METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)

K021349 · Wrightmedicaltechnologyinc · KWA · Jul 1, 2002 · Orthopedic

Device Facts

• Record ID: K021349
• Device Name: METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KWA · Orthopedic
• Decision Date: Jul 1, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

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; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The Metal TRANSCEND® Articulation System components are for single use only.

Device Story

Metal TRANSCEND® Articulation System (larger sizes) is a total hip arthroplasty implant system. It consists of a monoblock acetabular shell and femoral head, both manufactured from cast cobalt-chromium-molybdenum (CoCrMo). The system is designed to replace the hip joint in patients requiring arthroplasty. The monoblock shell design allows for larger femoral head sizes compared to the previous two-piece design (K004043), aiming to increase range of motion and decrease dislocation risk. The device is implanted by an orthopedic surgeon in a clinical/hospital setting. The articulating surfaces are superfinished to ensure form tolerance and fine surface finish. The femoral heads are compatible with existing femoral stems using a WMT12/14 taper. The device provides a metal-on-metal bearing couple for the hip joint, intended to restore function and reduce pain.

Clinical Evidence

Clinical evidence relies on prospective multi-site data previously submitted for the predicate (K004043). Analysis of 2-year cumulative survival showed clinical equivalence to the Dobbs metal-on-metal cohort. Nearly 90% of procedures achieved 'at least good' results at 1 and 2 years per Harris Hip Score. SF-12 physical function scores increased by >50%. Complications, adverse events, and radiolucencies >2mm were rare; no stem subsidence or cup migration >2mm observed.

Technological Characteristics

Components: Monoblock acetabular shells (46-64mm OD) and femoral heads (38-54mm). Material: Cast cobalt-chromium-molybdenum (ASTM F75). Shells feature porous coating with sintered CoCrMo beads. Articulating surfaces are superfinished (1 microinch Ra max). Connection: Taper locking mechanism (WMT12/14 taper). Single-use, non-sterile/sterile (implied by orthopedic standard).

Indications for Use

Indicated for skeletally mature patients undergoing total hip arthroplasty for pain relief or improved function due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity, or revision of failed prior treatments.

Regulatory Classification

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).

Predicate Devices

• Metal TRANSCEND® Articulation System (K004043)

Reference Devices

• Dobbs metal on metal cohort

Submission Summary (Full Text)

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

JUL 1 2002

Image /page/0/Picture/2 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol on the left, followed by the company name in bold, uppercase letters. Below the company name, the address "5677 Airline Road, Arlington, TN 38002" and phone number "901-867-9971" are printed in a smaller font.

# 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. Esmail<br>Manager Regulatory Affairs |
| Proprietary Name: | Metal TRANSCEND®<br>Articulation System (LARGER SIZES) |
| Common Name: | TOTAL HIP SYSTEM |
| Classification Name and Reference: | 21 CFR 888.3320 Hip joint metal/ metal semi-<br>constrained, with a cemented acetabular component<br>prosthesis - Class III<br>21 CFR 888.3330 Hip joint metal/ metal semi-<br>constrained, with an uncemented acetabular<br>component 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;
- 2. inflammatory degenerative joint disease such as rheumatoid arthritis;

Image /page/0/Picture/12 description: The image shows a black and white drawing of a globe. The globe is partially surrounded by a ring, possibly representing an orbit or atmosphere. The continents are visible on the globe, but the details are not very clear due to the image quality.

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

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

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

#### B. 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.

Image /page/1/Picture/19 description: The image shows a black and white drawing of a planet. The planet has a rough, textured surface with dark and light areas. There is a ring around the planet, and a dark spot at the bottom.

Image /page/1/Picture/21 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, sans-serif font. Below the word "WRIGHT" are the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font with a line above the words.

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

#### 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.

Image /page/2/Picture/12 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a serif font. Below the word "WRIGHT" are the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font.

Image /page/2/Picture/13 description: The image shows a black and white drawing of a globe. The globe is partially visible, with the top portion of the globe being cut off. The continents are visible on the globe, and the oceans are represented by a lighter shade of gray. The globe is sitting on a stand, which is also visible in the image.

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

#### 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.

Image /page/3/Picture/3 description: The image shows a black and white drawing of a globe. The globe is partially shaded, with the shading concentrated on the left side. A curved line is visible above the globe, suggesting an atmospheric layer or a halo effect. The bottom of the globe is less defined, fading into the background.

510(K) SUMMARY ````

Image /page/3/Picture/5 description: The image shows the logo for Wright Medical Technology, Inc. The logo consists of a stylized "W" symbol above the word "WRIGHT" in a bold, sans-serif font. Below the word "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font. The overall design is simple and professional.

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the left side. To the right of the text is a symbol consisting of three stylized human profiles facing right, stacked vertically. The acronym "USA" is located above the profiles.

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.

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

### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image contains a sequence of alphanumeric characters, specifically "K021544". The characters are written in a handwritten style, with varying stroke thicknesses. The characters are all uppercase, and the numbers are written in a simple, clear style.

Image /page/6/Picture/1 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" on the left, followed by the company name in a clear, sans-serif font. Below the company name is the address: 5677 Airline Road, Arlington, TN 38002, and the phone number 901-867-9971.

# 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;
- 2) inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3) correction of functional deformity; and,
- 4) 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 __

Image /page/6/Picture/12 description: The image shows a black and white drawing of a cell. The cell appears to be eukaryotic, as it contains a nucleus. The cell membrane is visible, as well as other organelles within the cytoplasm.

Image /page/6/Picture/13 description: The image shows the logo for Wright Medical Technology, Inc. The logo features the word "WRIGHT" in large, bold, sans-serif font. Above the word "WRIGHT" is a stylized "W" symbol. Below the word "WRIGHT" is the phrase "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font, underlined by a thin line.

INDICATIONS STATEMENT