICABLE TO TH E SYSTEM SPECIFICATION 
Functionality - Partial 
- Unrestricted 
Scope of implant – with or  without glenoid - Partial arthroplasty. - Total 
Extent of interference with the epiphysis - Full 
- Surface 
Range of intracomponent motion – centrality of joint - Monopolar 
- Bipolar 
Extent of compartmentalisation of the system Unicompartmental only 
Joint containment structure - Constrained standard  
- Constrained reverse 
 
3.3 Description of possible shoul der joint replacement systems: 
a) Constrained total arthroplasty:  
a.1 – constrained total arthroplasty: a.2 – constrained reverse total arthroplasty: b) Unconstrained total arthroplasty:
 
b.1 Modular systems for unconstrained partial ar throplasties (without glenoid component): 
b.1.1 – Modular systems for unconstrained modul ar partial arthropl asties, cemented; 
b.1.2 – Modular systems for unconstrained modul ar partial arthropl asties, cementless; 
b.1.3 – Modular systems for unconstrained non-m odular partial arthroplasties, cemented; 
b.1.4 – Modular systems for unconstrained non-m odular partial arthr oplasties, cementless. 
b.2 Modular systems for unconstrained total arth roplasties (without glenoid component): 
b.2.1 Modular systems for unconstrained total arthr oplasties with a modular, cemented humeral 
shaft, monolithic metal glenoid component, cemented: 
b.2.2 Modular systems for unconstrained total arthr oplasties with a modular, cemented humeral 
shaft, monolithic polymer glenoid component, cemented: 
b.2.3 Modular systems for unconstrained total arthr oplasties with a modular, cemented humeral 
shaft, composite polymer/metal glenoid component, cemented: 
b.2.4 Modular systems for unconstrained total arthr oplasties with a modular, cemented humeral 
shaft, composite polymer/metal glenoid component, cementless: 
b.2.5 Modular systems for unconstrained total arthr oplasties with a modular, cementless humeral 
shaft, monolithic metal glenoid component, cemented: 
b.2.6 Modular systems for unconstrained total arthr oplasties with a modular, cementless humeral 
shaft, monolithic polymer glenoid component, cemented: 
b.2.7 Modular systems for unconstrained total arthr oplasties with a modular, cementless humeral 
shaft, composite polymer/metal glenoid component, cementless: 
b.2.8 Modular systems for unconstrained total arthr oplasties with a modular, cementless humeral 
shaft, composite polymer/metal glenoid component, cementless. 
c) Systems for total unconstrai ned bipolar arthroplasties of  part of the epiphysis:  
c.1 – Systems for total unconstraine d bipolar arthroplasties of part of the epiphysis with a modular, 
cemented metal shaft, metal head and bipolar component; c.2 – Systems for total unconstrai ned bipolar arthroplasties of pa rt of the epiphysis with a 
cementless metal shaft, metal head and bipolar component. 
d) Unconstrained resurfacing arthroplasty:  
d.1 Total systems for resurfacing arthroplasties with a monolithic metal glenoid component, 
cemented; 
d.2 Total systems for resurfacing arthroplasties with a monolithic polymer glenoid component, 
cemented; 
d.3 Total systems for resurfacing arthroplasties  with a composite metal/polymer glenoid 
component, cemented; 
d.4 Total systems for resurfacing arthroplasties  with a composite metal/polymer glenoid 
component, cementless; 
3.4 Description of possible families of shoulder joint replacement components: 
a) Unconstrained arthroplas ty – total and resurfacing:  
a.1 Family of non-modular metal shafts, cemented; a.2 Family of non-modular metal shafts, cementless; a.3 Family of modular head less metal shafts, cemented; 
a.4 Family of modular head less metal shafts, cementless; 
a.5 Family of metal heads, cemented, for total arthroplasties; 
a.6 Family of metal heads, cement ed, for resurfacing arthroplasties; 
a.7 Family of bipolar metal/polymer adaptation mechanisms, press fit; a.8 Family of monolithic polymer  glenoid components, cemented; 
a.9 Family of monolithic metal glenoid components, cemented; a.10 Family of composite (metal/pol ymer) glenoid components, cemented; 
a.11 Family of composite (metal/polym er) glenoid components, cementless. 
b) Constrained total arthroplasty:
 
