The Osteonics +10 UniPolar Adaptor Sleeve is a single-use device and may be used with all appropriately selected, legally marketed Osteonics C-Taper Femoral Stems and with any size Osteonics legally marketed +0 mm Unipolar Endo Heads (Single-Piece Unipolar Design).

For Use as a 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:

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

Device Description

Osteonics +10 UniPolar Adaptor Sleeve is composed of cobalt chromium alloy and is designed to function with any size Osteonics +0 Unipolar Endo Head (Single-Piece Unipolar Design) and any Osteonics C-Taper Femoral Stem. The Osteonics +10 UniPolar Adaptor Sleeve is designed with both a male and a female C-taper. The female end receives the femoral stem and the male end engages the Endo Head.

The Osteonics +10 UniPolar Adaptor Sleeve is characterized by the following features:

A basic taper design.
A smooth exterior finish.
Constructed of material that has a long history of orthopedic use.

AI/ML Overview

This document is a 510(k) summary for a medical device (Osteonics® +10 UniPolar Adaptor Sleeve) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and providing a study that proves the device meets those criteria in the way a clinical performance study would for a diagnostic or AI-driven device.

Therefore, the requested information elements (acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable or available within this type of regulatory submission.

Here's why and what information is provided:

A table of acceptance criteria and the reported device performance:
- Not Applicable. This document is not a performance study report for a diagnostic or AI device. It's a regulatory submission for a mechanical implant. Performance is assessed through mechanical testing and comparison to predicate devices, not clinical metrics like sensitivity or specificity.
- The "performance" described relates to the design and material characteristics being consistent with existing, legally marketed devices.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. There is no "test set" in the context of clinical data for this type of device. The evaluation is based on mechanical testing and material compatibility. The document refers to "pre-clinical data incorporated by reference to prior submissions," which would involve mechanical testing on the device itself, not human subjects or biological samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. Ground truth, in the sense of expert consensus on diagnostic labels, is not relevant for this device. The "ground truth" for a mechanical implant is its physical and mechanical properties matching design specifications and established safety profiles.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical or diagnostic adjudication methods are relevant here.
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 is a mechanical implant, not an AI-driven diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable in the diagnostic sense. The "ground truth" for this device's safety and effectiveness relies on:
  - Material compatibility: Cobalt chromium alloy has a "long history of orthopedic use."
  - Design consistency: Basic taper design, smooth exterior finish, and dimensional specifications designed to accommodate other legally marketed components.
  - Comparison to predicate devices: The "substantial equivalence" framework relies on the new device sharing the same intended use, materials, and similar design features to devices already on the market. The "ground truth" is that these predicate devices are safe and effective.
The sample size for the training set:
- Not Applicable. No training set exists as this is not an AI/ML device.
How the ground truth for the training set was established:
- Not Applicable. No training set exists.

Summary of what is described (substitute for the requested table):

This 510(k) summary establishes the device's substantial equivalence through comparison to legally marketed predicate devices, focusing on:

Criteria Category	Description / Performance
Intended Use	Acceptance Criteria: Same as legally marketed predicate devices (Hemi-Hip Replacement).Reported Performance: "The Osteonics, +10 UniPolar Adaptor Sleeve, like the predicate devices cited above, is intended for use with appropriately selected, legally marketed components for Hemi-Hip replacement."
Materials	Acceptance Criteria: Manufactured from materials with a long history of safe orthopedic use, identical to predicate devices.Reported Performance: "Manufactured from the same material - cobalt chromium alloy. The materials used... are not new and have been used for orthopedic applications... for many years."
Design Features	Acceptance Criteria: Consistent with predicate devices, with differences not raising new safety/effectiveness questions.Reported Performance: "A basic taper design," "a smooth exterior finish." Differences in size (one size vs. multiple for predicates) and specific dimensional specifications are acknowledged but deemed not to "raise any new questions of safety or effectiveness."
Mechanical Testing	Acceptance Criteria: (Implicit) Device meets performance standards comparable to predicate devices for mechanical integrity.Reported Performance: "the supporting testing summary, the pre-clinical data incorporated by reference to prior submissions..." (Specific test results are not detailed in this summary document but were part of the full submission).
Sterilization/Packaging	Acceptance Criteria: Standard, accepted methods.Reported Performance: Device "employs standard sterilization and packaging methods."

Conclusion:

This 510(k) submission successfully argues for substantial equivalence to existing devices on the market, implying that because the predicate devices are considered safe and effective, and the new device shares fundamental characteristics, it is also safe and effective. It explicitly states that "None of these design differences raises any new questions of safety or effectiveness." The "study" proving this device meets (implicit) acceptance criteria is the overall 510(k) submission itself, which relies on comparative analysis and references to pre-clinical data.

