The Wagner Cone Prosthesis is intended for prosthetic replacement of the proximal portion of the femur in total hip arthroplasty. This device is intended for cementless application where primary fixation occurs predominantly in the distal region. Specific diagnostic indications for use of the Wagner Cone Prosthesis are:

patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis;
those patients with failed previous surgery where pain, deformity, or dysfunction persists;
revision of previously failed hip arthroplasty.

Device Description

This stem is a titanium-aluminum-niobium alloy conical configuration with a taper. The design features a circular cross-section with eight equally spaced conical longitudinal flutes down the long axis of the stem for rotational stability. The stem's core diameter tapers gradually from the proximal end to the distal end.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Wagner Cone Prosthesis, a hip joint implant. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, device performance metrics, or study results in the context of AI/ML device evaluation.

The 510(k) approval process for orthopedic implants typically relies on demonstrating substantial equivalence to a legally marketed predicate device through:

Design comparisons: Showing the new device has similar materials, design features, and operating principles to approved predicate devices.
Functional analyses: Testing the physical and mechanical properties of the device (e.g., strength, fatigue life, wear resistance) to show it performs comparably to or better than predicate devices. These tests are usually conducted in a laboratory setting according to recognized standards (e.g., ISO, ASTM).
Performance tests: These refer to mechanical and material tests, not clinical performance in the sense of a diagnostic or predictive AI/ML model.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details related to AI/ML device performance from this document. The questions you've asked (sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are highly relevant to AI/ML device submissions but are not addressed in this type of traditional medical device 510(k) summary.

Summary

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510(k) SUMMARY

SPONSOR NAME:	Centerpulse Orthopedics, Inc.9900 Spectrum DriveAustin, TX 78717
510(k) CONTACT:	Robert M. WolfarthPhone: (512) 432-9324E-Mail: Robert.Wolfarth@Centerpulse.com
TRADE NAME:	Wagner Cone Prosthesis
COMMON NAME:	Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis
CLASSIFICATION:	Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prostheses (Product Code 87 LZO) are ClassII per 21 CFR §888.3353, reviewed by the Orthopedic Devices panel.

PREDICATE DEVICES:

MP™ Reconstruction Hip Stem by Waldemar Link GmbH & Co KG. (K955296) ●
Restoration™ Modular System by Howmedica Osteonics Corp. (K022549) ●
Wagner Revision Stem (K960588) .
Precedent Revision Hip Stem (K972637) .

DEVICE DESCRIPTION:

INTENDED USE:

patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis;
those patients with failed previous surgery where pain, deformity, or dysfunction persists;
. revision of previously failed hip arthroplasty.

BASIS OF SUBSTANTIAL EQUIVALENCE:

Performance tests, design comparisons, and functional analyses conducted on the Wagner Cone Prosthesis demonstrate that it is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2003

Mr. Robert M. Wolfarth Regulatory Affairs Programs Manager Centerpulse Orthopedics, Inc. 9900 Spectrum Drive Austin, TX 78717

Re: K032380 Trade/Device Name: Wagner Cone Prosthesis 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: July 30, 2003 Received: August 1, 2003

Dear Mr. Wolfarth:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Robert M. Wolfarth

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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 Manufacturers, International 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,

Mark M Millham

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

Enclosure

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K032380

Indications For Use

510(K) Number.

Wagner Cone Prosthesis Device Name:

Indications for Use:

patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., . avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis;
those patients with failed previous surgery where pain, deformity, or dysfunction . persists;
revision of previously failed hip arthroplasty. ●

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)

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(Division Sign-Off)
D. ision of General, Restorative
and Neurological Devices
510(k) Number. K032380

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.