The Osteonics® Extended Femoral Bearing Heads are intended for single use in patients requiring either a Total Hip Replacement or Hemi- or Bipolar Hip Replacement. The Osteonics® Extended Femoral Bearing Heads are designed to accommodate a patient population requiring extended offset provided by a plus 12.5mm or a plus 15mm femoral head option when used in conjunction with the Osteonics® Femoral Stems specified in this submission.

Indications:

For use as a Bipolar or Hemi-Hip Replacement:

Femoral head/neck fractures or non-unions.
Aseptic necrosis of the femoral head.
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Other considerations for use as a Bipolar or Hemi-Hip Replacement:

Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
Salvage of failed total hip arthroplasty.

For use as a Total Hip Replacement:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Device Description

The Osteonics® Extended Femoral Bearing Heads are ASTM F-799 Cobalt chromium alloy devices available in two female taper configurations, a Morse Taper and a European Taper (Osteonics` trade name "C-Taper"). The devices are spherical in design and are available in 22, 26, 28, and 32mm diameters with +12.5mm and +15mm neck extensions. The outer surface of the Osteonics® Extended Femoral Bearing Heads are highly polished and are available both with and without nitrogen ion surface treatment.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Summary for the Osteonics® Extended Femoral Bearing Head. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting performance data from a new study designed to meet specific acceptance criteria of the device itself.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets these criteria, sample sizes, expert involvement, and ground truth establishment is not available in this document.

Here's a breakdown of why the requested information cannot be extracted:

No Acceptance Criteria or Performance Study: The document explicitly states under "Performance Data": "The comparison of the Osteonics® Extended Femoral Bearing Head to predicate systems which have been determined to be substantially equivalent through 510(k) premarket notifications demonstrates that no additional performance data are necessary." This indicates that no new performance tests or studies were conducted for this submission with specific acceptance criteria that the device was tested against.
Substantial Equivalence, Not De Novo Performance: The entire submission relies on establishing "substantial equivalence" to already legally marketed predicate devices (Osteonics® Morse Taper Heads, Osteonics® C-Taper Heads, and DePuy Articule-Eze® Total Hip Balls). This means the device is considered safe and effective because its design, materials, and intended use are similar to products already on the market, not because it met new, independently defined performance metrics through a dedicated study.

In summary, the document does not contain the information needed to fill out the requested table or answer the specific questions about a performance study, acceptance criteria, sample sizes, or ground truth establishment.

Summary

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OCT 21 1998

R982936

510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® Extended Femoral Bearing Head

Submission Information:

Name and Address of the Sponsor of the 510(k) Submission:

Contact Person:

Date of Summary Preparation:

Device Identification

Proprietary Name:

Common Name:

Classification Name/Reference:

Osteonics Corporation 59 Route 17 Allendale NJ 07401-1677

Marybeth Naughton Regulatory Affairs Team Member

August 20, 1998

Osteonics® Extended Femoral Bearing Head

Modular Femoral Bearing Head

Hip Joint, Metal/Polymer, Semi-constrained, Cemented Prosthesis 21 CFR §888.3350

Predicate Device Identification:

The Osteonics® Extended Femoral Bearing Heads are substantially equivalent to the following predicate devices: The Osteonics® Morse Taper Heads, the Osteonics® C-Taper Heads, and the DePuy Articule-Eze® Total Hip Balls.

Description of Devices:

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Intended Use:

The Osteonics® Extended Femoral Bearing Heads are indicated for single-use in patients requiring either a Total Hip Replacement or a Hemi- or Bipolar Hip Replacement. The Osteonics® Extended Femoral Bearing Heads are intended to be used with a specific listing of Osteonics® femoral stems identified in Attachment 1 and are designed to accommodate a patient population requiring the extended offset in order to restore ligamentous balance.

