Source: http://www.boydtech.com/device-finder/orthopedic
Timestamp: 2019-02-18 00:36:24
Document Index: 379848351

Matched Legal Cases: ['art 888', '§888', 'art 807', '§888', '§888', 'art 807', '§888', 'art 807', 'art 898', 'art 807', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', 'art 3', 'art 4', 'art 12', 'art 2', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', 'art 3', 'art 4', 'art 12', 'art 2', 'art 2', '§888', '§888', '§888', '§888', '§888', 'art 3', 'art 4', 'art 12', 'art 2', '§888', 'art 3', 'art 4', 'art 12', 'art 2', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888', '§888']

Orthopedic | Boyd Technologies
Orthopedic devices are medical devices, tools, and accessories used to replace damaged bone, reduce pain, and improve the skeletal function of a patient. The FDA regulates these devices under CFR Title 21 Part 888, and the devices are categorized into three subparts.
Orthopedic Diagnostic Devices
§888.1100
Classification. (1) Class II (performance standards). (2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 888.9.
AC-powered dynamometer.
§888.1240
Identification. An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient&#39;s hand.
Nonpowered dynamometer.
§888.1250
Identification. A nonpowered dynamometer is a mechanical device intended for medical purposes to measure the pinch and grip muscle strength of a patient&#39;s hand.
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807.
§888.1500
Classification. (1) Class I (general controls) for a goniometer that does not use electrode lead wires and patient cables. This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to 888.9. (2) Class II (special controls) for a goniometer that uses electrode lead wires and patient cables. The special controls consist of: (i) The performance standard under part 898 of this chapter, and (ii) The guidance entitled Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables. This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to 888.9.
Nonpowered goniometer.
§888.1520
Identification. A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.
§888.3000
Bone fixation cerclage.
§888.3010
Bone heterograft.
§888.3015
Identification. Bone heterograft is a device intended to be implanted that is made from mature (adult) bovine bones and used to replace human bone following surgery in the cervical region of the spinal column.
Intramedullary fixation rod.
§888.3020
Passive tendon prosthesis.
§888.3025
Polymethylmethacrylate (PMMA) bone cement.
§888.3027
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.
Single/multiple component metallic bone fixation appliances and accessories.
§888.3030
§888.3040
§888.3045
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA. See 888.1(e) of this chapter for the availability of this guidance.
Spinal interlaminal fixation orthosis.
§888.3050
Spinal intervertebral body fixation orthosis.
§888.3060
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct sway back, scoliosis (lateral curvature of the spine), or other conditions.
Thoracolumbosacral pedicle screw system.
§888.3070
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient&#39;s anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors). (2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls: (i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown. Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient. (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
§888.3080
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled Class II Special Controls Guidance Document: Intervertebral Body Fusion Device. See 888.1(e) for the availability of this guidance document. (2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
Ankle joint metal/composite semi-constrained cemented prosthesis.
§888.3100
Identification. An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation: in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component fabricated from ultra-high molecular weight polyethylene with carbon fibers composite, and is limited to those prostheses intended for use with bone cement (888.3027).
Ankle joint metal/polymer semi-constrained cemented prosthesis.
§888.3110
Ankle joint metal/polymer non-constrained cemented prosthesis.
§888.3120
Identification. An ankle joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (888.3027).
Elbow joint metal/polymer constrained cemented prosthesis.
§888.3150
Classification. Class II. The special controls for this device are: (1) FDA&#39;s: (i) Use of International Standard ISO 10993 Biological Evaluation of Medical DevicesPart I: Evaluation and Testing, (ii) 510(k) Sterility Review Guidance of 2/12/90 (K90-1), (iii) Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, (iv) Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices, (v) Guidance Document for Testing Non-articulating, Mechanically Locked Modular Implant Components, (2) International Organization for Standardization&#39;s (ISO): (i) ISO 5832-3:1996 Implants for SurgeryMetallic MaterialsPart 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy, (ii) ISO 5832-4:1996 Implants for SurgeryMetallic MaterialsPart 4: Cobalt-Chromium-Molybdenum Casting Alloy, (iii) ISO 5832-12:1996 Implants for SurgeryMetallic MaterialsPart 12: Wrought Cobalt-Chromium-Molybdenum Alloy, (iv) ISO 5833:1992 Implants for SurgeryAcrylic Resin Cements, (v) ISO 5834-2:1998 Implants for SurgeryUltra High Molecular Weight PolyethylenePart 2: Moulded Forms, (vi) ISO 6018:1987 Orthopaedic ImplantsGeneral Requirements for Marking, Packaging, and Labeling, (vii) ISO 9001:1994 Quality SystemsModel for Quality Assurance in Design/Development, Production, Installation, and Servicing, and (viii) ISO 14630:1997 Non-active Surgical ImplantsGeneral Requirements, (3) American Society for Testing and Materials&#39;: (i) F 75-92 Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material, (ii) F 648-98 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants, (iii) F 799-96 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants, (iv) F 981-93 Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone, (v) F 1044-95 Test Method for Shear Testing of Porous Metal Coatings, (vi) F 1108-97 Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants, (vii) F 1147-95 Test Method for Tension Testing of Porous Metal Coatings, and (viii) F 1537-94 Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.