b.1 Family of metal heads for constrained arthroplasties; 
b.2 Family of composite (metal/polymer) c onstrained glenoid components, cemented. 
c) Constrained reverse total arthroplasty:  
c.1 Family of constraint devices for compos ite (metal/polymer) glenoid components; c.2
 Family of monolithic metal glenoid component s, cemented, for reverse total arthroplasty. 
3.5 Description of possible accesso ries for families of implantable shoulder joint replacement 
components and systems: screws and meshes. 
 PART 4 – ELBOW JOINT 4.1 The following criteria apply to specific pa rts for grouping elbow joint replacements into 
families and systems for registers: 
CRITERIA COMPONENTS 
Material All components Composition (monolithic/composite) Bearing 
Method of fixation (cemented/ cementless) Pin and bearing. 
Modularity (modular/not modular) Asso ciation of head – radial stem. 
4.2 In addition to the criteria speci fied in the previous item, the following specific criteria apply 
to elbow joint replacement systems: 
CRITERIA APPLICABLE TO TH E SYSTEM SPECIFICATION 
Functionality - Restricted 
- Partial - Unrestricted 
Scope of implant – with or without preservation 
of one of the radiohumeral joint surfaces. - Partial 
- Total 
Extent of interference with the epiphysis - Full 
- Surface 
Range of intracomponent motion – centrality of radiohumeral joint - Monopolar 
- Bipolar 
Extent of compartmenta lisation of the system 
(radiohumeral / humeroulnar) - Multicompartmental 
- Unicompartmental 
Joint containment structure Anatomical 
 
4.3 Description of possible elbow  joint replacement systems: 
a) Systems for unrestricted total elbow arthroplasty:  
a.1 Unrestricted total elbow ar throplasty, with cemented humeral component, cemented ulnar 
component, monolithic polymer ulnar sh aft and monopolar radial component; 
a.2 Unrestricted total elbow ar throplasty, with cemented humeral component, cemented ulnar 
component, monolithic polymer ulnar shaft and bipolar radial component; 
a.3 Unrestricted total elbow ar throplasty, with cemented humeral component, cemented ulnar 
component, composite (metal / polymer) ul nar shaft and monopolar radial component; 
a.4 Unrestricted total elbow ar throplasty, with cemented humeral component, cemented ulnar 
component, composite (metal / polymer) ul nar shaft and bipolar radial component; 
a.5 Unrestricted total elbow ar throplasty, with cemented humeral component, cementless ulnar 
component, monolithic polymer ulnar sh aft and monopolar radial component; 
a.6 Unrestricted total elbow ar throplasty, with cemented humeral component, cementless ulnar 
component, monolithic polymer ulnar shaft and bipolar radial component; 
a.7 Unrestricted total elbow ar throplasty, with cemented humeral component, cementless ulnar 
component, composite (metal / polymer) ul nar shaft and monopolar radial component; 
a.8 Unrestricted total elbow ar throplasty, with cemented humeral component, cementless ulnar 
component, composite (metal / polymer) ul nar shaft and bipolar radial component; 
a.9 Unrestricted total elbow arthroplasty, with cementless humeral component, cemented ulnar 
component, monolithic polymer ulnar sh aft and monopolar radial component; 
a.10 Unrestricted total elbow arthroplasty, with cementless humeral component, cemented ulnar 
component, monolithic polymer ulnar shaft and bipolar radial component; a.11 Unrestricted total elbow arthroplasty, with cementless humeral component, cemented ulnar 
component, composite (metal / polymer) ul nar shaft and monopolar radial component; 
a.12 Unrestricted total elbow arthroplasty, with cementless humeral component, cemented ulnar 
component, composite (metal / polymer) ul nar shaft and bipolar radial component; 
a.13 Unrestricted total elbow ar throplasty, with cementless humeral component, cementless ulnar 
component, monolithic polymer ulnar sh aft and monopolar radial component; 
a.14 Unrestricted total elbow ar throplasty, with cementless humeral component, cementless ulnar 
component, monolithic polymer ulnar shaft and bipolar radial component; 
a.15 Unrestricted total elbow ar throplasty, with cementless humeral component, cementless ulnar 
component, composite (metal / polymer) ul nar shaft and monopolar radial component; 
a.16 Unrestricted total elbow ar throplasty, with cementless humeral component, cementless ulnar 
component, composite (metal / polymer) ul nar shaft and bipolar radial component. 
4.4 Description of possible families of  elbow joint replacement components: 
a) Partial and total arthroplasty  
a.1 Metal humeral component, cemented; a.2 Metal humeral component, cementless; a.3 Metal ulnar component, cemented; a.4 Metal ulnar component, cementless; 
a.5 Polymer ulnar component, cemented; 
a.6 Composite (polymer/metal) ulnar component, cemented; a.7 Non-modular monolithic polymer radial component; a.8 Non-modular monolithic metal radial component; a.9 Non-modular composite(metal / polymer) radial component; a.10 Modular monopolar radial component; a.11 Modular bipolar radial component; a.12 Bipolar adaptation mechanism; a.13 Humeral resurfacing arthropl asty component, cemented.  
4.5 Description of possible accessories for fa milies of implantable elbow joint replacement 
components and systems: screws and reinforcement mesh for pins. 
PART 5 – ANKLE JOINT 5.1 The following criteria apply to specific part s for grouping ankle joint replacements, i.e. the 
tibia-talus and fibular-malleolar interface, into families and systems for registers: 
CRITERIA COMPONENTS 
Material All components 
Method of fixation (cemented/ cementless) - Tibia platform 
- Talar component 
 