Statement of Technological Comparison:

The design, materials, and intended use of the Osteonics® Extended Femoral Bearing Heads are substantially equivalent in design, materials and intended use to the predicate Osteonics® Morse Taper Heads, the Osteonics® C-Taper Heads and the DePuy Articule-Eze® Total Hip Balls.

Performance Data:

The comparison of the Osteonics® Extended Femoral Bearing Head to predicate systems which have been determined to be substantially equivalent through 510(k) premarket notifications demonstrates that no additional performance data are necessary.

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ATTACHMENT 1 (Page 1)

Osteonics® Femoral Stems to be used with Osteonics® Extended Femoral Bearing Heads

Catalog Number	Description
S-1162-HFXX	CoCr Alloy, Plasma Sprayed, Omnifit, Collared, Normalized, Morse Taper Trunnion
1003-xxxx	CoCr Alloy, Satin Finish, Omnifit, Collarless, Normalized, Morse Taper Trunnion
1004-xxxx	CoCr Alloy, Satin Finish, Omnifit, Collared, Normalized, Morse Taper Trunnion
1005-xxxx	Ti6Al-4V Alloy, Satin Finish, Omnifit, Collarless, Normalized, Morse Taper Trunnion
1006-xxxx	Ti6Al-4V Alloy, Satin Finish, Omnifit, Collared, Normalized, Morse Taper Trunnion
1012-xxxx	Ti6Al-4V Alloy, Satin Finish, Omnifit, Collared, Normalized, Morse Taper Trunnion
1017-xxxx	Ti6Al-4V Alloy, HA Coated, Omnifit, Collarless, Normalized, Morse Taper Trunnion
1044-xxxx	CoCr Alloy, Satin Finish, Omnifit, Collared, Normalized, Morse Taper Trunnion
1045-xxxx	Ti6Al-4V Alloy, Satin Finish, Omnifit, Collarless, Normalized, Morse Taper Trunnion
1046-xxxx	Ti6Al-4V Alloy, Satin Finish, Omnifit, Collared, Normalized, Morse Taper Trunnion
1055-xxxx	Ti6Al-4V Alloy, HA Coated, Omnifit, Collared, Normalized, Morse Taper Trunnion
1092-xxxx	Ti6Al-4V Alloy, HA Coated, Omnifit, Collarless, Normalized, Morse Taper Trunnion
1093-xxxx	Ti6Al-4V Alloy, HA Coated, Omnifit, Collared, Normalized, Morse Taper Trunnion
1094-xxxx	Ti6Al-4V Alloy, HA Coated, Omnifit, Collarless, Normalized, Morse Taper Trunnion
21-xxxx	CoCr Alloy, Satin Finish, Omnifit, Collared, Smooth, Morse Taper Trunnion
6005-xxxx	Ti6Al-4V Alloy, Satin Finish, Omnifit, Collarless, Normalized, C-Taper Trunnion
6006-xxxx	Ti6Al-4V Alloy, Satin Finish, Omnifit, Collared, Normalized, C-Taper Trunnion
6010-xxxx	CoCr Alloy, Satin Finish, Omnifit, Collared, Normalized, C-Taper Trunnion
6017-xxxx	Ti6Al-4V Alloy, HA Coated, Omnifit, Collarless, Normalized, C-Taper Trunnion
6025-xxxx	Ti6Al-4V Alloy, Satin Finish, Omnifit. Collarless, Normalized, C-Taper Trunnion
6026-xxxx	Ti6Al-4V Alloy, Satin Finish, Omnifit. Collared, Normalized, C-Taper Trunnion
6033-xxxx	CoCr Alloy. Satin Finish. Omnifit. Collarless. Normalized, C-Taper Trunnion
CatalogNumber	Description
6034-xxxx	CoCr Alloy, Satin Finish, Omnifit, Collared, Normalized, C-Taper Trunnion
6070-xxxx	CoCr Alloy, Grit Blasted, Omnifit, Collared, Smooth, C-Taper Trunnion
6072-xxxx	CoCr Alloy, Rough Finish, Omnifit, Collared, Smooth, C-Taper Trunnion
6079-xxxx	CoCr Alloy, Satin Finish, Omnifit, Collared, Smooth, C-Taper Trunnion
6088-xxxx	CoCr Alloy, Satin Finish, Omnifit, Collared, Normalized, C-Taper Trunnion
S0853-HF0x	CoCr Alloy, Grit Blasted, Omnifit, Collarless, Smooth C-Taper Trunnion
S1003-xxxx	CoCr Alloy, Plasma Sprayed, Omnifit, Collarless, Normalized, Morse Taper Trunnion
S1003-xxxx-A	CoCr Alloy, Satin Finish, Omnifit, Collarless, Normalized, Morse Taper Trunnion
S1003-xxxx-C	CoCr Alloy, Satin Finish, Omnifit, Collarless, Normalized, Morse Taper Trunnion
S1003-xxxx-D	CoCr Alloy, Satin Finish, Omnifit, Collarless, Normalized. Morse Taper Trunnion
S1012-xxxx-A	Ti6Al-4V Alloy, Satin Finish, Omnifit, Collarless, Normalized, Morse Taper Trunnion
S1149-xxxx	Ti6Al-4V Alloy, HA Coated, Omnifit, Collared, Normalized, Morse Taper Trunnion
S1296-HF0x	Ti6Al-4V Alloy, Satin Finish, Omnifit, Collared, Normalized, Morse Taper Trunnion
S1414-xxxx	CoCr Alloy, Grit Blasted, Omnifit, Collared, Smooth, C-Taper Trunnion
S1456-xxxx	Ti6Al-4V Alloy, Satin Finish, Omnifit, Collared, Normalized, Morse Taper Trunnion
S1462-HF0x	CoCr Alloy, Grit Blasted, Omnifit, Collared, Smooth, C-Taper Trunnion
S1966-xxxx	CoCr Alloy, Satin Finish, Omnifit, Collarless, Normalized, C-Taper Trunnion
S21-xxxx	CoCr Alloy, Satin Finish, Omnifit, Collared, Smooth, Morse Taper Trunnion
S21-xxxx-A	CoCr Alloy, Satin Finish, Omnifit, Collared, Smooth, Morse Taper Trunnion
S21-xxxx-B	CoCr Alloy, Satin Finish, Omnifit, Collared, Smooth, Morse Taper Trunnion
S21-xxxx-C	CoCr Alloy, Satin Finish, Omnifit, Collarless, Smooth, Morse Taper Trunnion
S2591-xxxx	CoCr Alloy, Satin Finish, Omnifit, Collared, Normalized, C-Taper Trunnion

