The Wagner SL Revision Stem Lateral is intended for prosthetic replacement of the proximal femur in total hip arthroplasty. It is intended for press-fit application. Specific diagnostic indications include:

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

Device Description

Both the existing Wagner SL Revision Stem and the proposed Wagner SL Revision Stem Lateral are manufactured from forged titanium alloy and are available in three lengths (165mm, 185mm, and 205mm). The neck design of both stems is provided with the standard 12/14 taper for connection with any Zimmer modular femoral head utilizing a 12/14 taper.

The Wagner SL Revision Stem Lateral incorporates a circular stem cross-section and equally spaced conical anchorage ribs, which run nearly the full length of the stem, as do the ribs on the previously cleared Wagner SL Revision Stem. The surface of both stems is rough-blasted.

To achieve the lateralization of the modified device, the CCD (i.e., neck) angle was lengthened. To compensate for the increased bending moments and lateral stresses, which result from the increased offset, the rib structure was modified so that the greatest bending moment would not be at the base of the rib; and the ribs were widened, which led to an increase in the stem strength.

In addition, a threaded coupling was added to the proximal portion of the stem for use with the new impacter/extractor. The stem neck was shortened to increase the range of motion, and two small holes were added to the proximal portion of the stem for securing non-metallic suture material.

AI/ML Overview

This document is a 510(k) summary for a medical device (hip implant) and does not contain detailed information about acceptance criteria or specific study results that would typically be associated with AI/ML device performance. The document focuses on demonstrating substantial equivalence to a predicate device.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details for an AI/ML device is not applicable to this document. The document describes a traditional medical device (hip implant) submission, not an AI/powered diagnostic or therapeutic device.

However, I can extract information related to the device description, intended use, and the concept of "substantial equivalence" as the primary "acceptance criterion" in this context.

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

In the context of a 510(k) submission for a non-AI/ML medical device, the "acceptance criteria" are generally that the new device is substantially equivalent to a legally marketed predicate device. This substantial equivalence is demonstrated through comparisons of:

Implied Acceptance Criterion (for Substantial Equivalence)	Reported Device Performance (Comparison of Wagner SL Revision Stem Lateral to Predicate: Wagner SL Revision Stem)
Material Composition	Both manufactured from forged titanium alloy.
Available Sizes	Both available in three lengths (155mm, 180mm, 205mm).
Neck Design	Both provided with the standard 12/14 taper for connection with Zimmer modular femoral heads.
Stem Cross-Section	Both incorporate a circular stem cross-section.
Anchorage Ribs	Both have equally spaced conical anchorage ribs running nearly the full length of the stem.
Surface Treatment	Both have a rough-blasted surface.
Intended Use	Both intended for prosthetic replacement of the proximal femur in total hip arthroplasty, for press-fit application, addressing similar diagnostic indications (NIDJD, IJD, failed previous surgery, revision arthroplasty).
Fundamental Design	"The device, as modified, is substantially equivalent in terms of fundamental design..." (Statement in "Basis of Substantial Equivalence")
Indications for Use	"...indications for use and intended use to the previously cleared, currently marketed Wagner SL Revision Stem." (Statement in "Basis of Substantial Equivalence")

Note: The modifications in the "Wagner SL Revision Stem Lateral" (lengthened CCD angle, widened ribs for increased stem strength, threaded coupling, shortened stem neck, added holes for sutures) are presented as design changes that do not alter the fundamental safety and effectiveness to the point of requiring a PMA or new classification, thus maintaining substantial equivalence. These changes are improvements or variations within the established scope of the predicate.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document describes a traditional medical device (hip implant) and does not include information on a "test set" in the context of an AI/ML algorithm evaluation. The demonstration of substantial equivalence relies on design comparisons, material specifications, and performance characteristics (like strength considerations due to design changes). There are no data described that would fit the "test set" definition for an AI/ML device.

3. 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. As noted above, this 510(k) summary does not involve a "test set" or "ground truth" establishment by experts in the AI/ML sense. The approval is based on comparison to a predicate device and engineering design principles.

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

Not applicable. There is no described "test set" or adjudication process for clinical data 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 is a hip implant, not an AI/ML diagnostic device, so MRMC studies are not relevant.

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

Not applicable. This is a hip implant, not an AI/ML algorithm.

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

Not applicable. For a hip implant 510(k), "ground truth" typically relates to established clinical performance of the predicate device, material standards, and biomechanical principles, rather than a diagnostic 'truth' established for an AI algorithm.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm or associated "training set" described in this document.

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

Not applicable. There is no AI/ML algorithm or associated "training set" described in this document.

Summary

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K04 3356 (pg 1 of 2)

APR 1 8 2005

510(k) SUMMARY

Zimmer Austin, Inc. SPONSOR NAME: 9900 Spectrum Drive Austin, TX 78717

Zimmer GmbH MANUFACTURER: Sulzer Allee 8 Winterthur, 8404 Switzerland
Audrey Swearingen CONTACT: Phone: (512) 432-9255 audrey.swearingen@zimmer.com E-Mail:

Wagner SL Revision Stem Lateral TRADE NAME:

Hip joint metal/ceramic/polymer semi-constrained cemented COMMON NAME: or nonporous uncemented prosthesis

Hip joint metal/ceramic/polymer semi-constrained cemented CLASSIFICATION: or nonporous uncemented prostheses (Product Code 87 LZO) are Class II per 21 CFR §888.3353, reviewed by the Orthopedic Devices panel.