Elbow joint metal/polymer semi-constrained cemented prosthesis.
§888.3160
Elbow joint radial (hemi-elbow) polymer prosthesis.
§888.3170
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.
Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.
§888.3180
Identification. An elbow joint humeral (hemi-elbow) metallic uncemented prosthesis is a device intended to be implanted made of alloys, such as cobalt-chromium-molybdenum, that is used to replace the distal end of the humerus formed by the trochlea humeri and the capitulum humeri. The generic type of device is limited to prostheses intended for use without bone cement (888.3027).
Finger joint metal/metal constrained uncemented prosthesis.
§888.3200
Identification. A finger joint metal/metal constrained uncemented prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. The device prevents dislocation in more than one anatomic plane and consists of two components which are linked together. This generic type of device includes prostheses made of alloys, such as cobalt-chromium-molybdenum, or protheses made from alloys and ultra-high molecular weight polyethylene. This generic type of device is limited to prostheses intended for use without bone cement (888.3027).
Finger joint metal/metal constrained cemented prosthesis.
§888.3210
Identification. A finger joint metal/metal constrained cemented prosthesis is a device intended to be implanted to replace a metacarpophalangeal (finger) joint. This device prevents dislocation in more than one anatomic plane and has components which are linked together. This generic type of device includes prostheses that are made of alloys, such as cobalt-chromium-molybdenum, and is limited to those prostheses intended for use with bone cement (888.3027).
Finger joint metal/polymer constrained cemented prosthesis.
§888.3220
Finger joint polymer constrained prosthesis.
§888.3230
Identification. A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve.
§888.3300
§888.3310
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.
§888.3320
§888.3330
§888.3340
§888.3350
§888.3353
§888.3358
§888.3360
Hip joint (hemi-hip) acetabular metal cemented prosthesis.
§888.3370
Identification. A hip joint (hemi-hip) acetabular metal cemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have an acetabular component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).
Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.
§888.3380
Identification. A hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that consist of a metallic stem made of alloys, such as cobalt-chromium-molybdenum, with an integrated cylindrical trunnion bearing at the upper end of the stem that fits into a recess in the head of the device. The head of the device is made of polyacetal (polyoxymethylene) and it is covered by a metallic alloy, such as cobalt-chromium-molybdenum. The trunnion bearing allows the head of the device to rotate on its stem. The prosthesis is intended for use with bone cement (888.3027).
§888.3390
Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
§888.3400
§888.3410
Identification. A hip joint metal/polymer or ceramic/polymer semi-constrained resurfacing cemented prosthesis is a two-part device intended to be implanted to replace the articulating surfaces of the hip while preserving the femoral head and neck. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device includes prostheses that consist of a femoral cap component made of a metal alloy, such as cobalt-chromium-molybdenum, or a ceramic material, that is placed over a surgically prepared femoral head, and an acetabular resurfacing polymer component. Both components are intended for use with bone cement (888.3027).
Knee joint femorotibial metallic constrained cemented prosthesis.
Knee joint femorotibial metal/polymer constrained cemented prosthesis.
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component&#39;s flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).
Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
§888.3535
dentification. A knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surface. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra-high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial baseplate.
Classification. Class II (special controls). The special control is FDA&#39;s guidance: Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA. See 888.1 for the availability of this guidance.
Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
§888.3540
Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (888.3027). The patellar component is designed to be implanted only with its femoral component.
