K Number

Device Name

Manufacturer

OSTEONICS CORP.

Date Cleared

1997-07-16

(83 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

The Osteonics® Anteverted Neck Hip Stems are intented for single use in patients requiring either a bipolar hip replacement or a total hip replacement. The Osteonics® Anteverted Neck Hip Stems are intended in a cementless application. These devices feature an Osteonics® C-Taper trunnion, and are therefore compatible with any Osteonics® component which features the mating Osteonics® C-Taper geomerry. The Osteonics® Anteverted Neck Hip Stems, when used with any commercially available Osteonics® C-Taper femoral bearing head, may be used with any commercially available Osteonics® acetabular component. The indications for the use of the Osteonics® Anteverted Neck Hip Stems, in keeping with those of other legally marketed Class II hip stems, are as follows:

For use as a Bipolar 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:

Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
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 wascular 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® Anteverted Neck Hip Stems are fabricated from forged ASTM F-620 Titanium 6AI-4V ELI alloy, employ a standard satin finish, and have a surface coating of arc deposited commercially pure (CP) Titanium (per ASTM F-67) on the proximal third of the femoral stem. The basic design characteristics of the Osteonics® Anteverted Neck Hip Stems include proportional stem sizes, maximized projected proximal anterior and posterior normalizations, and an Osteonics® C-Taper trunnion. A reduced anterior/posterior collar is present to resist potential subsidence of the stem. The Osteonics® Anteverted Neck Hip Stems feature a rounded configuration for the length of the stem's lateral aspect and a cylindrical distal cross-section, thereby providing physiological fit in the distal as well as proximal regions of the femur. The subject hip stems are available in three proportional sizes, with distal diameters and stem lengths proportionate to the stem's size, and are available in both left and right configurations. Each hip stem features a 15° anteverted neck angle to satisfy anatomic considerations and physician need.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, the Osteonics® Anteverted Neck Hip Stem. 510(k) applications are used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. They typically do not involve the kind of rigorous clinical studies with specific acceptance criteria and detailed performance reporting that would be present for novel devices or those undergoing PMA (Premarket Approval). The information provided in this 510(k) focuses on demonstrating equivalence through design, materials, and technological comparison.

Therefore, many of the requested categories related to clinical study performance, acceptance criteria, expert ground truth, and statistical analysis for AI devices are not applicable to this 510(k) submission. This submission is for a medical implant (hip stem), not an AI/software device, and precedes modern regulatory requirements for AI performance evaluation.

Here's a breakdown of the applicable information based on the provided text, with clarifications where categories are not relevant:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Demonstrated Equivalence Basis)	Reported Device Performance (Claimed Equivalence)
Materials: ASTM F-620 Titanium 6AI-4V ELI alloy, CP Titanium coating (ASTM F-67)	Device fabricated from specified materials.
Indications & Intended Use: Consistent with predicate devices.	Device listed the same indications as predicate devices for bipolar and total hip replacement.
Surgical Techniques: Compatible with standard surgical techniques.	Implied to be consistent with predicate devices.
Basic Design Features: Proportional stem sizes, maximized proximal anterior/posterior normalizations, C-Taper trunnion, reduced A/P collar, rounded configuration for lateral aspect, cylindrical distal cross-section, 15° anteverted neck angle.	Device incorporates these specific design features mentioned.
Basic Manufacturing Methods: Consistent with predicate devices.	Implied to be consistent with predicate devices.
Performance Testing (Mechanical): Demonstrate no significant difference between components and predicate designs.	"Applicable performance testing demonstrates that no significant difference exists between these components and their predicate designs." (Specific test results or criteria are not detailed in this summary, which is typical for a 510(k) summary).

Explanation: In a 510(k), "acceptance criteria" for the device itself are more about demonstrating substantial equivalence to a predicate device rather than achieving specific quantitative performance metrics in a clinical trial. The "reported device performance" is the assertion of that equivalence based on the provided comparisons and "applicable performance testing" which were likely mechanical or bench testing.

