METAL TRANSCEND ARTICULATION SYSTEM

K004043 · Wrightmedicaltechnologyinc · JDL · Jul 13, 2001 · Orthopedic

Device Facts

• Record ID: K004043
• Device Name: METAL TRANSCEND ARTICULATION SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: JDL · Orthopedic
• Decision Date: Jul 13, 2001
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3320
• 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 is a total hip arthroplasty prosthesis; consists of metal acetabular shells, metal acetabular liners, and metal femoral heads. Used by orthopedic surgeons in clinical settings to replace hip joint components. Device components are implanted to reduce pain and improve hip function. Acetabular shells feature porous titanium coating for bone integration; internal taper accepts liners. Femoral heads available in multiple sizes and neck lengths. System provides mechanical articulation for hip joint. Clinical benefits include pain relief, improved physical function, and correction of deformities.

Clinical Evidence

Prospective multi-site IDE study. 2-year cumulative survival was clinically equivalent to the Dobbs metal-on-metal cohort (excluding one site with surgical technique issues). Nearly 90% of patients achieved 'at least good' Harris Hip Scores at 1 and 2 years. SF-12 physical function scores increased >50%. Complications and adverse events were rare; radiolucencies >2mm were rare; no subsidence or migration >2mm observed.

Technological Characteristics

Acetabular shell: Ti6Al4V (ASTM F-136/F-620) with porous titanium (ASTM F-67/F-1580) sintered beads. Acetabular liner and femoral head: Cast CoCrMo (ASTM F75). Shell features 18.875° taper, 12 sizes (46-68mm). Liners/heads available in 28, 32, 36mm diameters. Femoral head neck lengths: short, medium, long, extra-long. Single-use, non-active, mechanical implant.

Indications for Use

Indicated for skeletally mature patients requiring 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 a cemented 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. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Reference Devices

• Dobbs metal on metal cohort

Submission Summary (Full Text)

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4o43

Image /page/0/Picture/1 description: The image shows the Wright Medical Technology, Inc. logo and contact information. The logo includes a stylized "W" and the company name in bold letters. Below the company name is the address: 5677 Airline Road, Arlington, TN 38002, and the phone number 901-867-9971. The date "JUL 1 3 2001" is also present on the left side of the image.

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe In accordance with the Pood and Drug Namance with 21 CRF 807, this information serves as a
Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information Medical Devices Act of 1970 and in confession the Metal TRANSCEND® Articulation System.

Submitted By:

Date:

Contact Person:

Proprietary Name:

Common Name:

Classification Name and Reference:

Wright Medical Technology, Inc.

December 28, 2000

Ehab M. Esmail Senior Regulatory Affairs Associate

## Metal TRANSCEND®

### Articulation System

TOTAL HIP SYSTEM

21 CFR 888.3320 Hip joint metal/ metal semiconstrained, with a cemented acetabular component prosthesis - Class III

21 CFR 888.3330 Hip joint metal/ metal semiconstrained, with an uncemented acetabular component prosthesis - Class III

Device Product Code and Panel Code:

Orthopedics/87/KWA, JDL

### 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/25 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 "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller font size.

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- 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 DESCRIPTION B.

The Metal TRANSCEND® Articulation System consists of components that are identical to the previously submitted components under the Metal TRANSCEND® Articulation System IDE: metal acetabular shells, metal acetabular liners, and metal femoral heads.

Design features of the Metal TRANSCEND® Acetabular Shell are summarized below:

- Manufactured from Ti6Al4V conforming to ASTM F-136 or ASTM F620 .
- Porous coated with commercially pure titanium (ASTM F67 or F 1580) sintered . beads
- Features three screw holes and an apical hole ●
- Designed for use with Apical Hole Plug and bone screws .
- Internal geometry of the shell features an 18.8750° (included) taper to accept . acetabular liners
- Available in 12 sizes ranging from 46mm to 68mm in 2mm increments .

Design features of the Metal TRANSCEND® Acetabular Liner are summarized below:

- Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM . E75
- Designed for use with metal acetabular shell .
- Available in three inside diameters: 28mm, 32mm, and 36mm ●

Design features of the Metal TRANSCEND® Femoral Head are summarized below:

- Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM . E75
- Available in three sizes: 28mm, 32mm, and 36mm .
- Available in four neck lengths: short, medium, long, and extra-long ●

#### MATERIALS C.

The materials used for the Metal TRANSCEND® Articulation System are substantially equivalent to competitive devices previously cleared for market and identical to the previously submitted components under the Metal TRANSCEND® Articulation System IDE.

Acetabular Shells

- Titanium Alloy, Ti6Al4V, wrought or forged (ASTM F-136, ASTM F-620) .
Image /page/1/Picture/25 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 "WRIGHT" are the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font, with a thin line underlining the text.

Image /page/1/Picture/26 description: The image shows a black and white drawing of a globe. The globe is tilted and shows the continents of Asia and Australia. The globe is surrounded by a circular frame.

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- Porous coated over the entire exterior surface (ASTM F-67 or F 1580) .
Acetabular Liners

- Cast Cobalt-Chromium-Molybdenum CoCrMo (ASTM F75) .
Femoral Head

- Cast Cobalt-Chromium-Molybdenum CoCrMo (ASTM F75) .
#### D. CLINICAL DATA

The Metal TRANSCEND® Articulation System was previously submitted under the Metal TRANSCEND® Articulation System IDE. Under the IDE, clinical 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-year 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 is as safe and effective as approved predicate devices with clinically equivalent patient outcomes relative to such devices, thus supporting a 510(k) claim.

#### SUBSTANTIAL EQUIVALENCE INFORMATION E.

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/2/Picture/12 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" above the company name. The "W" is composed of three thick, overlapping lines, creating a modern and geometric design. The text "WRIGHT MEDICAL TECHNOLOGY, INC." is printed in a bold, sans-serif font below the "W" symbol.

Image /page/2/Picture/13 description: The image shows a globe. The globe is showing the continents of Asia and Australia. The globe is sitting on a stand.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

JUL 1 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K004043

Trade Name: Metal TRANSCEND Articulation System Regulation Number: 21 CFR 888.3320, 21 CFR 888.3330 Regulatory Class: III Product Code: JDL, KWA Dated: April 16, 2001 Received: April 17, 2001

Dear Mr. Esmail:

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 Continues 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 (Premarket Approval), 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 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 action. In addition, FDA may publish further announcements 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 regulations.

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Page 2 - Mr. Ehab M. Esmail

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 [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" (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 [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark M. Melberson

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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Image /page/5/Picture/0 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 bold, sans-serif font. Below the name is the company's address: 5677 Airline Road, Arlington, TN 38002, and their 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.

Mark N. Melkerson

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

510(k) Number ***_***K004043

Image /page/5/Picture/11 description: The image shows the logo for Wright Medical Technology, Inc. The logo features the word "WRIGHT" in a bold, sans-serif font, with a stylized "W" symbol above it. Below the word "WRIGHT" is the phrase "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font. The overall design is clean and professional.

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Image /page/5/Picture/13 description: The image shows a black and white drawing of a globe. The globe is tilted on its axis and is sitting on a stand. The continents are visible on the globe, and there is a curved line above the globe. The drawing is simple and has a vintage look.