Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity; and,
revision procedures where other treatments or devices have failed.

The Metal TRANSCEND® Articulation System components are for single use only.

Device Description

The previously submitted and cleared Metal TRANSCEND® Articulation System (Exhibit 1: 510(k) K004043) is composed of two pieces, a metal shell and a metal liner that mates to the shell by the use of a taper locking mechanism. This two piece design limits the size of the femoral heads. The use of a monoblock superfinished shell allows larger head sizes to be used. The new Metal TRANSCEND® Articulation System (larger sizes) should increase the range of motion and decrease the risk of dislocation as compared to the current TRANSCEND® (510(k) K004043) Metal on Metal bearing couple.

The Metal TRANSCEND® Articulation System (larger sizes) consists of the following components that are substantially equivalent to the previously cleared components submitted under the Metal TRANSCEND® Articulation System (510(k): K004043): metal monoblock acetabular shells, and metal femoral heads.

Design features of the Metal TRANSCEND® Articulation Monoblock Shell (larger sizes) are summarized below:

Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM . F75
Porous coated with CoCrMo (ASTM F75) Sintered beads ●
Available sizes: ranging from 46mm to 64mm (outer diameter) in 2mm ● increments (The inner diameter of each shell is 10mm smaller than the outer diameter)
. The articulating surface of the implants will be superfinished (1 microinch Ra maximum) to insure form tolerance and a fine surface finish
. A one-piece acetabular shell allows the surgeon to reconstruct the acetabulum while removing very little bone to accommodate a larger Femoral Head.

Design features of the Metal TRANSCEND® Femoral Head (larger sizes) are summarized below:

Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75
Available sizes: 38mm, 40mm, 42mm, 46mm, 48mm, 50mm, 50mm, 52mm, . 54mm
. Available neck lengths: -3.5, 0, +3.5
The articulating surface of the implants will be superfinished (1 microinch Ra ● maximum) to insure form tolerance and a fine surface finish
The taper connection for the Metal TRANSCEND® Femoral Heads (larger sizes) will be identical to the Metal TRANSCEND® Femoral Heads (510(k):K004043) and is intended to be used with our existing femoral stems manufactured with WMT12/14 taper.

AI/ML Overview

1. A table of acceptance criteria and the reported device performance:

The submission does not explicitly define "acceptance criteria" in a quantitative sense with specific performance metrics and thresholds. Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device (Metal TRANSCEND® Articulation System, 510(k): K004043). The key aspect of acceptance is the expectation of similar clinical success based on the equivalence of materials, design features, intended use, and reported wear rates.

However, the clinical data section reports on two key outcomes, which can be interpreted as indicators of "acceptable" performance compared to existing standards:

Acceptance Criteria (Inferred)	Reported Device Performance (Metal TRANSCEND® Articulation System)
2-year cumulative survival (clinically equivalent to predicate)	Clinically equivalent to (no worse than) the Dobbs metal on metal cohort (a reference standard).
"at least good results" by Harris Hip Score (favorable comparison with literature-based cohorts)	Nearly 90% of procedures resulted in "at least good results" at 1 and 2 years, comparing favorably with literature-based cohorts of THR.
SF-12 physical function component score increase	More than a 50% increase in the SF-12 physical function component score.
Complications and adverse events (rare)	Rare.
Radiolucencies >2mm (rare)	Rare.
Subsidence of stem or migration of cup >2mm (none)	There were no findings of subsidence of the stem or migration of the cup >2mm.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated as a single "test set" for this submission. The clinical data cited refers to the data collected for the predicate device (K004043). The study mentions that after excluding one site, the data was analyzed. The exact number of patients included in the analysis for the predicate device is not provided in this document.
Data Provenance: The data was collected prospectively from multi-sites. The document does not specify the country of origin but implies it was a controlled multi-site clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The clinical trial data for the predicate device was collected based on patient outcomes and clinical assessments (e.g., Harris Hip Score), rather than specific "ground truth" established by experts in the context of an AI device.

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

This information is not applicable and therefore not provided, as this is not an AI device validation study requiring expert adjudication of outputs. The clinical data for the predicate device would have involved standard medical assessments by treating physicians.

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 device is a medical implant (total hip system), not an AI-assisted diagnostic or therapeutic device that would involve human "readers" or an AI component in that context.

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

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

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

For the clinical study used to support the predicate device, the "ground truth" was based on patient outcomes data, including:

2-year cumulative survival
Harris Hip Score results (indicating "good results")
SF-12 physical function component score increases
Occurrence of complications and adverse events
Radiolucency measurements
Subsidence or migration of components

8. The sample size for the training set:

Not applicable. This is not an AI device that requires a training set. The clinical data refers to the performance of the predicate device in a clinical trial.

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

Not applicable. As noted above, this is an implant, not an AI device with a training set.

Summary

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JUL 1 2002

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the Metal TRANSCEND® Articulation System.

