NEXA CARPO METACARPAL IMPLANT

K060386 · Nexa Orthopedics, Inc. · KYI · May 10, 2006 · Orthopedic

Device Facts

• Record ID: K060386
• Device Name: NEXA CARPO METACARPAL IMPLANT
• Applicant: Nexa Orthopedics, Inc.
• Product Code: KYI · Orthopedic
• Decision Date: May 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.

Device Story

Nexa carpometacarpal (CMI) implant; orthopedic prosthesis for thumb; replaces proximal end of first metacarpal. Implanted by orthopedic surgeons in clinical setting. Pyrocarbon construction. Addresses pain, instability, and limited range of motion resulting from arthritis or trauma. Surgical instruments provided for implantation. Device restores joint function; improves patient mobility.

Clinical Evidence

No clinical data provided; substantial equivalence based on design characteristics.

Technological Characteristics

Pyrocarbon material; 3 sizes; intended for implantation into the metacarpal of the thumb.

Indications for Use

Indicated for patients with rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post-fracture deformation/bone loss of the first metacarpal presenting with painful, unstable thumb or limited range of motion.

Regulatory Classification

Identification

A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.

Submission Summary (Full Text)

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K060386

#### 510 (k) Summary

| Prepared: | May 4, 2006 | MAY 10 2006 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------|
| Applicant: | Nexa Orthopedics, Inc.,<br>10675 Sorrento Valley Road, Suite 100<br>San Diego, CA 92121 | |
| Telephone: | 858-866-0660 | |
| Fax: | 858-866-0661 | |
| Contact: | Louise M. Focht | |
| Device Name: | Nexa carpometacarpal (CMI) implant | |
| Device Trade Name: | Nexa carpometacarpal (CMI) implant | |
| Device Classification: | Class II | |
| Reviewing Panel: | Orthopedic | |
| Regulation Number | 888.3770 | |
| Product Code: | 87 KYI | |
| Substantial Equivalence: | Documentation is provided which<br>demonstrated the device to be substantial<br>equivalent to other legally marketed<br>devices | |
| Registration Number: | 2030833 | |
| Owner Operator Number: | 9028319 | |

### Device Description:

The Nexa Orthopedics CMI implant and surgical instruments are provided in 3 sizes. The device is intended to be implanted into the metacarpal of the thumb. The device is made of pyrocarbon. No new materials are used in the development of this implant.

#### Indications for Use:

The device is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb with limited range of motion.

#### Summary:

The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 1 0 2006

Nexa Orthopedics, Inc. c/o Ms. Louise M. Focht Vice President of Research and Development 10675 Sorrento Valley Road, Suite 100 San Diego, California 92121

Re: K060386

Trade/Device Name: Nexa Carpo Metacarpal Implant (CMI) Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: Class II Product Code: KYI Dated: February 13, 2006 Received: February 14, 2006

Dear Ms. Focht:

We have reviewed your Section 510(k) premarket notification of intent to market the device w oneve to rowe 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

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# Page 2 - Ms. Louise M. Focht

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decisions over device as described in your Section 510(k)
This letter will allow you to begin marketing your device as described in your I his letter will anow you to begin marketing your as ratence of your device to a legally premarket notification. The PDA maing of backanner of 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 If you desire specific advice for your acon 2011-01-20120. Also, please note the regulation entitled, Contact the Office of Compunation at (210) 276 Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other geleral informational and Consumer Assistance at its toll-free number (800) 638-204 or Manufacturers, internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Haberleener co

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): KO60386 Device Name: Nexa Carpo Metacarpa

Indications for Use:

The device is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Steiner MD

Division of General, Restorative, and Neurological Devices

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