MAESTRO WRIST FRACTURE IMPLANT

K080426 · Biomet Manufacturing Corp · JWJ · Jul 29, 2008 · Orthopedic

Device Facts

• Record ID: K080426
• Device Name: MAESTRO WRIST FRACTURE IMPLANT
• Applicant: Biomet Manufacturing Corp
• Product Code: JWJ · Orthopedic
• Decision Date: Jul 29, 2008
• 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: - Non-inflammatory degenerative joint disease including osteoarthritis, traumatic 1) arthritis and avascular necrosis. - 2) Rheumatoid arthritis. - Revision where other devices or treatments have failed. 3) - Scapholunate Advanced Collapse (SLAC) and other functional deformities. 4) - Trauma, including fractures of the distal radius and/or carpal bones. 5) The radial and carpal components are intended to be implanted with bone cement.

Device Story

Maestro™ Wrist Fracture Implant is a semi-constrained, cemented total wrist replacement system. Device consists of a two-piece radial component (distal body with modular stem) and a tapered carpal component (polyethylene carpal head on metallic base, carpal plate, and capitate stem). Carpal plate features threaded screw holes for spherical locking screws (fixed or variable angle). Implanted by orthopedic surgeons in a clinical/OR setting to replace diseased or traumatized wrist joints. System restores joint function by replacing damaged bone/cartilage with metal/polymer components fixed with bone cement. Output is a reconstructed wrist joint providing stability and motion.

Clinical Evidence

No clinical data provided. Substantial equivalence based on non-clinical laboratory testing demonstrating device functionality within its intended use.

Technological Characteristics

Semi-constrained, cemented wrist prosthesis. Materials include metal and polymer. Components: radial body with modular stem, carpal head (polyethylene on metallic base), carpal plate, capitate stem, and spherical locking screws. Fixation via bone cement.

Indications for Use

Indicated for patients requiring wrist joint replacement due to pain, deformity, or limited motion from osteoarthritis, traumatic arthritis, avascular necrosis, rheumatoid arthritis, SLAC, functional deformities, or trauma (distal radius/carpal fractures), including revision cases.

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

• Maestro™ Total Wrist System (K042032)
• Maestro™ Carpal HemiArthroplasty (K050028)

Submission Summary (Full Text)

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K080426 pg lot2

Image /page/0/Picture/1 description: The image shows the logo for Biomet Orthopedics, Inc. The logo consists of the word "BIOMET" in a stylized, blocky font, with a registered trademark symbol to the right of the word. Below the word "BIOMET" is the phrase "ORTHOPEDICS, INC." in a smaller, simpler font. The logo is black and white.

# 510(k) Summary

### Preparation Date: July 7, 2008

Applicant/Sponsor:Biomet Manufacturing Corp. 56 East Bell Drive Warsaw, IN 46582

JUL 2 9 2008

Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist

Proprietary Name: Maestro™ Wrist Fracture Implant

Common Name: Total wrist replacement device

#### Classification Name:

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

# Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

- · Maestro™ Total Wrist System, 510(k) K042032
- · Maestro™ Carpal HemiArthroplasty, 510(k) K050028

#### Device Description:

The Maestro™ Wrist Fracture Replacement System consists of a two piece radial component and a molded carpal bearing component for total wrist replacement. The radial component is composed of a distal body with a modular stem. The distal bodies have a highly polished bearing surface located anatomically. The Maestro™ Tapered Carpal Component is composed of three subcomponents - a carpal head, a carpal plate and a capitate stem. The carpal head is composed of polyethylene molded on to a metallic base. The carpal plate has a male taper which mates with a female taper in the carpal head. The plate features threaded screw holes that mate with the heads of spherical locking screws. Screws are available with both fixed and variable heads. The variable screws allow the surgeon to angle the screws upon insertion while still locking the screws to the plate. The capitate stem then screws into internal threads on the reverse side of the taper on the carpal plate to complete the implant.

**Mailing Address:**

P.O. Box 587
Warsaw, IN 46581-0587
Toll Free: 800.348.9500
Office: 574.267.6639
Main Fax: [phone]
www.biomet.com

**Shipping Address:**
56 East Bell Drive
Warsaw, IN 46582

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K080426 pg 2 of 2

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:

- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic 1) arthritis and avascular necrosis.
- 2) Rheumatoid arthritis.
- Revision where other devices or treatments have failed. 3)
- Scapholunate Advanced Collapse (SLAC) and other functional deformities. 4)
- Trauma, including fractures of the distal radius and/or carpal bones. 5)

The radial and carpal components are intended to be implanted with bone cement.

Summary of Technologies: The Maestro™ Wrist Fracture Implant has similar technologies as the predicate device.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc.

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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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corp. % Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 East Bell Drive Warsaw, IN 46582

JUL 2 9 2008

Re: K080426 Trade/Device Name: Maestro Wrist Fracture Implant Regulation Number: 21 CFR 888.3800 Regulation Name: Wrist joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWJ Dated: July 21, 2008 Received: July 22, 2008

Dear Ms. Beres:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 - Ms. Patricia Sandborn Beres

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Millican

Mark N. Melkerson 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): ___K080426

Device Name: Maestro™ Wrist Fracture Implant

Indications For 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:

- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic 1) arthritis and avascular necrosis.
- Rheumatoid arthritis. 2)
- Revision where other devices or treatments have failed. 3)
- Scapholunate Advanced Collapse (SLAC) and other functional deformities. 4)
- Trauma, including fractures of the distal radius and/or carpal bones. 5)

The radial and carpal components are intended to be implanted with bone cement.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (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) |
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Mark A. McHenas(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K080426