MAESTRO TOTAL WRIST

K042032 · Biomet, Inc. · JWJ · Oct 7, 2004 · Orthopedic

Device Facts

• Record ID: K042032
• Device Name: MAESTRO TOTAL WRIST
• Applicant: Biomet, Inc.
• Product Code: JWJ · Orthopedic
• Decision Date: Oct 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Maestro™ Total Wrist System is indicated for use as a replacement of wrist joints disabled by pain, deformity and/or limited motion caused by: 1) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis 2) Rheumatoid arthritis 3) Revision where other devices or treatments have failed 4) Scapholunate Advanced Collapse (SLAC) and other functional deformities 5) Trauma, including fractures of the distal radius and/or carpal bones. The device is intended to be implanted with bone cement.

Device Story

Maestro™ Total Wrist System is a semi-constrained, cemented wrist prosthesis; replaces wrist joints disabled by pain, deformity, or limited motion. System comprises a radial component with a molded polyethylene bearing and a modular stem, plus a three-piece carpal component (carpal head, carpal plate, capitate stem). Carpal head available in three heights (+2, +4) to address soft tissue laxity; modular stems allow surgeon adjustment. Implanted in the operating room by a surgeon using bone cement. Device restores joint function and relieves pain for patients with degenerative, rheumatoid, or traumatic wrist conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing.

Technological Characteristics

Semi-constrained, cemented wrist prosthesis. Materials include metal and polyethylene. Modular design with radial component (molded polyethylene bearing, modular stem) and three-piece carpal component (carpal head, carpal plate, capitate stem).

Indications for Use

Indicated for patients with wrist joint disability due to pain, deformity, or limited motion resulting from non-inflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), rheumatoid arthritis, failed prior treatments/revisions, SLAC, or trauma (distal radius/carpal fractures).

Regulatory Classification

Identification

A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist 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 have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) 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).

Predicate Devices

• Ten (DePuy Orthopedics, Inc.) (K031203)
• Blax™ A.F. Wrist System (Biomet Orthopedics) (K020554 & K030037)

Submission Summary (Full Text)

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OCT 7 - 2004

K642032

BIOMET

## 510(k) Summary

Applicant/Sponsor: Biomet Manufacturing Corp.

Patricia Sandborn Beres Contact Person: Senior Regulatory Specialist

Proprietary Name: Maestro™ Total Wrist

Total Wrist Joint Common Name:

Classification Name: Wrist joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3800)

Legally Marketed Devices To Which Substantial Equivalence !s Claimed:

y Marketed Devroos Ten (DePuy Orthopedics, Inc.) – K031203 Blax™ A.F. Wilst System (Bor ay Orthopsers) - K020554 & K030037

Device Description: The Maestro™ Total Wrist System consists of a two piece Device Description: The Macotro and a three-piece carpal component.
radial component with a molded bearing and a three-piece carparent. The radial component with a moided body with a modular stem. The The fadial component is composse of a ather sheet polyethylene bearing
distal bodies come in three sizes and have a molded polyethylone bearing distal bodies come in thice sized and have the operating room by a screw surface. The stem is modular, assemblou in the operation of the managements – a carpal head, assembly. The carpal component ochoice or to ead comes in 3 heights, standard,
a carpal plate and a capitate stem. The carpal head comes in 3 heights of a carpar plate and a capitale stom. This othpan road tissue laxity. Two lengths of
+2 and +4. This allows the surgeon to adjust for soft tissue laxiby the radiol stoma +2 and +4. This allows the surgeon to aujust for aujust for surement. Like the radial stems,
carpal plates give the surgeon options of screw plates and bood carpar plates grro the carge the capitate stems to the plate and head.

Intended Use: The Maestro™ Total Wrist System is indicated for use as a Intended USe. The MacStro - Tecal vince of the Cycle relieve and/or limited motion caused by:

- caused by.
1) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis
- 2) Rheumatoid arthritis
- 2 / Rhoumatold artillions or treatments have failed
- 5) Revision where other devices of treather functional deformities
4) Scapholunate Advanced Collapse (SLAC) and other functional deformities
- 4) Scapholunate Autorial ss of the distal radius and/or carpal bones

The device is intended to be implanted with bone cement.

| MAILING ADDRESS | P.O. Box 587 |
|------------------|------------------|
| SHIPPING ADDRESS | 56 E. Bell Drive |
| | Warsaw, IN 46581 |

| OFFICE | 574.267.6639 |
|--------|-------------------|
| FAX | 574.267.8137 |
| E-MAIL | [e-mail] |

151

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510(k) Summary Maestro™ Total Wrist Page 2

Summary of Technologies: The overall design, materials, surface finishes and
esses of Technologic The Wijat or similar or identical to the predicate Summary of Technologies. The overall design, materials,
processing of the Maestro™ Total Wrist are similar or identical to the predicate devices.

Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to the noff-om under expected clinical conditions.

Clinical Testing: None provided

All trademarks are owned by Biomet, Inc .except for the following:
All trademarks are owners . Be . Online . Incorporated All trademarks are owned by orthopaedics, Incorporated Blax is a trademarks of Bor ay enimes Medical Incorporated.

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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 & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is black and white.

OCT 7 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corporation 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K042032

K042052
Trade/Device Name: Maestro™ Total Wrist System Regulation Number: 21 CFR 888.3800 Regulation Name: Wrist joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWJ Dated: July 27, 2004 Received: July 28, 2004

Dear Ms. Beres:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your becaon 310(t) presidentially equivalent (for the indications felerenced above and nave determined in a weet ed predicate devices marketed in interstate for use stated in the cherosure) to regally attend date of the Medical Device American be to commence provided in accordance with the provisions of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tournal, controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is blushined (soo a croyals. Existing major regulations affecting your device can may be subject to sater additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Teast be advised that I Dris assuates over device complies with other requirements of the Act that I DA has made a dolorimistered by other Federal agencies. You must of any I ederal studies and registanents, including, but not limited to: registration and listing (21 comply will an the Fee orequirements)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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## Page 2 - Patricia Sandborn Beres

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.

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

Sincerely vours,

Sincerely yours,
Mark A. Millman

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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## Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Maestro™ Total Wrist System

Indications For Use: The Maestro™ Total Wrist System is indicated for use as a Indications For Use: The Maestly -- Total White Oyoline innited motion caused by:
replacement of wrist joints disabled by pain, deformity and/or limited motio placement of wrist Joints uisabled by pain, dolorhilly and the sumatic

K042032

- arthritis and avascular necrosis
- 2) Rheumatoid arthritis
- 2) Theumatold antinatore articles or treatments have failed
- 3) Revision where other devices of transmission in the functional deformities
4) Scapholunate Advanced Collapse (SLAC) and other carpal bones
- 4) Scapholunate Auvanced Collapse (SEAS)
5) Trauma, including fractures of the distal radius and/or carpal bones

The device is intended to be implanted with bone cement.

× Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device/Evaluation (ODE)

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

**510(k) Number** K042032 Page 1 of