The indications for the use of the Osteonics® C-Tapered Titanium Stems , in keeping with those of other legally marketed Osteonics femoral components, 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.
. 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® C-Tapered Titanium Stems (Osteonics® Omnifit HA Hip Stem Series, Osteonics® Secur-Fit Hip Stem Series, Osteonics® Primary Secur-Fit Plus HipStem Series) are currently marketed devices that are being modification involves shortening the trunnion and reducing the diameter of the stem neck. All other aspects of the Osteonics® C-Tapered Titanium Stems will remain unchanged.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Osteonics® C-Tapered Titanium Stems:

Analysis of Acceptance Criteria and Performance Study for Osteonics® C-Tapered Titanium Stems

The provided document is a 510(k) submission for a device modification, not a comprehensive clinical study report for a new device. Therefore, the information typically associated with detailed acceptance criteria, test sets, ground truth establishment, and multi-reader studies for AI/ML devices is not present. This submission focuses on demonstrating substantial equivalence of a modified hip stem design to its predicate devices through mechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Performance Standard/Goal	Reported Device Performance (Modified Device)	Conclusion on Acceptance
Fatigue Strength	Substantial equivalence to predicate stem designs	Demonstrated substantial equivalence to predicate stem designs (through mechanical testing)	Met

Explanation of Criteria:
The core acceptance criterion for this 510(k) submission is that the modified device maintains substantial equivalence to its predicate devices, particularly concerning its fatigue strength. This is crucial because it indicates that the design changes (shortened trunnion, reduced neck diameter) do not negatively impact the mechanical integrity and longevity of the hip stem, which is a critical safety and effectiveness aspect for orthopedic implants.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a number of devices or "test set" in the context of a clinical trial. The testing appears to be mechanical in nature.
Data Provenance: The nature of mechanical testing usually involves engineered samples or actual device prototypes. No mention of human patient data, retrospective, or prospective studies in this context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. Ground truth in this context is the outcome of mechanical fatigue testing, which is determined by engineering standards and measurements, not expert human interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. As mechanical tests are objective measurements, there's no "adjudication" between multiple interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) study was performed. This document pertains to a physical medical device (hip stem) and its mechanical performance, not a diagnostic or AI-assisted interpretation device that would involve human readers.

6. Standalone Performance Study (Algorithm Only)

No standalone (algorithm only) performance study was performed. This is not an AI/ML device. The "device" is a physical hip stem.

7. Type of Ground Truth Used

Mechanical Test Results (Fatigue Strength): The "ground truth" here is derived from standardized mechanical fatigue testing methods, typically aligned with ASTM (American Society for Testing and Materials) standards relevant to orthopedic implants (e.g., ASTM F-620 for titanium alloys, potentially other standards for fatigue testing of hip prostheses).

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device and therefore does not involve a "training set" in that sense. The design process for such a device involves engineering principles and potentially iterative physical prototyping and testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no concept of a "training set" or "ground truth" establishment for training in the context of this device type and submission. The design of the hip stem is based on established biomechanical principles and material science.

Summary:

This 510(k) submission for the Osteonics® C-Tapered Titanium Stems is a regulatory filing for a device modification. The "acceptance criteria" and "study" described are focused on mechanical testing to demonstrate substantial equivalence in fatigue strength to previously cleared predicate devices. It is crucial to understand that the concepts of "test set," "ground truth," "experts," and "multi-reader studies" are primarily relevant to diagnostic devices, AI/ML algorithms, or clinical effectiveness studies in a way that doesn't directly apply to this type of device modification submission. The FDA's clearance is based on the finding of substantial equivalence through these engineering tests, implying that the modified design does not introduce new questions of safety or effectiveness compared to the predicate devices.

Summary

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JUL = 9 1998

K982032

Special 510(k) - Device Modification Summary of Safety and Effectiveness for the Osteonics® C-Tapered Titanium Stems

Submission Information

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

Contact Person:

Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677

Kate Sutton Regulatory Affairs Specialist

Date of Summary Preparation:

June 9, 1998

Device Identification

Proprietary Name:

Common Name:

Classification Name and Reference:

Osteonics® Omnifit® HA Hip Stem Series Osteonics® Secur-Fit™ HA Hip Stem Series Osteonics® Primary Secur-Fit™ Plus Hip Stem Series

Hip Prosthesis

Hip Joint, Metal/Ceramic/Polymer, Semi-Constrained. Cemented or Non-Porous Uncemented Prosthesis 21 CFR §888.3353

Predicate Device Identification

The modified features of the Osteonics® C-Tapered Titanium Stems (Osteonics® Omnifit HA Hip Stem Series, Osteonics® Secur-Fit HA Hip Stem Series® Primary Secur-Fit Plus HipStem Series) are substantially equivalent to features of the following Osteonics predicate devices, which has been cleared for marketing via the 510(k) process:

Osteonics® Omnifit® HA Hip Stem Series ●
Osteonics® Secur-Fit™ HA Hip Stem Series ●
Osteonics® Primary Secur-Fit™ Plus Hip Stem Series ●

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Device Description

Intended Use:

The Osteonics® C-Tapered Titanium Stems are single use components. They are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. The modified and predicate hip stems are intended to be used in conjunction with any commercially available Osteonics C-Taper femoral bearing head. For use as a total hip replacement, the modified and predicate stems may be used in conjunction with any legally marketed Osteonics acetabular component. The Osteonics® C-Tapered Titanium Stems are manufactured from titanium alloy (ASTM F-620-96). The indications for the Osteonics® C-Tapered Titanium Stems include the following:

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.
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.

Performance Data:

Mechanical testing has been performed to demonstrate the substantial equivalence of this Osteonics stem design to predicate stem designs in terms of its fatigue strength.

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Statement of Technological Comparison:

All features of the Osteonics® C-Tapered Titanium Stems (Osteonics® Omnifit HA Hip Stem Series, Osteonics® Secur-Fit Hip Stem Series, Osteonics® Primary Secur-Fit Plus HipStem Series) will remain the same with the exception of the trunnion, which will be shortened, and the neck diameter, which will be slightly reduced.

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Image /page/3/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads, representing health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 1998

Ms. Kate Sutton Requlatory Affairs Specialist Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K982032 Osteonics® C-Tapered Titanium Stems Regulatory Class: II Product Code: MEH Dated: June 8, 1998 Received: June 10, 1998

Dear Ms. Sutton:

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). This decision is based on consideration of the specific design of stem and coating composition detailed in this application. You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation:

You may not label or in any way promote these devices for "biological attachment, enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional press-fit.hip ____ prosthesis (i.e., mechanical interlock, only).

Additional limitations for more specific claims of safety and effectiveness may be forthcoming. Should additional limitations be applied you will be contacted in writing to inform you of the additional labeling limitations.

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 - Ms. Kate Sutton

You may market your device under the above limitations as class II devices. These devices would be considered not substantially equivalent to a legally marketed predicate device if labeled with other intended uses and/or claims of safety or effectiveness. Any other intended uses or claims may cause the device to be classified into Class III under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing.

Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800~to A substantially equivalent determination assumes 895. 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. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.

This letter will allow you to beqin 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 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 qeneral information on your responsibilities under the Act may be

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Page 3 - Ms. Kate Sutton

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,

C. Colby Mc. Whitney, Ph.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): K982032

Device Name: Osteonics® C-Tapered Titanium Stems

Indications For Use:

The indications for the use of the Osteonics® C-Tapered Titanium Stems , in keeping with those of other legally marketed Osteonics femoral components, 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.
. 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)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K962032

Prescription Use
(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.