5.2 In addition to the criteria specified in the pr evious item, the following specific criteria apply 
to ankle joint replacement systems: CRITERIA APPLICABLE TO TH E SYSTEM* SPECIFICATION 
Composition - Monolithic 
- Composite 
Functionality Partial 
Modularity Modular 
Scope of implant Total 
Extent of interference with the epiphysis Full 
Range of intracomponent motion Fixed 
Extent of compartmentalisation of  the system Unicompartmental 
Joint containment structure Anatomical 
5.3 Description of possible ankl e joint replacement systems: 
5.3.1 System for ankle arthroplasty with cemented  tibia platform and cemented talar component; 
5.3.2 System for ankle arthroplasty with cemented  tibia platform and cementless talar component; 
5.3.3 System for ankle arthroplasty with cementle ss tibia platform and cemented talar component; 
5.3.4 System for ankle arthroplasty with ce mentless tibia platform and cementless talar 
component; 
5.4 Description of possible families of  ankle joint replacement components: 
5.4.1 Family of metal tibia platforms, cemented. 5.4.2 Family of metal tibia platforms, cementless. 
5.4.3 Family of polymer joint bearings; 5.4.4 Family of metal talar components, cementless; 5.4.5 Family of metal talar components, cemented. PART 6 – WRIST JOINT 6.1 The following criteria apply to specific pa rts for grouping wrist joint replacements into 
families and systems for registers: 
CRITERIA COMPONENTS 
Material All components 
Modularity - Radial component 
- Carpal component 
Method of fixation (cemented/cem entless) - Radial component 
- Carpal component 
 
6.2 In addition to the criteria specified in the pr evious item, the following specific criteria apply 
to wrist joint replacement systems: 
CRITERIA APPLICABLE TO TH E SYSTEM* SPECIFICATION 
Composition Monolithic 
Functionality Partial Scope of implant Total 
Extent of interference with the epiphysis Full 
Range of intracomponent motion Fixed 
Extent of compartmentalisat ion of the system - Unicompartmental radiocarpal 
- Unicompartmental radiocarpal and distal radioulnar 
Joint containment structure Anatomical 
 
