Source: http://www.readbag.com/accessdata-fda-cdrh-docs-pdf5-k051738
Timestamp: 2019-06-20 23:55:18
Document Index: 207875171

Matched Legal Cases: ['§888', 'arts 800', 'art 807', 'art 801', 'art 820', 'art 801', 'art 807']

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Line Extension to the SecufFit'&quot; and Secur-Fit&quot; Plus Max -lip Stem
Special 5 10(k) Premarket Notification
JUL 1 9 2005
510(k) Summary of Safety and Effectiveness Line Extension to the Secur-Fit Max and Secur-Fit
T Secur-Fit TM Max and Secur-Fit'
Plus Max Hip Stem
Proprietary Name: Common Name: Proposed Regulatory Class: Classification:
Plus Max Hip Stems
Artificial Hip Components Class II Hip joint, metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prostheses, 21 CFR §888.3353. 87 MEH, Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate and 87 LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Product Code:
Karen Ariemma, Senior Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Telephone: (201) 831-5718 Fax: (201) 831-6038 Email: karen.ariemma~stryker.com
Date Summary Prepared: Device Description
alloy hip M The subject Secur-FitF Max Hip and Secur-Fit Plus Max Hip Stems are titanium coating stems. The hip stems have a Commercially Pure Titanium arc deposited circumferential for cementless with a PureFixTM HA hydroxylapatite surface treatment. The stems are intended to 40mn. The fixation and are available in stem sizes 4-14 and neck lengths ranging from 25mm Hip stems have a stems are available with either a 1270 or 1320 neck angle. The Secur-Fit M Max TM Plus Max Hip Stems have a fluted and slotted distal tapered distal geometry. The Secur-Fit
Line Extension to the Secur-Fit' and Secur-Fit Plus Max Hip Stem
Device Modification This Secur-Fit Max and the Secur-Fit
Plus Max Hip Stems were cleared for use with metal
and Alumina Ceramic Heads. This submission adds the use of a C-Taper Biolox® Delta Ceramic T Femoral Head with the Secur-FitT Max and the Secur-Fit Plus Max Hip Stems.
Intended Use ' The Secur-Fit &quot; Max and the Secur-Fit
Plus Max Hip Stems are single-use devices and are
intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty.
Indications for Use The indications for use of the Osteonics® Secur-FitTM HA and Secur-FitTM Plus Hip Stems as a Total Hip Replacement include: * * * * * Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed; and Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Substantial Equivalence The features of the subject components are substantially equivalent to the predicate devices based on similarities in intended use and design. Mechanical testing demonstrates substantial equivalence of the subject components to the predicate devices in regards to mechanical strength. In addition, the intended use, manufacturing methods, packaging, and sterilization of the
T predicate and subject components are identical. The material of the subject Secur-Fit Max and the Secur-Fit M Plus Max Hip Stems remains unchanged. The subject ceramic femoral heads are
fabricated from Zirconia toughened Alumina.
Public Health Service Food and Drug Administration 9200 Corporate Boulevard
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Ms. Karen Ariemma Senior Regulatory Affairs Specialist Howmedica Osteonics Corp. Mahwah, New Jersey 07430 Re: K051738 Max Hip Stems Trade/Device Name: SECUR-FitTM Max and SECUR-FITTM PLUS Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: 11 Product Code: LZO, MEH Dated: June 27, 2005 Received: June 28, 2005 Dear Ms. Karen Ariemma: intent to market the device We have reviewed your Section 510(k) premarket notification of equivalent (for the indications referenced above and have determined the device is substantially marketed in interstate for use stated in the enclosure) to legally marketed predicate devices the Medical Device Amendments, or to commerce prior to May 28, 1976, the enactment date of of the Federal Food, Drug, devices that have been reclassified in accordance with the provisions approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarket provisions of the Act. The You may, therefore, market the device, subject to the general controls registration, listing of general controls provisions of the Act include requirements for annual against misbranding and devices, good manufacturing practice, labeling, and prohibitions adulteration. Controls) or class III (PMA), it If your device is classified (see above) into either class II (Special affecting your device can may be subject to such additional controls. Existing major regulations to 898. In addition, FDA may be found in the Code of Federal Regulations, Title 21, Parts 800 Register. publish further announcements concerning your device in the Federal determination does not mean Please be advised that FDA's issuance of a substantial equivalence other requirements of the Act that FDA has made a determination that your device complies with agencies. You must or any Federal statutes and regulations administered by other Federal to: registration and listing (21 comply with all the Act's requirements, including, but not limited practice requirements as set CFR Part 807); labeling (21 CFR Part 801); good manufacturing and if applicable, the electronic forth in the quality systems (QS) regulation (21 CFR Part 820); 21 CFR 1000-1050. product radiation control provisions (Sections 531-542 of the Act);
Page 2 - Ms. Karen Ariemma as described in your Section 510(k) This letter will allow you to begin marketing your device of your device to a legally premarket notification. The FDA finding of substantial equivalence device and thus, permits your device marketed predicate device results in a classification for your . . to proceed to the market ... regulation (21 CFR Part 801), please If you desire specific advice for your device on our labeling please note the regulation entitled, contact the Office of Compliance at (240) 276-0120. Also, Part 807.97). You may obtain &quot;Misbranding by reference to premarket notification&quot; (21CFR Act from the Division of Small other general information on your responsibilities under the its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistance at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours,
Miriam C. Provost, Ph.D
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Indications for Use 5 10(k) Number (if known):
Device Name: SECUR-FIT
M Max and SECUR-FIT T PLUS Max Hip Stems
The Secur-FitTM Max and Secur-FitTM Plus Max Hip Stems are single-use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty.
The indications for use of the Secur-FitTM Max and Secur-FitTM Plus Max4-Iip Stems as a Total Hip Replacement include: * * · * * Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed; and Treatment of non-union, fenoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Over-The-CounteriUse
Concurrence of CDRH, Office of Device Evaluation (ODE) Page I of I
Divisionf of Gjcnenl, lRestorative fl.'..,.cDee