MAESTRO CARPAL HEMIARTHROPLASTY

K050028 · Biomet Manufacturing, Inc. · KWN · Mar 25, 2005 · Orthopedic

Device Facts

• Record ID: K050028
• Device Name: MAESTRO CARPAL HEMIARTHROPLASTY
• Applicant: Biomet Manufacturing, Inc.
• Product Code: KWN · Orthopedic
• Decision Date: Mar 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Maestro™ Carpal HemiArthroplasty 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 carpal bones The device is intended to be implanted with bone cement.

Device Story

Maestro™ Carpal HemiArthroplasty is a three-piece orthopedic implant designed to replace the lunate and scaphoid bones; articulates with natural radial bone. Components include carpal head (three heights for soft tissue laxity adjustment), carpal plate (two lengths for screw placement), and capitate stem. Implanted by orthopedic surgeons in clinical settings using bone cement. Device restores joint function, reduces pain, and corrects deformity in patients with degenerative or traumatic wrist conditions.

Clinical Evidence

No clinical data provided. Mechanical bench testing performed to demonstrate device ability to perform under expected clinical conditions.

Technological Characteristics

Three-piece carpal hemiarthroplasty system. Components: carpal head, carpal plate, capitate stem. Materials, surface finishes, and processing are similar to predicate titanium implants. Designed for fixation with bone cement. No software or electronic components.

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, SLAC, or carpal bone trauma.

Regulatory Classification

Identification

A wrist joint carpal lunate prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal lunate bone of the wrist.

Predicate Devices

• Swanson Titanium Carpal Scaphoid Implant (K864490)
• Swanson Titanium Carpal Lunate Implant (K864491)
• Maestro™ Total Wrist System (K042032)

Submission Summary (Full Text)

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050028

12

MAR 25 2005

BIOMET

## 510(k) Summary

Applicant/Sponsor: Biomet Manufacturing Corp.

Contact Person: Patricia Sandborn Beres Senior Requlatory Specialist

Proprietary Name: Maestro™ Carpal HemiArthroplasty

Partial Wrist Joint Common Name:

Classification Name: Prosthesis, Wrist Carpal Lunate (21 CFR 888.3750 and/or Prosthesis, Wrist, Carpal Scaphoid (21 CFR 888.3760)

The Maestro™ Carpal HemiArthroplasty requires removal of both the lunate and the scaphoid bones therefore it does not clearly fit one classification

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Swanson Titanium Carpal Scaphoid Implant (Wright Medical Technologies) - K864490 Swanson Titanium Carpal Lunate Implant (Wright Medical Technologies) -

K864491

Maestro™ Total Wrist System (Biomet Manufacturing Corp.) - K042032

Device Description: The Maestro™ Carpal HemiArthroplasty is a three piece carpal component designed to articulate with the natural radial bone. The carpal component consists of 3 sub-components - a carpal head, a carpal plate and a capitate stem. The carpal head comes in 3 heights, standard, +2 and +4. This allows the surgeon to adjust for soft tissue laxity. Two lengths of carpal plates give the surgeon options of screw placement.

MAILING ADDRESS SHIPPING ADDRESS 56 E. Bell Drive P.O. Box 587 Warsaw, IN 46581 0587 Warsaw, IN 46582 ()FFICE ドAX 1 574.267 6639 574.267.8137

133

E-MAIL [e-mail]

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510(k) Summary Maestro™ Hemi-Wrist Page 2

lntended Use: The Maestro™ Carpal HemiArthroplasty is indicated for use as a replacement of wrist joints disabled by pain, deformity and/or limited motion caused by:

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KIDS 30 7 3

- 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 carpal bones

The device is intended to be implanted with bone cement.

Summary of Technologies: The overall design, materials, surface finishes and processing of the Maestro™ Carpal HemiArthroplasty are similar or identical to the predicate devices.

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

Clinical Testing: None provided

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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: K050028

Trade/Device Name: Maestro™ Carpal HemiArthroplasty Regulation Numbers: 21 CFR 888.3750, 21 CFR 888.3760 Regulation Names: Wrist joint carpal lunate polymer prosthesis, Wrist joint carpal scaphoid polymer prosthesis Regulatory Class: II Product Codes: KWN, KWN, KWO Dated: January 5, 2005 Received: January 6, 2005

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 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/industry/support/index.html.

Sincerely yours,

the Hype Purdu
Miriam C. Provost, Ph.D.

C. Provost, Ph.D Miriam Acting 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):

K050028

Device Name: Maestro TM Carpal HemiArthroplasty

Indications For Use: The Maestro™ Carpal HemiArthroplasty 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 carpal bones

The device is intended to be implanted with bone cement.

Prescription Use X (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)

Stupt Clurdes

Division of General, Restorative, and Neurological Devices

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