6.3 Description of possible wris t joint replacement systems: 
6.3.1 Unicompartmental system with radial join t bearing, modular cemented radial component 
and non-modular cemented carpal component; 
6.3.2 Unicompartmental system with radial join t bearing, modular cemented radial component 
and non-modular cementless carpal component; 
6.3.3 Unicompartmental system with radial join t bearing, modular cementless radial component 
and non-modular cemented carpal component; 
6.3.4 Unicompartmental system with radial join t bearing, modular cementless radial component 
and non-modular cementless carpal component; 
6.3.5 Unicompartmental system with carpal post,  non-modular cemented radial component and 
modular cemented carpal component; 
6.3.6 Unicompartmental system with carpal post,  non-modular cemented radial component and 
modular cementless carpal component; 
6.3.7 Unicompartmental system with carpal post,  non-modular cementless radial component and 
modular cemented carpal component; 
6.3.8 Unicompartmental system with carpal post,  non-modular cementless radial component and 
modular cementless carpal component; 
6.3.9 Multicompartmental systems (modular radial co mponent with radial jo int bearing and metal 
ulnar pin), cemented radial component, cemente d carpal component, and metal ulnar extremity; 
6.3.10 Multicompartmental systems (modular radial co mponent with radial jo int bearing and metal 
ulnar pin), cemented radial component, cemente d carpal component, and non-metal ulnar extremity; 
6.3.11 Multicompartmental systems (modular radial co mponent with radial jo int bearing and metal 
ulnar pin), cemented radial component, cementle ss carpal component, and metal ulnar extremity; 
6.3.12 Multicompartmental systems (modular radial co mponent with radial jo int bearing and metal 
ulnar pin), cemented radial component, cem entless carpal component, and non-metal ulnar 
extremity; 
6.3.13 Multicompartmental systems (modular radial co mponent with radial jo int bearing and metal 
ulnar pin), cementless radial component, cemente d carpal component, and metal ulnar extremity; 
6.3.14 Multicompartmental systems (modular radial co mponent with radial jo int bearing and metal 
ulnar pin), cementless radial component, cem ented carpal component, and non-metal ulnar 
extremity; 
6.3.15 Multicompartmental systems (modular radial co mponent with radial jo int bearing and metal 
ulnar pin), cementless radial component, cementl ess carpal component, and metal ulnar extremity; 6.3.16 Multicompartmental systems (modular radial co mponent with radial jo int bearing and metal 
ulnar pin), cementless radial component, cem entless carpal component, and non-metal ulnar 
extremity; 
6.4 Description of possible families of  wrist joint replacement components: 
6.4.1 Family of modular unicompartment al radial components, cemented; 
6.4.2 Family of modular unicompartment al radial components, cementless; 
6.4.3 Family of non-modular unicompartmental radial components, cemented; 6.4.4 Family of non-modular unicompartmental radial components, cementless; 6.4.5 Family of modular multicompartmen tal radial components, cemented; 
6.4.6 Family of modular multicompartmen tal radial components, cementless; 
6.4.7 Family of modular carpal components, cemented; 6.4.8 Family of modular carpal components, cementless; 6.4.9 Family of modular carpal components, cemented; 6.4.10 Family of modular carpal components, cementless; 6.4.11 Family of polymer carpal bearings; 6.4.12 Family of polymer radial joint bearings; 6.4.13 Family of polymer ulnar extremities; 6.4.14 Family of metal ulnar extremities; 
6.4.15 Family of ulnar pins. 
  PART 7 – TEMPOROMANDIBULAR JOINT 7.1 The following criteria apply to specific  parts for grouping temporomandibular joint 
replacements into families and systems for registers: 
CRITERIA COMPONENTS 
Material All components 
Method of fixation (cemented/cemen tless) Mandibular fossa component 
Modularity Condylar component 
Plates and screws (fixation system for the 
condylar component) Structure – rigidity (rigid fixation / 
intermaxillary fixation)* 
* Specific criterion. 
7.2 In addition to the criteria specified in the pr evious item, the following specific criteria apply 
to temporomandibular joint replacement systems: 
CRITERIA APPLICABLE TO TH E SYSTEM* SPECIFICATION 
Composition Monolithic 
Functionality Unrestricted 
Scope of implant – with or without preservation 
of the surface of the mandibular fossa. - Total – mandibular fossa not preserved 
- Partial – mandibular fossa preserved Extent of interference with the epiphysis Full 
Range of intracomponent motion Fixed 
Extent of compartmentalisation of  the system Unicompartmental 
Joint containment structure Anatomical 
7.3 Description of possible temporoman dibular joint replacement systems: 
7.3.1 Total arthroplasty system for the TMJ with modular condylar component, cemented 
temporal component and rigi d fixation (plate/screws); 
7.3.2 Total arthroplasty system for the TMJ with modular condylar component, cementless 
temporal component and rigi d fixation (plate/screws); 
7.3.3 Total arthroplasty system for the TMJ with modular condylar component, cemented 
temporal component and intermax illary fixation (plate/screws); 
7.3.4 Total arthroplasty system for the TMJ with modular condylar component, cementless 
temporal component and intermax illary fixation (plate/screws); 
7.3.5 Total arthroplasty system for the TMJ with non-modular condylar component, cemented 
temporal component and rigi d fixation (plate/screws); 
7.3.6 Total arthroplasty system for the TMJ with non-modular condylar component, cementless 
temporal component and rigi d fixation (plate/screws); 
7.3.7 Total arthroplasty system for the TMJ with non-modular condylar component, cemented 
temporal component and intermax illary fixation (plate/screws); 
7.3.8 Total arthroplasty system for the TMJ with non-modular condylar component, cementless 
temporal component and intermax illary fixation (plate/screws); 
7.3.9 Partial arthroplasty system for the TMJ with modular condyla r component and rigid fixation 
(plate/screws); 
7.3.10 Partial arthroplasty system for the TMJ with modular condylar component and 
intermaxillary fixation (plate/screws); 
7.3.11 Partial arthroplasty system for the TMJ with non-modular condylar component and rigid 
fixation (plate/screws); 
7.3.12 Partial arthroplasty system for the T MJ with non-modular condylar component and 
intermaxillary fixation (plate/screws); 
7.4 Description of possible families of tem poromandibular joint replacement components: 
7.4.1 Family of metal condylar components; 7.4.2 Family of polymer condylar components; 7.4.3 Family of metal temporal components; 7.4.4 Family of polymer temporal components. 7.5 The plates and screws used to fix the condyl ar components must be classified according to 
the criteria for the grouping into families of plates  and families of screws  set out in the specific 
regulation. 
 PART 8 – INTERSOMATIC SPACER WITH INTR INSIC MOBILITY – DISC PROSTHESES 
FOR THE SPINAL COLUMN 8.1 Only the modularity and composition criter ia will be taken into account for grouping 
intersomatic spacers with intrin sic mobility into families. 
8.2 For the register, these devices will be  considered single composite products. 
8.3 Description of possible families of inte rsomatic spacers with intrinsic mobility: 
8.3.1 Family of modular monolithic inters omatic spacers with intrinsic mobility; 
8.3.2 Family of non-modular monolithic inters omatic spacers with intrinsic mobility; 
8.3.3 Family of modular composite inters omatic spacers with intrinsic mobility; 
8.3.4 Family of non-modular composite inters omatic spacers with intrinsic mobility; 
PART 9 – SINGLE COMPOSITE PRODUCTS 9.1 With regard to Item 5.4 of Part 5, “Requireme nts” of the technical re gulation containing the 
general requirements for grouping ORTHOPAEDIC IMPLANTS into families and systems for registers, the following items ma y be included in the register for single composite products: 
9.1.1 Implants for wholly restricted arthroplasty of elbows and knees; 
9.1.2 Implants for resurfacing the femur, cemented. 9.1.3 Implants for resurfacing the femur, cementless. 9.1.4 Implants for total constrained hip arthroplasty; 9.1.5 Implants for constrained reverse total arthroplasty; 
9.1.6 Implants for restricted total elbow arthr oplasty, without polyme r radioulnar component; 
9.1.7 Implants for restricted total elbow arthr oplasty, with polymer radioulnar component; 
9.1.8 Implants for total interphalange al joint arthroplasty (hands); 
9.1.9 Implants for total metacarpal-phalangeal arthroplasty; 9.1.10 Implants for total metacarpal-phalangeal arthroplasty of the hallux; PART 10 – UNCONVENTIONAL ENDOPROSTHESES 10.1 The following criteria apply to the produc ts for grouping unconventional endoprostheses 
into families: 
APPLICABLE CRITERIA SPECIFICATION 
Joint - Monoarticulated 
- Biarticulated - Not articulated 
Location - Lower limbs 
- Unconventional upper limbs 
10.2 Implants with resurfacing treatments aggreg ating raw materials which differ from those of 
their production are to be grouped in a different  register from implants without resurfacing 
treatment of this kind. 
10.3 Description of possible families of unconventional endoprostheses: 
10.3.1 Family of monoarticulat ed unconventional endoprostheses for lower limbs; 
10.3.2 Family of monoarticulated unconven tional endoprostheses for upper limbs; 
10.3.3 Family of biarticulated unconventional endoprostheses for lower limbs; 10.3.4 Family of biarticulated unconventional endoprostheses for upper limbs; 10.3.5 Family of non-articulated unconventi onal endoprostheses for lower limbs; 
10.3.6 Family of non-articulated unconventi onal endoprostheses for lower limbs. 
10.4 Unconventional endoprostheses are those with sp ecial characteristics du e to the anatomical 
particularities of the patients and the lesions associated with the lo cation of the implant, in addition 
to their use in specific cases, give n that they are generally used as  replacements where there is no 
anatomical standard for placing them. 
10.5 Unconventional endoprostheses may be made to measure or not, as those which have a 
defined technical design, even if the dimensions of the components vary, must be registered with 
Anvisa with regard to manufacture,  import, export, display for sale or delivery to the consumer, in 
accordance with the criteria described above. 
10.6 Unconventional endoprostheses which are made to measure, i.e. constructed from 
imagenological examination of specific cases , wit hout a standard technical design, will be dealt 
with by a specific t echnical regulation. 
 
