SBI ULNAR HEAD IMPLANT

K061146 · Small Bone Innovations, Inc. · KXE · Jul 19, 2006 · Orthopedic

Device Facts

• Record ID: K061146
• Device Name: SBI ULNAR HEAD IMPLANT
• Applicant: Small Bone Innovations, Inc.
• Product Code: KXE · Orthopedic
• Decision Date: Jul 19, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SBI Ulnar Head Implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic disabilities presenting the following; pain and weakness of the wrist joint not improved by conservative treatment, instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and failed ulnar head resection.

Device Story

SBI Ulnar Head Implant is a distal radioulnar joint prosthesis; used for replacement following ulnar head resection. Device addresses rheumatoid, degenerative, or post-traumatic disabilities; specifically pain, weakness, and instability. Sigmoid notch component used in conjunction to restore wrist function and forearm kinematics. Implanted by orthopedic surgeons in clinical/surgical settings. Provides mechanical replacement of the distal ulnar head to improve joint stability and reduce pain.

Clinical Evidence

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

Technological Characteristics

Implantable cobalt chrome (ASTM 1537-94) with CpTi coating. Hemi-wrist prosthesis design for distal radioulnar joint replacement.

Indications for Use

Indicated for patients with rheumatoid, degenerative, or post-traumatic disabilities of the distal radioulnar joint. Patient population presents with wrist pain/weakness unresponsive to conservative treatment, ulnar head instability with dorsal subluxation/erosive changes, or failed prior ulnar head resection.

Regulatory Classification

Identification

A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.

Predicate Devices

• uHead™ Ulnar Head Replacement (K010786)

Submission Summary (Full Text)

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K061146 (pg 1 of 2)

## 510(k) Summary

## JUL 1 9 2006

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| Manufacturer: | Small Bone Innovations<br>1711 South Pennsylvania Ave<br>Morrisville, PA 19067<br>215-428-1791 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Small Bone Innovations<br>James O' Connor<br>505 Park Avenue, 14th Floor<br>New York, NY 10022<br>[e-mail]<br>215-428-1791 - Office<br>212-750-2112 - Fax |
| Proprietary Name: | SBI Ulnar Head Implant |
| Classification name: | Class II, 888.3810 - Prosthesis, Wrist, Hemi-, Ulnar |
| Common/Usual Name: | Ulnar Head Implant |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBI<br>Ulnar Head Implant to be substantially equivalent to other<br>legally marketed devices. |
| Device Description: | The uHead™ Ulnar Head Replacement prosthesis is<br>currently approved under 510(k) K010786 and marketed by<br>Small Bone Innovations. This device is used to treat<br>patients with rheumatoid, degenerative, or post-traumatic<br>disabilities presenting the following; pain and weakness of<br>the wrist joint not improved by conservative treatment,<br>instability of the ulnar head with x-ray evidence of dorsal<br>subluxation and erosive changes, and failed ulnar head<br>resection. The sigmoid notch component is used in<br>conjunction with the uHead™ device. Dependent upon the<br>severity of degenerative joint disease and forearm stability,<br>the sigmoid notch component can be used to restore stabile<br>wrist function and improve forearm kinematics that is not<br>always obtainable with the uHead™ prosthesis alone. |
| Intended Use: | The SBI Ulnar Head Implant is intended for replacement of<br>the distal radioulnar joint following ulnar head resection<br>arthroplasty: Replacement of the distal ulnar head for<br>rheumatoid, degenerative, or post-traumatic disabilities<br>presenting the following; pain and weakness of the wrist<br>joint not improved by conservative treatment, instability of<br>the ulnar head with x-ray evidence of dorsal subluxation<br>and erosive changes, and failed ulnar head resection. |
| Material: | The SBI Ulnar Head Implant is designed from implantable<br>grades of cobalt chrome (ASTM 1537-94), with CpTi<br>coating. |

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KO61146 ( pg.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2006

Small Bone Innovations % Mr. James O'Connor VP, QA/QC & Regulatory Affairs 505 Park Avenue, 14th Floor New York, New York 10022

Re: K061146

Trade/Device Name: SBI Ulnar Head Implant Regulation Number: 21 CFR 888.3810 Regulation Name: Wrist joint ulnar (hemi-wrist) polymer prosthesis Regulatory Class: Class II Product Code: KXE Dated: June 13, 2006 Received: June 19, 2006

Dear Mr. O'Connor:

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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## Indications for Use

510(k) Number:

Device Name: SBI Ulnar Head Implant

Indications For Use:

The SBI Ulnar Head Implant is intended for replacement of the distal radiouinar joint following unar The SBI Unial Head Infont is intended for reprosition of the distal ulnar head for rheumatoid, degencrative, or posttraumatic disabilities presenting the following; pain and weakness of the wrist joint not improved by and or traumatic disabilities presenting the introwing, pain and with x-ray evidence of dorsal subluxation and erosive changes, and failed ulnar head resection.

Prescription Use V (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)

Page 1 of 1

Ambare Buchup

Division of General, Restorative, and Neurological Devices

510(k) Number K061146.