Summary

{0}------------------------------------------------

2/24/99

Osteonics® +10 Unipolar Adaptor Sleeve

K984585

510(k) Summary

510(k) Premarket Notification Summary of Safety and Effectiveness

Osteonics® +10 UniPolar Adaptor Sleeve

Submission Information

Name and Address of the Sponsor of the 510(k) Submission: 59 Route 17

Contact Person:

Date of Summary Preparation:

Device Identification

Proprietary Name:

Common Name:

Classification Name and Reference:

Howmedica Osteonics Corp. Allendale, NJ 07401-1677

Marybeth Naughton Regulatory Affairs Team Member

December 23, 1998

Osteonics +10 UniPolar Adaptor Sleeve

Prosthesis Hip, Hemi-, Femoral, Metal/Polymer Cemented or Uncemented 21 CFR §888.3390

Predicate Device Identification

The Osteonics +10 UniPolar Adaptor Sleeve is substantially equivalent to the following competitive and/or Osteonics' devices, which have previously been determined substantially equivalent by FDA:

Howmedica Unitrax Unipolar Neck Adjustment Sleeve Component
Osteonics® Neck Extension for Modular Endo head

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

Device Description

The Osteonics +10 UniPolar Adaptor Sleeve is characterized by the following features:

· A basic taper design.
· A smooth exterior finish.
· Constructed of material that has a long history of orthopedic use.

Intended Use:

Indications :

For use as a Hemi-Hip Replacement:

The indications for the use of Osteonics +10 UniPolar Adaptor Sleeve, in keeping with those of other legally marketed Osteonics Hemi-Hip Replacement components, are as follows:

For Use as a 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:

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

{2}------------------------------------------------

Statement of Technological Comparison:

The substantial equivalence of the Osteonics +10 UniPolar Adaptor Sleeve to the predicate devices identified above-in terms of intended use, materials, and design features-is based on the following.

Intended Uses:

The Osteonics, +10 UniPolar Adaptor Sleeve, like the predicate devices cited above, is intended for use with appropriately selected, legally marketed components for Hemi-Hip replacement.

Materials:

The Osteonics +10 UniPolar Adaptor Sleeve and the predicate devices cited above are manufactured from the same material - cobalt chromium alloy. The materials used in the subject device and the predicate devices are not new and have been used for orthopedic applications including hemi-hip replacement in the United States and Europe for many years.

Design:

The design of the Osteonics +10 UniPolar Adaptor Sleeve is consistent with that of the predicate devices and differs in the following:

The Howmedica Unitrax Unipolar Neck Adjustment Sleeve Components are ー available in four sizes while the subject device is available in only one size.
-The Howmedica Unitrax Unipolar Neck Adjustment Sleeve Components differs in dimensional specifications from the subject device. This is consistent with the use of the predicate and subject device in that each is specifically designed with dimensions to accommodate each company's accessory components.
ー The Osteonics" Neck Extension for Modular Endo Head is available in three sizes while the subject device is available in only one size.
-The Osteonics Neck Extension for Modular Endo Head differs in dimensional specifications from the subject device. This is consistent with the use of the predicate and subject device in that each is specifically designed with dimensions to accommodate appropriate Osteonics legally marketed accessory components.

None of these design differences raises any new questions of safety or effectiveness.

Summarv

Based on the similarities and differences presented above, the supporting testing summary, the pre-clinical data incorporated by reference to prior submissions, and the fact that the Osteonics +10 UniPolar Adaptor Sleeve employs standard sterilization and packaging methods, the substantial equivalence of the Osteonics +10 UniPolar Adaptor Sleeve to other legally marketed, class II, components is demonstrated.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 1999

Ms. Elizabeth A. Staub Vice President, Quality Assurance/Regulatory Compliance/Clinical Research Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey

Re: K984585 Osteonics® +10 UniPolar Adaptor Sleeve Trade Name: Requlatory Class: II Product Codes: KWL and KWY December 23, 1998 Dated: December 24, 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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 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.

{4}------------------------------------------------

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

Enclosure

{5}------------------------------------------------

510(k) Number (if known): K 984585

Device Name: Osteonics +10 UniPolar Adaptor Sleeve

Indications For Use:

The indications for use of the Osteonics +10 UniPolar Adaptor Sleeve, in keeping with those of the legally marketed predicate devices, are as follows:

For Use as a 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:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

Over-The-Counter Use

(Per 21 CFR 801.109)

tecotel
(Optional Format 1-2-96)
Division Sign-Off

Division of General Resporative Devices 510(k) Number

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.