ANNEX II 
 SPECIFIC CRITERIA FOR GROUPING OSTEOSY NTHESIS IMPLANTS INTO FAMILIES 
AND SYSTEMS FOR REGISTERS 
PART 1 – PLATES FOR OSTEOSYNTHESIS 
1.2 The following criteria apply to specific pa rts for grouping plates for osteosynthesis into 
families and systems for registers: 
CRITERIA SPECIFICATION 
Material - Absorbable 
- Non-absorbable 
Form - Straight and special* 
- Angled* (sharp angle) - Angular-Tubular 
Dimensions - Large and small fragments (>2.7mm**) 
- Mini and micro fr agments (<2.7mm**) 
* Special plates can be bent along the same Cartesian plane as the holes (two-dimensional 
deformation), while within angled plates the bendi ng occurs in a Cartesian plane which differs from 
that of the perforated surface (three-dimensional deformation). 
**In reference to the internal diameter of the hole in the plate. 1.2 In addition to the criteria speci fied in the previous item, the following specific criteria apply 
to plates for osteosynthesis: 
CRITERIA APPLICABLE TO TH E SYSTEM SPECIFICATION 
Rigidity of the fixation* - Rigid fixation 
- Non-rigid fixation 
* Rigidity refers to the presence or absence of devices which prevent movement between the plate 
and screw components (threaded holes or clamping systems). 
1.3 Description of possible systems of non-rigid plates for osteosynthesis: a.1) Non-rigid, non-absorbable fixation system w ith tube plate, sliding nail and compression or 
blocking screw; 
a.2) Non-rigid, non-absorbable fixation syst em for mini and micro fragments (including 
deformable plates for reconstruction); 
a.3) Non-rigid, absorbable fixation system for mini and micro fragment s (including deformable 
plates for reconstruction); 
1.4 Description of possible families of non-rigid plates for osteosynthesis: 
b) Families of non-absorbable plates:  
b.1) Family of plates for large and small fragments; b.2) Family of plates for mini and micro fragments; b.3) Family of angular tube plates b.4) Family of angular plates; c) Families of absorbable plates:
 
