The subject devices are single use devices. They are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper* hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylene bearing surfaces.

Indications for Use as a Bipolar

Femoral head/neck fractures or non-unions,
Aseptic necrosis of the femoral head,
Osteo-, theumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Pathological conditions or age considerations that indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum,
Salvage of failed total hip arthroplasty

Indications for Use as a Total Hip:

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,
Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.

Device Description

The subject Zirconia-Toughened-Alumina (ZTA) Ceramic Femoral Heads feature:

Biolox® Delta material: this material is a composite of approximately 75% Alumina ceramic, with the balance consisting of zirconium oxide, chromium oxide, and other oxides,
A C-Taper bore to mate with C-Taper* stems made from Titanium or CoCr alloys,
Sizes:
- 28mm diameter with neck lengths of -2.5mm, +0mm, +2.5mm, +5mm,
- 32mm diameter with neck lengths of -2.5mm, +0mm, +2.5mm, +5mm,
- 36mm diameter with neck lengths of –2.5mm. +0mm. +2.5mm. +5mm.

AI/ML Overview

The provided text is for a 510(k) Summary of Safety and Effectiveness for a medical device (Zirconia-Toughened-Alumina Ceramic Femoral Heads), not an AI/ML device. Therefore, the concepts of acceptance criteria, test set, ground truth, expert adjudication, MRMC studies, or training sets as they relate to AI/ML performance metrics are not applicable to this document.

The document discusses the substantial equivalence of a new device to predicate devices based on:

Intended Use: The new device shares identical indications for use but has a slightly broader compatibility with hip stems (CoCr or Titanium alloys).
Design: Same basic design, C-Taper bore, and outer diameters as predicate devices, with neck length options falling within the range of cleared predicate devices.
Material: Made from ZTA ceramic, similar to one of the cited predicate devices.
Performance Data: Mechanical testing demonstrated that the new device's mechanical properties were "substantially equivalent" to the predicate devices.

The "acceptance criteria" in this context are implicitly that the new device performs mechanically at least as well as the predicate devices, and that its design, material, and intended use are sufficiently similar to warrant substantial equivalence without requiring new clinical studies. The study proving this involves mechanical testing, not the kind of studies you would conduct for an AI/ML diagnostic device.

Therefore, I cannot fill out the requested table or answer the questions related to AI/ML device performance for this document.

Summary

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FEB 1 1 2005

K041940

510(k) Summary of Safety and Effectiveness for the ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX® DELTA) CERAMIC FEMORAL HEADS

Proprietary Name:	Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox® Delta) Ceramic Femoral Heads
Common Name:	Artificial Femoral Head Component
Classification Name and Reference:	Hip Joint, Metal/Ceramic/Polymer, Semi-Constrained, Cemented or Nonporous UncementedProsthesis, 21 CFR §888.3353
Proposed Regulatory Class:	Class II
Device Product Code:	87 LZO
Official Contact:	Terry Sheridan PowellRegulatory Affairs Team (Consultant)Howmedica Osteonics Corp.325 Corporate DriveMahwah, New Jersey 07430Phone: (201) 831-5493Fax: (201) 831-6038E-Mail: Terry.Powell@stryker.com)
Date Summary Prepared:	December 1, 2004

Predicate Devices

The predicate devices cited in this 510(k) application are the Osteonics® Alumina C-Taper Heads cleared under K971409, K991952, and K003391, and the competitive ceramic heads cleared under K031803.

Device Description

The subject Zirconia-Toughened-Alumina (ZTA) Ceramic Femoral Heads feature:

. Biolox® Delta material: this material is a composite of approximately 75% Alumina ceramic, with the balance consisting of zirconium oxide, chromium oxide, and other oxides,

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A C-Taper bore to mate with C-Taper* stems made from Titanium or CoCr alloys, .
a Sizes:
- 0 28mm diameter with neck lengths of -2.5mm, +0mm, +2.5mm, +5mm,
- 32mm diameter with neck lengths of -2.5mm, +0mm, +2.5mm, +5mm,
- 36mm diameter with neck lengths of –2.5mm. +0mm. +2.5mm. +5mm.

