EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS

K092548 · Extremity Medical, LLC · KYI · Dec 15, 2009 · Orthopedic

Device Facts

• Record ID: K092548
• Device Name: EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS
• Applicant: Extremity Medical, LLC
• Product Code: KYI · Orthopedic
• Decision Date: Dec 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Extremity Medical Trapezium Prosthesis is indicated for use in degenerative or posttraumatic (e.g. following an old Bennett fracture) disabilities of the thumb basal joint with: - Localized pain and palpable crepitation at the base of the thumb on the "grind test" (circumduction with axial compression of the thumb) - Decreased motion, pinch, and grip strength - X-ray evidence of arthritic changes of the trapeziometacarpal, trapezioscaphoid, trapeziotrapezoid, and trapezium-second metacarpal joints, singly or in combination. - Associated unstable, stiff, or painful distal joints of thumb or swan neck deformity

Device Story

The Extremity Medical Trapezium Prosthesis is an orthopedic implant designed to replace the carpal trapezium bone in the thumb basal joint. It is intended for surgical implantation by a physician to address degenerative or post-traumatic joint disabilities. By replacing the damaged trapezium, the device aims to restore joint function, reduce pain, and improve pinch and grip strength in patients suffering from arthritis or joint instability. The device is used in a clinical/surgical setting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material similarity to legally marketed predicate devices.

Technological Characteristics

The device is a carpal trapezium polymer prosthesis. It shares similar design and material composition with the cited predicate devices.

Indications for Use

Indicated for patients with degenerative or post-traumatic thumb basal joint disabilities, including those with prior Bennett fractures, presenting with localized pain, crepitation, reduced motion/strength, and radiographic arthritic changes in the trapeziometacarpal, trapezioscaphoid, trapeziotrapezoid, or trapezium-second metacarpal joints, with or without associated distal thumb joint instability or swan neck deformity.

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.

Predicate Devices

• Wright Medical, Metallic CMC Spherical Implant (K960534)
• Wright Medical, Orthosphere Ceramic Spherical Implant (K030319)
• Wright Medical, Swanson Titanium Carpal Scaphoid Implant (K864490)
• Wright Medical, Swanson Titanium Carpal Lunate Implant (K864491)
• Wright Medical, TIE-IN Trapezium (K033529)
• Wright Medical, Trapezium Implant (K781756)
• Ascension Orthopedics, PyroSphere (K042690)
• Ascension Orthopedics, PyroCarbon Lunate (K080997)

Submission Summary (Full Text)

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K092548 1/2

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# DEC 1 5 2009

## 510(k) Summary of Safety and Effectiveness:

### EXTREMITY MEDICAL Implant System

| Submitter: | EXTREMITY MEDICAL LLC |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 300 Interpace Parkway |
| | Suite 410 |
| | Parsippany, NJ 07054 |
| Contact Person | Jamy Gannoe |
| | President |
| | Phone: [phone] |
| | Email: [e-mail] |
| Date Prepared | August 18, 2009 |
| Trade Name | EXTREMITY MEDICAL Trapezium Prosthesis |
| Classification Name<br>and Number | 21 CFR 888.3770 |
| Product Code | KYI |
| Predicate Devices | Wright Medical, Metallic CMC Spherical Implant K960534 |
| | Wright Medical, Orthosphere Ceramic Spherical Implant, |
| | K030319 |
| | Wright Medical, Swanson Titanium Carpal Scaphoid Implant, |
| | K864490 |
| | Wright Medical, Swanson Titanium Carpal Lunate Implant, |
| | K864491 |
| | Wright Medical, TIE-IN Trapezium, K033529 |
| | Wright Medical, Trapezium Implant, K781756 |
| | Ascension Orthopedics, PyroSphere, K042690 |
| | Ascension Orthopedics, PyroCarbon Lunate, K080997 |
| Device Description | The EXTREMITY MEDICAL Trapezium Prosthesis |
| Indications for use | The Extremity Medical Trapezium Prosthesis is indicated for<br>use in degenerative or post-traumatic (e.g. following an old<br>Bennett fracture) disabilities of the thumb basal joint with:<br>- Localized pain and palpable crepitation at the base of the<br>thumb on the "grind test" (circumduction with axial<br>compression of the thumb)<br>- Decreased motion, pinch, and grip strength<br>- X-ray evidence of arthritic changes of the trapeziometacarpal,<br>trapezioscaphoid, trapeziotrapezoid, and trapezium-second<br>metacarpal joints, singly or in combination.<br>- Associated unstable, stiff, or painful distal joints of thumb or<br>swan neck deformity |
| Statement of<br>Technological<br>Comparison | The EXTREMITY MEDICAL Trapezium Prosthesis and its<br>predicate devices have a similar design, and are made of the<br>similar materials. |
| Conclusion | The EXTREMITY MEDICAL Trapezium Prosthesis is<br>substantially equivalent to its predicate devices. This<br>conclusion is based upon the fact that this device is substantially<br>equivalent in terms of indications for use, materials, design and<br>principles of operation. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above three wavy lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

DEC 1 5 2009

EXTREMITY MEDICAL LLC % Mr. Jamy Gannoe 300 Interpace Parkway Suite 410 Parsippany, NJ 07054

Re: K092548

Trade/Device Name: Extremity Medical Trapezium Prosthesis Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: II Product Code: K.YI Dated: November 19, 2009 Received: November 23, 2009

Dear Mr. Gannoe:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 – Mr. Jamy Gannoe

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Jonita Js

Image /page/3/Picture/5 description: This image contains a handwritten symbol that appears to be a combination of a lowercase letter 'g' and a superscript 'n'. The 'g' is written in a cursive style, with a loop at the top and a tail extending downwards. The 'n' is smaller and positioned above and to the right of the 'g', indicating it may be a superscript or an abbreviation. The symbol is presented in black against a white background.

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): KO925 48

EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS Device Name: Indications for Use:

The Extremity Medical Trapezium Prosthesis is indicated for use in degenerative or posttraumatic (e.g. following an old Bennett fracture) disabilities of the thumb basal joint with:

- Localized pain and palpable crepitation at the base of the thumb on the "grind test" -(circumduction with axial compression of the thumb)
- -Decreased motion, pinch, and grip strength
- X-ray evidence of arthritic changes of the trapeziometacarpal, trapezioscaphoid, trapeziotrapezoid, and trapezium-second metacarpal joints, singly or in combination.
- Associated unstable, stiff, or painful distal joints of thumb or swan neck deformity

Over-the-counter Prescription Use X_ AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anita for MXM
Division Signoff

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510(k) Number K092578