c.1) Family of plates for large and small fragments;  c.2) Family of plates for mini and micro fragments. 1.5 Rigid fixation plates for osteosynthesis, t ogether with their rigid fixation screws, are 
recorded in registers of systems accord ing to the following characteristics: 
d.1) Rigid fixation system for plates for large and small fragments; 
d.2) Rigid fixation system for plates  for mini and micro fragments; 
d.3) Rigid fixation system for a ngular tube plates (including the relevant sliding nail and 
compression or blocking screws). 
d.4) Rigid fixation system for angular plates. 1.6 Rigid fixation systems permit the use of th e following accessories: screw plugs, threaded 
spacers and washers. 
PART 2 – SCREWS FOR OSTEOSYNTHESIS 2.1 The following criteria apply to specific pa rts for grouping screws for osteosynthesis into 
families and systems for registers: 
CRITERIA SPECIFICATION 
Material - Absorbable 
- Non-absorbable 
Geometry - Cannulated 
- Uncannulated 
Dimensions - Large and small fragments 
- Mini and micro fragments 
Position - Osteosynthesis  
- Ligamentoplasty 
Rigidity of the fixation* - Rigid fixation 
- Non-rigid fixation 
Use (re: application to angulated plates or - Applicable intramedullary nails) - Not applicable 
* Rigidity refers to the presence or absence of devices which prevent movement between the plate 
and screw components (threaded holes or clamping systems). 
2.2 Description of possible families of osteosynthesis screws: a) Families of non-absorbable screws – w ithout rigid fixation for osteosynthesis:
 
a.1) Family of sliding nails (compression or bl ocking screws), applica tion to angulated tube 
plates or intramedullary nails; 
a.2) Families of screws for large and small fragments, cannulated; a.3) Families of screws for mini and micro fragments, cannulated; a.4) Families of screws for large and small fragments, uncannulated; a.5) Families of screws for mini and micro fragments, uncannulated; 
a.6) Families of screws with clamps, cannulated; a.7) Families of screws with clamps, uncannulated. b) Families of non-absorbable screws – w ithout rigid fixation for ligamentoplasty:
 
b.1) Families of screws for ligament fixa tion, uncannulated (screws and cross-nails); 
b.2) Families of screws for ligament fixation, cannulated; b.3) Families of blocking, compression, clamp and other related screws, including nails and 
blocking screws for intramedullary nails; 
c) Families of non-absorbable screws – with rigid fixation for osteosynthesis:
 
c.1) Families of expandable head screws for plat e fixation (a single composite product with the 
related clamp screw); 
c.2) Families of screws for plate fixation w ith the lower surface of  the head threaded; 
d) Families of absorbable screws – without rigid fixation for osteosynthesis:  
d.1) Families of screws for large and small fragments, cannulated; d.2) Families of screws for mini and micro fragments, cannulated; 
d.3) Families of screws for large and small fragments, uncannulated; d.4) Families of screws for mini a nd micro fragments, uncannulated; 
e) Families of non-absorbable screws – w ithout rigid fixation for ligamentoplasty:
 
e.1) Ligament fixation, uncannulat ed (screws and cross-nails); 
e.2) Ligament fixation, cannulated. f) Families of non-absorbable screws – w ithout rigid fixation for ligamentoplasty:
 
f.1) Ligament fixation, uncannulat ed (screws and cross-nails); 
f.2) Ligament fixation, cannulated. 2.3 Washers and bolts are the accessories permitted for these products. PART 3 – OSTEOSYNTHESIS CLIPS 3.1 Only the material criterion, without any sp ecific criteria, will be taken into account for 
grouping osteosynthesis clips into families. 3.2 Clips which are part of a device will be classified with that com ponent as sets or kits for the 
purpose of a register. 
3.3 Description of possible families of osteosynthesis clips: 3.3.1 Families of clips with an absorbable component; 3.3.2 Families of clips with a non-absorbable component. PART 4 - FLEXIBLE WIRES AND CABLES 
4.1 Only the material criterion, without any sp ecific criteria, will be taken into account for 
grouping flexible wires and cables fo r osteosynthesis into families. 
4.2 Description of possible families of flexible wires and cables: 
4.2.1 Family of metal non-absorbabl e flexible wires and cables; 
4.2.2 Family of non-metallic non-absorbable flexible wires and cables; 4.2.3 Family of absorbable flexible wi res and cables (not including sutures). 
PART 5 – NAILS AND RIGID WIRES 5.1 Only the material criterion, without any sp ecific criteria, will be taken into account for 
grouping nails and rigid wires for osteosynthesis into families. 
5.2 Description of possible familie s of nails and rigid wires: 
5.2.1 Family of metal non-absorba ble nails and rigid wires; 
5.2.2 Family of absorbable nails and rigid wires. 
PART 6 – INTRAMEDULLARY NAILS 
6.1 The following criteria apply to specific part s for grouping intramedullary nails into families 
and systems for registers: 
CRITERIA SPECIFICATION 
Rigidity associated with the structure - Flexible 
- Semi-rigid 
Method of fixation - Blocked 
- Not blocked 
Method of blocking - Internal expansion 
- Exclusively by transverse screw - Mixed 
Application (only for systems) - Femoral 
- Tibial - Humeral 
 