Submitted By:	Wright Medical Technology, Inc.
Date:	April 26, 2002
Contact Person:	Ehab M. EsmailManager Regulatory Affairs
Proprietary Name:	Metal TRANSCEND®Articulation System (LARGER SIZES)
Common Name:	TOTAL HIP SYSTEM
Classification Name and Reference:	21 CFR 888.3320 Hip joint metal/ metal semi-constrained, with a cemented acetabular componentprosthesis - Class III21 CFR 888.3330 Hip joint metal/ metal semi-constrained, with an uncemented acetabularcomponent prosthesis - Class III
Device Product Code and Panel Code:	Orthopedics/87/KWA

DEVICE INFORMATION

INTENDED USES/ INDICATIONS A.

The Metal TRANSCEND® Articulation System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
1. inflammatory degenerative joint disease such as rheumatoid arthritis;

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1. correction of functional deformity; and,
1. revision procedures where other treatments or devices have failed

The Metal TRANSCEND® Articulation System components are for single use only.

B. DEVICE DESCRIPTION

Design features of the Metal TRANSCEND® Articulation Monoblock Shell (larger sizes) are summarized below:

Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM . F75
Porous coated with CoCrMo (ASTM F75) Sintered beads ●
Available sizes: ranging from 46mm to 64mm (outer diameter) in 2mm ● increments (The inner diameter of each shell is 10mm smaller than the outer diameter)
. The articulating surface of the implants will be superfinished (1 microinch Ra maximum) to insure form tolerance and a fine surface finish
. A one-piece acetabular shell allows the surgeon to reconstruct the acetabulum while removing very little bone to accommodate a larger Femoral Head.

Design features of the Metal TRANSCEND® Femoral Head (larger sizes) are summarized below:

Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75
Available sizes: 38mm, 40mm, 42mm, 46mm, 48mm, 50mm, 50mm, 52mm, . 54mm
. Available neck lengths: -3.5, 0, +3.5
The articulating surface of the implants will be superfinished (1 microinch Ra ● maximum) to insure form tolerance and a fine surface finish
The taper connection for the Metal TRANSCEND® Femoral Heads (larger sizes) will be identical to the Metal TRANSCEND® Femoral Heads (510(k):K004043) and is intended to be used with our existing femoral stems manufactured with WMT12/14 taper.

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C. MATERIALS

The materials used for the Metal TRANSCEND® Articulation System (larger sizes) are substantially equivalent to competitive devices previously cleared for market.

Monoblock Acetabular Shells

Cast Cobalt-Chromium-Molybdenum CoCrMo (ASTM F75)
Porous coated with CoCrMo (ASTM F75) Sintered beads .

Femoral Head

Cast Cobalt-Chromium-Molybdenum CoCrMo (ASTM F75) ●

D. CLINICAL DATA

The intended use, material, design features, type of interface, and reported ware rates of the Metal TRANSCEND® Articulation System (larger heads) are substantially equivalent to the previously submitted and cleared Metal TRANSCEND® Articulation System (510(k): K004043).

Therefore, Clinical success similar to that of the previously cleared components submitted under the Metal TRANSCEND® Articulation System (510(k) K004043) is expected. The clinical data (TRANSCEND® Metal Articulation System Controlled Clinical Trial in support of 510(k) Statistical Analysis Report Version 8.0 December 23, 2000- Volume 1 & 2) was previously submitted under the Metal TRANSCEND® Articulation System (510(k) K004043). The data was collected prospectively from multi-sites. After excluding a single site with significantly poorer survival than all other sites that was identified as having problems with surgical technique. 2-vear cumulative survival was found to be clinically equivalent to (no worse than) the Dobbs metal on metal cohort. Nearly 90% of procedures resulted in "at least good results" at 1 and 2 years as determined by the Harris Hip Score, results that compared favorably with literature-based cohorts of THR. There was more than a 50% increase in the SF-12 physical function component score. Complications and adverse events were rare. Radiolucencies >2mm were rare. There were no findings of subsidence of the stem or migration of the cup >2mm.

In conclusion, this controlled clinical trial provides substantial evidence that the Metal TRANSCEND™ Articulation System (larger sizes) is as safe and effective as approved predicate devices with clinically equivalent patient outcomes relative to such devices, thus supporting a 510(k) claim.

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E. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material, type of interface, and design features of the Metal TRANSCEND® Articulation System are substantially equivalent to the competitive devices. The safety and effectiveness of the Metal TRANSCEND® Articulation System are adequately supported by the substantial equivalence information, materials data, testing results, and clinical data provided within this Premarket Notification.

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510(K) SUMMARY ````

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 2002 JUL

Mr. Ehab M. Esmail Manager Regulatory Affairs Wright Medical Technology 5677 Airline Road Arlington, Tennessee 38002

Re: K021349

Trade Name: Metal TRANSCEND® Articular System (Larger Sizes) Regulation Number: 21 CRF 888.3320 and 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and Hip ioint metal/ metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA Dated: April 26, 2002

Received: April 29, 2002

Dear Mr. Esmail:

We have reviewed your Section 510(k) premarket 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) 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 (QS) 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. Ehab M. Esmail

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

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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Metal TRANSCEND® Articulation System

INDICATIONS STATEMENT

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
1. inflammatory degenerative joint disease such as rheumatoid arthritis;
1. correction of functional deformity; and,
1. revision procedures where other treatments or devices have failed.

Styph Rurdia

(Division Sign-Off) Division of General, Restorative and Neurological Devices

K021349 510(k) Number __

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INDICATIONS STATEMENT

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.