The indications for the use of the Osteonics® Restoration HA 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.

Additional Indication for Osteonics Head/Neck Stems:

Clinical circumstances which require an altered femoral resection level due to a proximal . fracture, bone loss or calcar lysis.

Device Description

The Osteonics® Restoration HA Hip Stems are currently marketed devices that are being modified. The modification involves shortening the trunnion and reducing the diameter of the stem neck. Additionally, the neck length of each stem will be reduced by 5mm to better accommodate patient physiology. All other aspects of the Osteonics® Restoration HA Hip Stems will remain unchanged, with the exception of one feature on the longest stem (255mm). This stem currently features a distal tri-slot, which will be eliminated on the new version of the stem.

AI/ML Overview

This document is a 510(k) premarket notification for a modified medical device, the Osteonics® Restoration HA Hip Stems. It primarily addresses the substantial equivalence of the modified device to a previously cleared predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in the typical sense of a clinical trial or performance study against pre-defined metrics.

Therefore, many of the requested items (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, specific ground truth types) are not applicable or cannot be extracted from this type of regulatory submission. The document focuses on mechanical testing to establish substantial equivalence based on engineering properties.

Here's an analysis of what information can be gleaned from the document regarding acceptance criteria and performance, as well as the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Equivalence: Fatigue strength equivalent to predicate hip stems.	"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."
Indications for Use Equivalence: Maintain existing approved indications.	The modified device's intended use and indications are listed and are consistent with legally marketed Osteonics femoral components.
Material Equivalence: Made from specified titanium alloy.	"The Osteonics® Restoration HA Hip Stems are manufactured from titanium alloy (ASTM F-620-96)."

Limitations to Acceptance Criteria:
The document does not explicitly state quantitative "acceptance criteria" (e.g., "fatigue life must exceed X cycles at Y load with a 95% confidence interval"). Rather, it states the goal of the mechanical testing was to demonstrate "substantial equivalence" in fatigue strength. The specific numerical thresholds or comparative data from the mechanical testing are not provided in this summary.

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

Sample Size for Test Set: Not specified. The document refers to "mechanical testing," which typically involves a small number of physical samples for engineering tests. It is not a clinical study involving patients.
Data Provenance: Not applicable in the sense of patient data. The "data" refers to results from laboratory-based mechanical tests.

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

Not applicable. Ground truth, in this context, would be the precisely measured mechanical properties. These are determined by engineering testing processes, not typically by expert consensus in the way clinical images or diagnoses are.

4. Adjudication Method for the Test Set

Not applicable. Mechanical test results are objective measurements based on standardized testing protocols, not subjective assessments requiring adjudication.

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

No. This is a submission for a mechanical implant device, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

Not applicable. This is a medical implant, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the mechanical testing: The "ground truth" would be the actual mechanical properties (e.g., ultimate tensile strength, yield strength, fatigue life) determined through standardized laboratory testing methods. These are objective engineering measurements.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an engineering test for a physical implant.

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

Not applicable.

Summary of the Study Discussed (Mechanical Testing for Substantial Equivalence):

The document describes a special 510(k) submission for modifications to an existing hip stem. The primary "study" mentioned is mechanical testing to demonstrate substantial equivalence in fatigue strength between the modified device and its predicate.

Purpose: To demonstrate that minor design modifications (shortened trunnion, reduced neck diameter, reduced neck length, removal of a distal tri-slot on one specific stem) do not adversely affect the mechanical performance, specifically fatigue strength, compared to the previously cleared predicate device.
Methodology: "Mechanical testing has been performed." The specific tests, number of samples, or detailed results are not included in this summary. These details would be contained in the full 510(k) submission but are not publicly detailed in this letter or summary.
Conclusion: The testing led to a determination of substantial equivalence, allowing the device to be marketed under the same indications, with the critical limitation that no new biological attachment or enhanced performance claims can be made beyond mechanical interlock.

This document is a regulatory communication, not a research paper, and therefore provides only a high-level summary of the safety and effectiveness information.

Summary

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Image /page/0/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The text is presented on a white background. The words are stacked on top of each other, with "Public Health" on the first line and "Service" on the second line.

Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 1988

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

K983870 Re: Osteonics Restoration HA Hip Stem Trade Name: Requlatory Class: II Product Code: MEH Dated: October 28, 1998 Received: November 2, 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 You may, therefore, composition detailed in this application. 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 misbrandinq and adulteration.

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Page 2 - Ms. Kate Sutton

You may market your device under the above limitations as a rou may market your devices would be considered not substantially equivalent to a legally marketed predicate Substantially equivalens of a intended uses and/or claims of device in rabbits and other intended uses or claims may cause the device to be classified into Class III under may cause the defice of Class III devices are required to beceion sioned premarket approval (PMA) application prior to marketing.

Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes 895. compliance with the current Good Manufacturing Practice compliation with the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part (QS) for Medical beviews. Sciences (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 Register. Please note: this your device in choremarket notification submission follow affect any obligation you might have under sections 531 arrest any obility of the Act for devices under the Electronic chrough 342 or the not on provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as Inis fected will affer your of your of the motification immediately. An FDA finding of substantial equivalence of your device to a rdi rimany in the may be results in a classification fegarly markive 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 compriation and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ene 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 - Ms. Kate Sutton

obtained from the Division of Small Manufacturers Assistance obeathed from chomber (800) 638-2041 or (301) 443-6597 or at at fes coll free namber (s://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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510(k) Number (if known): K 983870

Device Name: Osteonics® Restoration HA Stems

Indications For Use:

The indications for the use of the Osteonics® Restoration HA 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.

Additional Indication for Osteonics Head/Neck Stems:

Clinical circumstances which require an altered femoral resection level due to a proximal . fracture, bone loss or calcar lysis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X(Per 21 CFR 801.109)	OR	Over-The-Counter Use ______(Optional Format 1-2-96)
	(Division Sign-Off)Division of General Restorative Devices
	510(k) Number K783870

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DEC - 2 1988

K983870

Special 510(k) - Device Modification Summary of Safety and Effectiveness for the Osteonics® Restoration HA Hip Stems

Submission Information
Name and Address of the Sponsorof the 510(k) Submission:	Osteonics Corporation59 Route 17Allendale, NJ 07401-1677
Contact Person:	Kate SuttonRegulatory Affairs Specialist
Date of Summary Preparation:	October 28, 1998
Device Identification
Proprietary Name:	Osteonics® Restoration HA Hip Stems
Common Name:	Hip Prosthesis
Classification Name and Reference:	Hip Joint, Metal/Ceramic/Polymer, Semi-Constrained, Cemented or Non-Porous Uncemented Prosthesis21 CFR §888.3353

Predicate Device Identification

The modified features of the Osteonics® Restoration HA Hip Stems are substantially equivalent to features of the following Osteonics predicate devices, which have been cleared for marketing via the 510(k) process:

· Osteonics® Restoration HA Hip Stems

Device Description

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Intended Use:

The Osteonics® Restoration HA Hip 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® Restoration HA Hip Stems are manufactured from titanium alloy (ASTM F-620-96). The indications for the Osteonics® Restoration HA Hip 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, theumatoid 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.

Additional Indication for Osteonics Head/Neck Stems:

Clinical circumstances which require an altered femoral resection level due to a proximal . fracture, bone loss, or calcar lysis.

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.

Statement of Technological Comparison:

All features of the Osteonics® Restoration HA Hip Stems will remain the same with the following exceptions: 1) The distal tri-slot on the longest stem will be eliminated, 2) the neck diameter on each stem will be slightly reduced and the neck length will be reduced by 5mm, and 3) the trunnion will be shortened slightly.

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.