Intended Use

The subject devices are single use devices. They are intended for mechanical fixation to their mating hip stems, and can be used in cementless hip arthroplasty procedures. The subject devices are single use devices. They can be used with all Howmedica Osteonics C-Taper* hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylene bearing surfaces.

Indications for Use as a Bipolar

Femoral head/neck fractures or non-unions. .
l Aseptic necrosis of the femoral head.
u Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion,
. Pathological conditions or age considerations that indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum,
에 Salvage of failed total hip arthroplasty.

Indications for Use as a Total Hip:

Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid I 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.
. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.

Substantial Equivalence:

Intended Use:

The subject devices share the identical indications for use as the cited predicate Howmedica Osteonics devices. The intended use for the predicate Howmedica Osteonics devices states that they can be used only with C-Taper hip stems made from Titanium alloy. The subject devices, however, can be used with C-Taper* hip stems made from CoCr or Titanium alloys. This is because the subject devices, made from ZTA ceramic, are stronger.

Design:

The subject devices feature the same design as the predicate Howmedica Osteonics devices. They feature the same C-Taper bore, and the same availability in 28mm, 32mm, and 36mm outer

* The term "C-Taper" includes both the original C-Taper design, and the modified C-Taper design first introduced on the hip stems found Substantially Equivalent via K982032.

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diameters. The subject devices feature neck length options of -2.5mm, +0mm, +2.5mm, and +5mm (while the predicate devices feature neck length options of -5mm, -2.5mm, +0mm, and +5mm). The subject devices do not feature a new worst-case neck length option-all neck length options fall within the range of neck lengths already cleared for the predicate Howmedica Osteonics devices.

Material:

The subject devices are manufactured from ZTA ceramic material. One of the cited predicate devices is also manufactured from ZTA ceramic material.

Performance Data:

Mechanical testing demonstrated that the subject devices' mechanical properties were substantially equivalent to the predicate devices' mechanical properties.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, arranged in a layered or overlapping manner.

FEB 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430

Re: K041940

Trade/Device Name: Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox® Delta) Ceramic Femoral Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: January 20, 2005 Received: January 21, 2005

Dear Ms. Ariemma:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becare in in it is substantially equivalent [(for the indications for use stated in the enclosure)] to legally marketed predicate devices marketed in interstate for associated in the energy, 1976, the enactment date of the Medical Device Amendments or to commerce proc to May 20, 1978, is ecordance with the provisions of the Federal Food, Drug, de rices that have boon require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainer the act include requirements for annual registration, listing of devices, controls provisions or the received son prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r tease be devised had i termination that your device complies with other requirements of the Act that I Dri has made a active and regulations administered by other Federal agencies. You must or any I edital the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quilty by store (sions (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Karen Ariemma

This letter will allow you to continue marketing your device as described in your Section 510(k) I mb lotter will and wy of substantial equivalence of your device of your device to a legally premated notificated 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), please If you desire spocents acrioliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other golferal milermational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K041940

Device Name: ZTA Ceramic Femoral Heads________________________________________________________________________________________________________________________________________

Indications for Use:

Indications for Use as a Bipolar

Femoral head/neck fractures or non-unions, 해
. Aseptic necrosis of the femoral head,
Osteo-, theumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Pathological conditions or age considerations that indicate a more conservative I acetabular procedure and an avoidance of the use of bone cement in the acetabulum,
내 Salvage of failed total hip arthroplasty

Indications for Use as a Total Hip:

Painful disabling joint disease of the hip resulting from: degenerative arthritis, 6 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 내 techniques are less likely to achieve satisfactory results,
Where bone stock is of poor quality or is inadequate for other reconstructive . techniques as indicated by deficiencies in the acetabulum.

The term "C-Taper" includes both the original C-Taper design, and the modified C-Taper design first introduced on the hip stems found Substantially Equivalent via K982032

Prescription Use X(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

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510(k) Number. K041940

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.