Classification. Class II. The special controls for this device are: (1) FDA&#39;s: (i) Use of International Standard ISO 10993 Biological Evaluation of Medical DevicesPart I: Evaluation and Testing, (ii) 510(k) Sterility Review Guidance of 2/12/90 (K90-1), (iii) Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, (iv) Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices, and (v) Guidance Document for Testing Non-articulating, Mechanically Locked Modular Implant Components, and (2) International Organization for Standardization&#39;s (ISO): (i) ISO 5832-3:1996 Implants for SurgeryMetallic MaterialsPart 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy, (ii) ISO 5832-4:1996 Implants for SurgeryMetallic MaterialsPart 4: Cobalt-Chromium-Molybdenum Casting Alloy, (iii) ISO 5832-12:1996 Implants for SurgeryMetallic MaterialsPart 12: Wrought Cobalt-Chromium-Molybdenum Alloy, (iv) ISO 5833:1992 Implants for SurgeryAcrylic Resin Cements, (v) ISO 5834-2:1998 Implants for SurgeryUltra-high Molecular Weight PolyethylenePart 2: Moulded Forms, (vi) ISO 6018:1987 Orthopaedic ImplantsGeneral Requirements for Marking, Packaging, and Labeling, (vii) ISO 7207-2:1998 Implants for SurgeryComponents for Partial and Total Knee Joint ProsthesesPart 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials, and (viii) ISO 9001:1994 Quality SystemsModel for Quality Assurance in Design/Development, Production, Installation, and Servicing, and (3) American Society for Testing and Materials&#39;: (i) F 75-92 Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material, (ii) F 648-98 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants, (iii) F 799-96 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants, (iv) F 1044-95 Test Method for Shear Testing of Porous Metal Coatings, (v) F 1108-97 Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants, (vi) F 1147-95 Test Method for Tension Testing of Porous Metal Coatings, (vii) F 1537-94 Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants, and (viii) F 1672-95 Specification for Resurfacing Patellar Prosthesis.
Knee joint femoral (hemi-knee) metallic uncemented prosthesis.
§888.3570
Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.
§888.3580
Classification. (1) Class II when intended for treatment of degenerative and posttraumatic patellar arthritis. (2) Class III when intended for uses other than treatment of degenerative and posttraumatic patellar arthritis.
Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.
§888.3590
Identification. A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This prosthesis is made of alloys, such as cobalt-chromium-molybdenum, and is intended to resurface one tibial condyle. The generic type of device is limited to those prostheses intended for use without bone cement (888.3027).
Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.
§888.3640
Identification. A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid component made of this alloy or a combination of this alloy and ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).
Shoulder joint metal/polymer non-constrained cemented prosthesis.
§888.3650
Classification. Class II. The special controls for this device are: (1) FDA&#39;s: (i) Use of International Standard ISO 10993 Biological Evaluation of Medical DevicesPart I: Evaluation and Testing, (ii) 510(k) Sterility Review Guidance of 2/12/90 (K90-1), (iii) Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, (iv) Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices, and (v) Guidance Document for Testing Non-articulating, Mechanically Locked Modular Implant Components, (2) International Organization for Standardization&#39;s (ISO): (i) ISO 5832-3:1996 Implants for SurgeryMetallic MaterialsPart 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy, (ii) ISO 5832-4:1996 Implants for SurgeryMetallic MaterialsPart 4: Cobalt-Chromium-Molybdenum Casting Alloy, (iii) ISO 5832-12:1996 Implants for SurgeryMetallic MaterialsPart 12: Wrought Cobalt-Chromium-Molybdenum Alloy, (iv) ISO 5833:1992 Implants for SurgeryAcrylic Resin Cements, (v) ISO 5834-2:1998 Implants for SurgeryUltra-high Molecular Weight PolyethylenePart 2: Moulded Forms, (vi) ISO 6018:1987 Orthopaedic ImplantsGeneral Requirements for Marking, Packaging, and Labeling, and (vii) ISO 9001:1994 Quality SystemsModel for Quality Assurance in Design/Development, Production, Installation, and Servicing, and (3) American Society for Testing and Materials&#39;: (i) F 75-92 Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material, (ii) F 648-98 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants, (iii) F 799-96 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants, (iv) F 1044-95 Test Method for Shear Testing of Porous Metal Coatings, (v) F 1108-97 Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants, (vi) F 1147-95 Test Method for Tension Testing of Porous Metal Coatings, (vii) F 1378-97 Specification for Shoulder Prosthesis, and (viii) F 1537-94 Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.