6.2 Description of possible in tramedullary nail systems: 
6.2.1. Semi-rigid nail system with tran sverse blocking sc rew – femoral; 
6.2.2. Semi-rigid nail system with tran sverse blocking screw – tibial; 
6.2.3. Semi-rigid nail system with tran sverse blocking screw – humeral; 
6.2.4. Semi-rigid nail system with mixed blocking – sc rews and sliding nail or spring – femoral; 
6.2.5 Semi-rigid nail system with mixed blocking – screws and sliding nail or spring – humeral; 6.3 Description of possible intramedullary nail families: 
6.3.1. Family of flexible nails; 6.3.2. Family of semi-rigid nails without blocking; 6.3.3. Family of semi-rigid nails with blocking via internal expansion; 
6.3.4. Family of semi-rigid nails with  blocking via transverse screws; 
6.3.5. Semi-rigid nail family with mixed blocking – screws and sliding nail or spring. 6.4 The screws and nails used with the intramedu llary nails are not accessories and therefore are 
not grouped into families for registers as they must  have their own register in accordance with the 
criteria for grouping screws. 
6.5 Screw plugs form a single composite product with intramedullary nails and must be 
including in the register as  part of the same family. 
PART 7 – ORTHOPAEDIC SUTURE ANCHORS 7.1 The following criteria apply to specific part s for grouping orthopaedic suture anchors into 
families and systems for registers: 
CRITERION SPECIFICATION 
Material - Absorbable 
- Non-absorbable 
Presence of insertion device - With device 
- Without device 
7.2 Insertion devices may only be included as pa rt of the product if reprocessing is prohibited 
and they are presented in the same way as the implants, as described below. 
7.2.1 Single composite product containing an absorbab le anchor and absorbable suture mounted 
in an insertion device; 
7.2.2 Single composite product containing an abso rbable anchor and non-absorbable suture 
mounted in an insertion device; 
7.2.3 Single composite product containing a non-abso rbable anchor and absorbable suture 
mounted in an insertion device; 
7.2.4 Single composite product containing a non-abso rbable anchor and non-absorbable suture 
mounted in an insertion device; 
7.2.5 Single composite product containing a non-abso rbable anchor and partially absorbable 
suture mounted in an insertion device; 
7.2.6 Single composite product containing an absorbab le anchor and partially absorbable suture 
mounted in an insertion device; 
7.3 For the composite products described in 7.2, th e only permissible variation within the same 
register is the dimension of the anchors. 
7.4 Single composite products containing an an chor and suture may or may not include a 
needle. 
7.5 Description of possible families of orthopaedic suture anchors: 
7.5.1 Families of absorbable anchors; 7.5.2 Family of single composite products containing an absorbable anchor and absorbable suture; 7.5.3 Family of single composite products containi ng an absorbable anchor and non-absorbable 
suture; 
7.5.4 Families of non-absorbable anchors; 7.5.5 Family of single composite products c ontaining a non-absorbable anchor and non-
absorbable suture; 
7.5.6 Family of single composite products contai ning a non-absorbable anchor and absorbable 
suture; 
7.5.7 Family of single composite products contai ning a non-absorbable an chor and partially 
absorbable suture; 
7.5.8 Family of single composite products contai ning an absorbable anchor and partially 
absorbable suture; 
PART 8 – GRAFT BEARING DIAPHYSEAL SPACERS 8.1 Only the material criterion, without any sp ecific criteria, will be taken into account for 
grouping graft bearing diaphys eal spacers into families. 
8.2 Description of possible families of  graft bearing diaphyseal spacers: 
8.2.1 Families of non-absorbable spacers; 8.2.2 Families of absorbable spacers. PART 9 - IMPLANTABLE MANDIBULAR BRACES 
9.1 Only the material criterion, without any sp ecific criteria, will be taken into account for 
grouping implantable mandibular braces into families. 
9.2 Description of possible families of implantable mandibular braces: 
9.2.1 Families of non-absorbable implantable mandibular braces; 9.2.2 Families of absorbable implantable mandibular braces. PART 10 – HALO BRACE 10.1 Halo braces are considered single composite products, comp rising a metallic halo with 
screw holes and metal screws to fix the halo, and may be registered as single articles or families, but 
never as systems. 
10.2 This classification includes th e unthreaded cranial haloes (bu ttons) with or without sutures, 
since sutures are required fo r the implant to function. 
10.3 Only the material criterion, without any sp ecific criteria, will be taken into account for 
grouping cranial fixation apparatus into families. 
10.4 Description of possible families of cranial fixation apparatus: 
10.4.1 Family of non-absorbable cranial fixation apparatus; 
10.4.2 Family of absorbable cranial fixation apparatus. 10.5 Connectors for plaster or polymer collars are considered accessories to this system. 
ANNEX III SPECIFIC CRITERIA FOR GROUPING SPINA L IMPLANTS INTO FAMILIES AND 
SYSTEMS FOR REGISTERS 
PART 1 – GRAFT BEARING INTERSOMATIC SPACERS 1.1 Intersomatic spacers are considered to include  vertebral spacers for replacing intervertebral 
disks and fusion cylinders for replacing th e vertebral body and intervertebral disk. 
1.2 Intersomatic spacers for replacing intervertebr al disks and fusion cylinders for replacing the 
vertebral body and intervertebral disk must be grouped in separate registers according to their application. 
1.3 The following criteria apply to specific part s for grouping graft bearing intersomatic spacers 
into families and systems for registers: 
CRITERIA SPECIFICATION 
Indication - Disk replacement 
- Body and disk replacement 
Material - Absorbable 
- Non-absorbable 
Architecture - Expandable 
- Not expandable 
 