2. Sample sized used for the test set and the data provenance

Sample Size: Not applicable. This 510(k) for a hip stem does not describe a clinical "test set" or human subject data in the way an AI study would. The equivalence is based on engineering, materials, and design specifications, likely supported by mechanical testing rather than a patient-based test set for performance evaluation in a clinical context within this summary.
Data Provenance: Not applicable. If any mechanical testing data was used, it would originate from engineering labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There was no "test set" for which ground truth was established by medical experts for performance evaluation in the context of this 510(k) summary. The ground truth for device design and safety would be based on engineering standards and regulatory requirements.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring expert adjudication is described in this 510(k) summary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a passive medical implant (hip stem), not an AI system. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a passive medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for clinical performance. The "ground truth" in the context of this 510(k) is the established safety and effectiveness of the predicate devices, as well as adherence to relevant material standards (e.g., ASTM F-620, ASTM F-67) and engineering principles for mechanical integrity.

8. The sample size for the training set

Not applicable. This 510(k) is for a medical implant, not an AI system. There is no "training set" in this context.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth establishment for one.

Summary

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K9 7 1497

Osteonics" Anteverted Neck Hip Stem

510(k) Premarket Notification

510(K) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEONICS® ANTEVERTED NECK HIP STEM

JUL 16 1997

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

Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677 201-825-4900

Donna S. Wilson Regulatory Affairs Specialist

Contact Person:

Date Summary Prepared:

Device Identification Proprietary Name:

Common Name:

Classification Name and Reference:

April 23, 1997

Osteonics® Anteverted Neck Hip Stem

Hip Prosthesis

Hip Joint, Metal/Polymer/Metal, Semi-Constrained, Porous Coated, Uncemented Prosthesis; 21 CFR §888.3358

Predicate Device Identification

The Osteonics® Anteverted Neck Hip Stems are substantially equivalent to the Osteonics® Omnifit® AD Hip Stem Series, and the Zimmer® Anatomic Hip Prosthesis (including CP, BR, and LS versions).

Device Description

{1}------------------------------------------------

Osteonics" Anteverted Neck Hip Stem

stem lengths proportionate to the stem's size, and are available in both left and right configurations. Each hip stem features a 15° anteverted neck angle to satisfy anatomic considerations and physician need.

Intended Use

The Osteonics® Anteverted Neck Hip Stem is intended for single use in patients requiring either a bipolar hip replacement or a total hip replacement. The Osteonics® Anteverted Neck Hip Stem is intended to be implanted in a cementless applications for the use of the use of the Osteonics® Anteverted Neck Hip Stem, in keeping with those of other legally marketed Class II hip stems, are as follows:

For use as a Bipolar 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:

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

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.

Statement of Technological Comparison

The Osteonics® Anteverted Neck Hip Stems share the same materials, indications and intended use, surgical techniques, basic design features, and basic manufacturing methods of their predicate devices. Applicable performance testing demonstrates that no significant difference exists between these components and their predicate designs.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Robert A. Koch, J.D. Director, Regulatory/Legal Affairs Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

JUL 1 6 1997

K971497 Re : Osteonics® Anteverted Neck Hip Stem Regulatory Class: II Product Codes: LZO, LPH, KWY Dated: April 23, 1997 Received: April 24, 1997

Dear Mr. Koch:

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 and the following limitation that the package insert must reflect that the C-taper Zirconia Ceramic Femoral Heads are to be used only with Ti6Al4V alloy hip stems with the C-taper dimensions (5°39′22″) trunnions.

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.

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Page 2 - Robert A. Koch, J.D.

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 Requlations, 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 Requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 diaqnostic 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

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Page 3 - Robert A. Koch, J.D.

obtained from the Division of Small Manufacturers Assistance obcathed from che birder (800) 638-2041 or (301) 443-6597 or at at Its Coll Free namber (s://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D. M.D.

Cella 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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510(k) Number (if known): K 971497

Device Name: Osteonics® Anteverted Neck Hip Stem

Indications For Use:

For use as a Bipolar 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:

Pathological conditions or age considerations which indicate a more conservative acetabular . procedure and an avoidance of the use of bone cement in the acetabulum.
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 wascular 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)

	(Division Sign-Off) Division of General Restorative Devices 510(k) Number	K97149
--	-------------------------------------------------------------------------------------------------------------------------	--------

Prescription Use	X (Per 21 CFR 801.109)	OR	Over-The-Counter Use ____ (Optional Format 1-2-96)
------------------	------------------------	----	----------------------------------------------------

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.