§888.3660
Classification. Class II. The special controls for this device are: (1) FDA&#39;s: (i) Use of International Standard ISO 10993 Biological Evaluation of Medical DevicesPart I: Evaluation and Testing, (ii) 510(k) Sterility Review Guidance of 2/12/90 (K90-1), (iii) Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, (iv) Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices, and (v) Guidance Document for Testing Non-articulating, Mechanically Locked Modular Implant Components, (2) International Organization for Standardization&#39;s (ISO): (i) ISO 5832-3:1996 Implants for SurgeryMetallic MaterialsPart 3: Wrought Titanium 6-aluminum 4-vandium Alloy, (ii) ISO 5832-4:1996 Implants for SurgeryMetallic MaterialsPart 4: Cobalt-chromium-molybdenum casting alloy, (iii) ISO 5832-12:1996 Implants for SurgeryMetallic MaterialsPart 12: Wrought Cobalt-chromium-molybdenum alloy, (iv) ISO 5833:1992 Implants for SurgeryAcrylic Resin Cements, (v) ISO 5834-2:1998 Implants for SurgeryUltra-high Molecular Weight PolyethylenePart 2: Moulded Forms, (vi) ISO 6018:1987 Orthopaedic ImplantsGeneral Requirements for Marking, Packaging, and Labeling, and (vii) ISO 9001:1994 Quality SystemsModel for Quality Assurance in Design/Development, Production, Installation, and Servicing, and (3) American Society for Testing and Materials&#39;: (i) F 75-92 Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material, (ii) F 648-98 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants, (iii) F 799-96 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants, (iv) F 1044-95 Test Method for Shear Testing of Porous Metal Coatings, (v) F 1108-97 Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants, (vi) F 1147-95 Test Method for Tension Testing of Porous Metal, (vii) F 1378-97 Standard Specification for Shoulder Prosthesis, and (viii) F 1537-94 Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.
§888.3670
Classification. Class II (special controls). The special control for this device is FDA&#39;s Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.
Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
§888.3680
Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component made of alloys, such as cobalt-chromium-molybdenum, or alloys with ultra-high molecular weight polyethylene and intended to be implanted to replace part of a shoulder joint. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).
Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
§888.3690
Toe joint polymer constrained prosthesis.
§888.3720
Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.
Toe joint phalangeal (hemi-toe) polymer prosthesis.
§888.3730
Wrist joint carpal lunate polymer prosthesis.
§888.3750
Wrist joint carpal scaphoid polymer prosthesis.
§888.3760
Wrist joint carpal trapezium polymer prosthesis.
§888.3770
Wrist joint polymer constrained prosthesis.
§888.3780
Identification. A wrist joint polymer constrained prosthesis is a device made of polyester-reinforced silicone elastomer intended to be implanted to replace a wrist joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.
Wrist joint metal constrained cemented prosthesis.
§888.3790
Identification. A wrist joint metal constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device prevents dislocation in more than one anatomic plane and consists of either a single flexible across-the-joint component or two components linked together. This generic type of device is limited to a device which is made of alloys, such as cobalt-chromium-molybdenum, and is limited to those prostheses intended for use with bone cement (888.3027).
Wrist joint metal/polymer semi-constrained cemented prosthesis.
§888.3800
Wrist joint ulnar (hemi-wrist) polymer prosthesis.
§888.3810
Calipers for clinical use.
§888.4150
§888.4200
Cement mixer for clinical use.
§888.4210
Cement monomer vapor evacuator.
§888.4220
Cement ventilation tube.
§888.4230
§888.4300
§888.4540
Sonic surgical instrument and accessories/attachments.
§888.4580
Protractor for clinical use.
§888.4600
§888.4800
Nonpowered orthopedic traction apparatus and accessories.
§888.5850
Identification. A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.
§888.5890
Identification. A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does not penetrate the skin and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic pulling force may be applied to the patient&#39;s body.
Cast component.
§888.5940
Cast removal instrument.
§888.5960
Manual cast application and removal instrument.
§888.5980
Identification. A manual cast application and removal instrument is a nonpowered hand-held device intended to be used in applying or removing a cast. This generic type of device includes the cast knife, cast spreader, plaster saw, plaster dispenser, and casting stand.