HOWMEDICA OSTEONICS FEMORAL HEADS

• K Number: K993601
• Device Name: HOWMEDICA OSTEONICS FEMORAL HEADS
• Manufacturer: HOWMEDICA OSTEONICS CORP.
• Date Cleared: 1999-11-16 ( 22 days)
• Product Code: LWJ , AND , JDI
• Regulation Number: 888.3360
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: N/A
• Predicate For: K022077 , K153345

Intended Use

These devices are modular components of a total hip system. These femoral heads are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.

Device Description

This Special 510(k) submission is intended to address a design modification to the V40™ and P.C.A.® femoral heads previously manufactured by Howmedica Inc. These femoral heads are available in a range of outer diameter sizes and offsets, and were intended to mate with femoral stems with a 5° 40' taper angle, and 2° 52' taper angle, respectively. These femoral heads were also intended to mate with acefabular components (bipolar and unipolar components, as well as one and two piece acetabular components) manufactured by Howmedica Inc. Since the merger of Howmedica Inc. with Osteonics Corp. (a wholly owned subsidiary of Stryker Corp.), it is desired that these femoral heads should be compatible with acetabular components (bipolar, unipolar, and one and two piece acetabular cups) previously manufactured by Osteonics Corp. In order for this to be accomplished, there must be a design modification made to the femoral heads: a small chamfer must be added to the base of the femoral head to assure that there will not be impingement on the Osteonics bipolar component. It is also desired that femoral heads manufactured by Osteonics be compatible with Howmedica acetabular components. No design change is required to allow Osteonics femoral heads to mate with Howmedica acetabular cups, however, a labeling change will be made to address the compatibility of these components. The modified components, the V40™ and P.C.A.® femoral heads, are substantially equivalent to the predicate devices which were cleared for marketing via the 510k) process. The V40™ and P.C.A.® femoral heads are manufactured from wrought cobalt-chromium-molybdenum (Vitallium®) alloy which conforms to ASTM F-1537.

AI/ML Overview

This document is a 510(k) summary for a design modification to existing femoral heads for hip replacement. It outlines the device, its intended use, and the regulatory classification. However, it does not contain information about acceptance criteria or a study proving device performance against such criteria.

The document describes a design modification (adding a chamfer to the base of the femoral head) to ensure compatibility with another company's acetabular components after a merger. It states that the modified components are "substantially equivalent" to predicate devices, meaning they meet the same performance and safety standards as previously cleared devices. This substantial equivalence is based on the device's material (wrought cobalt-chromium-molybdenum alloy conforming to ASTM F-1537) and its identical intended use to the predicate devices.

Therefore, I cannot provide the requested information from this document. The request specifically asks for a table of acceptance criteria and reported device performance from a study, along with details about sample sizes, ground truth, experts, and adjudication methods. This type of detailed performance data and study design information is not present in this 510(k) summary. This document primarily focuses on regulatory approval based on demonstrating substantial equivalence, not on presenting a detailed performance study against specific acceptance criteria.

Summary

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NOV 1 6 1999

Special 510(k) Summary - Device ModificationSummary of Safety and Effectiveness for theHowmedica Osteonics Femoral Heads
Proprietary Name:	Howmedica Osteonics Femoral Heads
Common Name:	Modular Femoral Head
Classification Name and Reference:	Hip joint metal/polymer semi-constrainedcemented prosthesis, 21 CFR §888.3350Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis,21 CFR §888.3358
Proposed Regulatory Class:	Class II
Device Product Code:	OR (87) JDIOR (87) LWJ
For Information contact:	Nancy J. RiederRutherford Regulatory AffairsHowmedica Osteonics Corp.359 Veterans BoulevardRutherford, New Jersey 07070-2584Phone: [phone]Fax: [phone]E-mail: [e-mail]

This Special 510(k) submission is intended to address a design modification to the V40™ and P.C.A.® femoral heads previously manufactured by Howmedica Inc. These femoral heads are available in a range of outer diameter sizes and offsets, and were intended to mate with femoral stems with a 5° 40' taper angle, and 2° 52' taper angle, respectively. These femoral heads were also intended to mate with acefabular components (bipolar and unipolar components, as well as one and two piece acetabular components) manufactured by Howmedica Inc. Since the merger of Howmedica Inc. with Osteonics Corp. (a wholly owned subsidiary of Stryker Corp.), it is desired that these femoral heads should be compatible with acetabular components (bipolar, unipolar, and one and two piece acetabular cups) previously manufactured by Osteonics Corp. In order for this to be accomplished, there must be a design modification made to the femoral heads: a small chamfer must be added to the base of the femoral head to assure that there will not be impingement on the Osteonics bipolar component.

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It is also desired that femoral heads manufactured by Osteonics be compatible with Howmedica acetabular components. No design change is required to allow Osteonics femoral heads to mate with Howmedica acetabular cups, however, a labeling change will be made to address the compatibility of these components.

The modified components, the V40™ and P.C.A.® femoral heads, are substantially equivalent to the predicate devices which were cleared for marketing via the 510k) process. The V40™ and P.C.A.® femoral heads are manufactured from wrought cobalt-chromium-molybdenum (Vitallium®) alloy which conforms to ASTM F-1537. The intended use of the subject V40™ and P.C.A.® femoral heads is identical to that of the predicate V40™ and P.C.A.® femoral heads.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 6 1999

Ms. Nancy J. Rieder Rutherford Regulatory Affairs Howmedica Osteonics Corporation 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

Re: K993601 Trade Name: Howmedica Osteonics Femoral Heads Requlatory Class: II Product Codes: JDI, LWJ, and KWY Dated: October 22, 1999 Received: October 25, 1999

Dear Ms. Rieder:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to ene regaración onereida, "Mabbanding" J "Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K 993601

Device Name: Howmedica Osteonics Femoral Heads

Indications for Use:

These devices are modular components of a total hip system. These femoral heads are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.

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• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • -Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

OR

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

510(k) Nun

Regulation Number and Section

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented 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 a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.