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ATTACHMENT 1 (PAGE 2)

Osteonics® Femoral Stems to be used with Osteonics® Extended Femoral Bearing Heads

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

Ms. Elizabeth A. Staub Director, Quality Assurance and Regulatory Affairs Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey

Re: K982936 Osteonics® Extended Femoral Bearing Head Trade Name: Regulatory Class: İI Product Code: LWJ Dated: August 20, 1998 Auqust 21, 1998 Received:

Dear Ms. Staub:

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 The general controls provisions of the Act 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 regulation may result in regulatory In addition, FDA may publish further announcements action. 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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Page 2 - Ms. Elizabeth A. Staub

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Whitton, Ph.D.

~ Celia M. Witten, Ph.D., M.D. 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 9829 36

Device Name: Osteonics® Extended Femoral Bearing Head

Indications For Use:

Indications:

For use as a Bipolar or Hemi-Hip Replacement:

· Femoral head/neck fractures or non-unions.
Aseptic necrosis of the femoral head. ●
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal . acetabular involvement or distortion.

Other considerations for use as a Bipolar or Hemi-Hip Replacement:

· Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
Salvage of failed total hip arthroplasty. .

For use as a Total Hip Replacement:

· Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive ● techniques are less likely to achieve satisfactory results.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)

OROver-The-Counter Use No
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K482936

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.