PREDICATE DEVICE: Wagner SL Revision Stem (K953689)

DEVICE DESCRIPTION:

Both the existing Wagner SL Revision Stem and the proposed Wagner SL Revision Stem Lateral are manufactured from forged titanium alloy and are available in three ിശേഷം വി 6 managan 6 managan (205mm). The neck design of both stems is provided with the standard 12/14 taper for connection with any Zimmer modular femoral head utilizing a 12/14 taper.

The Wagner SL Revision Stem Lateral incorporates a circular stem cross-section and equally spaced conical anchorage ribs, which run nearly the full length of the stem, as do oducily open a previously cleared Wagner SL Revision Stem. The surface of both stems is rough-blasted.

To achieve the lateralization of the modified device, the CCD (i.e., neck) angle was To acrieve the fateralization of the lengthened. To compensate for the increased bending moments and lateral stresses, which result from the increased offset, the rib bending momonto and later of so that the greatest bending moment would not be structure was rib; and the ribs were widened, which led to an increase in the stem strength.

In addition, a threaded coupling was added to the proximal portion of the stem for use m' addition, a throuded couping was shortened and the stem neck with the new impacterese the range of motion, and two small holes were added to the proximal portion of the stem for securing non-metallic suture material.

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K043356 (pg. 2 of 2)

INTENDED USE:

INTENDED OSE.
The Wagner SL Revision Stem Lateral is intended for prosthetic replacement of the The Wagner OL Tevilion of the Eater Eater hip arthroplasty. It is intended for press-fit application. Specific diagnostic indications include:

ിരക്കം Openino diagnootio immetory degenerative joint disease (NIDJD), e.g., � r attent conditions of neninthritis; and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
medifiation artimas.
Patients with failed previous surgery where pain, deformity, or dysfunction persists. �
Revision of previously failed hip arthroplasty. �

BASIS OF SUBSTANTIAL EQUIVALENCE:

BASIS OF OODOTARTIAly equivalent in terms of fundamental design, The device, as modified, to casations for use and intended use to the previously cleared, currently marketed Wagner SL Revision Stem.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized lines or strokes, possibly representing a stylized human figure or a symbol of health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 8 2005

Ms. Audry Swearingen Regulatory Affairs Manager Zimmer Austin, Inc. 9900 Spectrum Drive Austin, Texas 78717

Re: K043356

Trade/Device Name: Wagner SL Revision Stem Lateral 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: March 17, 2005

Received: March 21, 2005

Dear Ms. Swearingen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 3 rQtr) premised is substantially equivalent (for the indications felerenced above and nave determined in marketed predicate devices marketed in interstate for use stated in the encrosure) to regally to regally the Medical Device Amendments, or to conninetee prior to May 20, 1978, the exactions of the Federal Food, Drug, devices that have been reclassified in accerative while in a premarket approval application (PMA). and Cosment Act (Act) that do not require appen o the general controls provisions of the Act. The You may, merelore, market the act include requirements for annual registration, listing of general controls provisions of the rist labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (36c doove) inc. Existing major regulations affecting your device all in a liting EDA it may be subject to such additional conditions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Code of Feasta, concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not t Please be advised that I DA 3 issuales of a cosenia
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a delemination administered by other Federal agencies. You must or any receral statutes and regulations and admitted to: registration and listing (21 comply with an the Act 3 requirements, mercessed ing practice requirements as set and CFR Part 807), labeling (21 CFRT art 807), good and frapplicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820), and 11 applicable, 1950 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 – Ms. Audry Swearingen

This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin marketing your artial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of the p premarket notification. The PDATIManig of basisting of 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
s and the may and and and and and the color station and the reculation cont if you desire specific advice for your active of your and success not the regulation entitled, the open abtain contact the Office of Collipitalice at (240) 270 Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 ct first from the Division of Small "Misbranding by relerence to premarks noutheanon" (2) 300 the Division of Small other general information on your responsion.com its toll-free number (800) 638-2041 or 100-Manufacturers, International and Consumer Prosisanet Prosisanter Propport/index.html.

Sincerely yours,

Stupt Plurle

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 15043356

Wagner SL Revision Stem Lateral Device Name:

Indications for Use:

The Wagner SL Revision Stem Lateral is intended for prosthetic replacement of the proximal Price wagner BB reviewing total hip arthroplasty. It is intended for press-fit application. Specific diagnostic indications include:

Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular � necrosis, osteoarthritis; and inflammatory joint disease (IJD), e.g., theumatoid arthritis.
Patients with failed previous surgery where pain, deformity, or dysfunction persists. �
Revision of previously failed hip arthroplasty. �

Prescription Use
X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stupt Rlurdu

(Division Sign-Division of General, From Stive. and Neurological Devices

510(k) Number K043356

Page of __ of_

(Posted November 13, 2003)

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.