1.4 Description of possible families of graft bearing intersomatic spacers: 
1.4.1 Families of non-absorbable, expandable, meta l intersomatic spacers for replacing the disk; 
1.4.2 Families of non-absorbable, non-expandable, metal intersomatic spacers for replacing the 
disk; 
1.4.3 Families of non-absorbable, non-expandable, po lymer intersomatic spacers for replacing the 
disk; 
1.4.4 Families of non-absorbable, non-expandable, ceramic intersomatic spacers for replacing the 
disk; 
1.4.5 Families of absorbable intersoma tic spacers for replacing the disk; 
1.4.6 Families of non-absorbable, expandable, me tal intersomatic spacers for replacing the body 
and disk; 
1.4.7 Families of non-absorbable, non-expandable, metal intersomatic spacers for replacing the 
body and disk; 
1.4.8 Families of non-absorbable, non-expandable, po lymer intersomatic spacers for replacing the 
body and disk; 
1.4.9 Families of non-absorbable, non-expandable, ceramic intersomatic spacers for replacing the 
body and disk; 
1.4.10 Families of absorbable intersomatic  spacers for replacing the body and disk. 
PART II – SPINAL IMPLANT SYSTEMS 
The following criteria apply to specific parts fo r grouping spinal implant systems into families and 
systems for registers: 
CRITERIA SPECIFICATION 
Materials - Metal 
- Polymer - Ceramic 
Rigidity associated with the structure - Flexible - Rigid 
Fixation structures - Bars and wires 
- Plates and screws - Nails/screws/hooks. 
Direction of implant - Anterior 
- Posterior / postero-lateral 
3.2 Description of possible anterior systems for intersomatic fixation: 
3.2.1 Metal anterior systems for intersomatic fixati on using plates (Metal pl ates, metal screws for 
plate fixation with or without clamping syst em, screws to clamp the fixation screws); 
3.2.2. Non-absorbable polymer anterior systems for intersomatic fixation using plates (Polymer 
plates, metal or polymer screws for plate fixation with or without clamping system, screws to clamp 
the fixation screws). 
3.2.3. Anterior systems for intersomatic fixation with  connecting pins (Devices for fixation to the 
vertebral body, screws with or without clamping system for c oupling the pin and affixing the 
devices to the verteb ral body, screws to clamp the fi xation screws, connecting pins). 
3.3 Description of posterior syst ems for intersomatic fixation: 
3.3.1 Posterior systems of flexible components w ith pedicle screws (Flexible cables, pedicle 
screw); 
3.3.2 Rigid posterior systems with flat bars fixed by wires - peri pheral fixation to the lamina, 
pedicle or apophysis (laminar hooks , metal wires, polymer wires); 
3.3.3 Rigid posterior systems with me tal plates fixed by intrasomatic screws – through the pedicle 
or the body of the joint (straight an d/or hooked plate, fixation screws); 
3.3.4. Rigid posterior systems with non-absorbable po lymer plates fixed by in trasomatic screws – 
through the pedicle or th e body of the joint (straight and/or hooked plate, metal and/or polymer 
fixation screws); 
3.3.5. Rigid posterior systems with pins fixed by intrasomatic or intraoccipital screws and/or 
hooks - peripheral fixation to the lamina, pedi cle or apophysis (wires fixed by laminar hooks, 
laminar hooks, pedicle hooks, apophyseal hooks, occipi tal screws, mono-axial / poly-axial pedicle 
screws, clamping screws, blocking screws, conn ectors, ball and socket joints, stabilisers).