SBI RADIO-CAPITELLAR IMPLANT

K060038 · Small Bone Innovations, Inc. · JDB · Mar 30, 2006 · Orthopedic

Device Facts

• Record ID: K060038
• Device Name: SBI RADIO-CAPITELLAR IMPLANT
• Applicant: Small Bone Innovations, Inc.
• Product Code: JDB · Orthopedic
• Decision Date: Mar 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SBI Radio-Capitellar implant is indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease including osteo-arthritis or traumatic arthritis: 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments and devices have failed; and 5) treatment of fractures that are unmanageable using other techniques.

Device Story

The SBI Radio-Capitellar Implant is a semi-constrained, cemented elbow prosthesis designed as an alternative to hemi-arthroplasty of the proximal radial head. It is intended for use in conjunction with previously cleared radial stem components (rHead and rHead Recon). The device is implanted by a surgeon in a clinical setting to treat degenerative joint disorders or fractures. By replacing the radio-capitellar joint surface, the implant aims to reduce pain and restore elbow function, enabling patients to perform activities of daily living.

Clinical Evidence

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

Technological Characteristics

Materials: Cobalt chrome alloy and ultra-high molecular weight polyethylene (UHMWPE). Design: Semi-constrained, cemented elbow prosthesis. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients requiring elbow pain relief or improved function due to non-inflammatory degenerative joint disease (osteo-arthritis, traumatic arthritis), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity, failed prior treatments, or unmanageable fractures.

Regulatory Classification

Identification

An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow 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 consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• rHead (K011819)
• rHead Recon (K023604)

Submission Summary (Full Text)

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K060038 p.1/2

MAR 3 0 2006

# 510(k) Summary

| Manufacturer: | rms Company<br>8600 Evergreen Boulevard<br>Minneapolis, MN 55433<br>763-786-1520 - Office<br>763-783-5073 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Radio-Capitellar Implant |
| Classification name: | Class II, 888.3160 - Prosthesis, Elbow, Semi-Constrained,<br>Cemented |
| Common/Usual Name: | Elbow joint metal/polymer semi-constrained cemented<br>prosthesis |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBI<br>Radio-Capitellar Implant to be substantially equivalent to<br>other legally marketed devices. |
| Device Description: | The SBI Radio-Capitellar Implant provides an alternative<br>to hemi-arthroplasty of the proximal radial head. The<br>implant is used for the treatment of degenerative joint<br>disorders of the radio-capitellar joint allowing activities of<br>daily living to be performed with no or significantly<br>reduced pain. The radio-capitellar implant is designed to<br>be used with the radial stem components of the rHead and<br>rHead Recon stem implants cleared for market under<br>510(k) K011819 and K023604 respectively. |
| Intended Use: | The SBI Radio-Capitellar implant is indicated for use in the<br>elbow for reduction or relief of pain and/or improved elbow<br>function in skeletally mature patients with the following<br>conditions: 1) non-inflammatory degenerative joint disease<br>including osteo-arthritis or traumatic arthritis: 2) |

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inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments and devices have failed; and 5) treatment of fractures that are unmanageable using other techniques.

Material:

The SBI Radio-Capitellar implant is designed from implantable grades of cobalt chrome alloy and ultra-high molecular weight polyethylene (UHMWPE).

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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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 2006

Small Bone Innovations, Inc. c/o Mr. Robert Hoehn Regulatory Associate 505 Park Avenue - 14th Floor New York, New York 10022

Re: K060038

Trade/Device Name: SBI Radio-Capitellar Regulation Number: 21 CFR 888.3160 Regulation Name: Elbow joint metal/polymer semi-constrained cemented prothesis Regulatory Class: II Product Code: JDB Dated: December 15, 2005 Received: January 6, 2006

Dear Mr. Hoehn:

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

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### Page 2 -Mr. Robert Hoehn

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. 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 premiated noticated 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/dsma/dsmamain.html

Sincerely yours.

Hulut Lemus

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:

Device Name: SBI Radio-Capitellar

Indications For Use:

The SBI Radio-Capitellar implant is indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease including osteo-arthritis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments and devices have failed; and 5) treatment of fractures that are unmanageable using other techniques.

The Avanta Radio-Capitellar implant is intended for cemented use only.

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)

Herbert Lemar us

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Division of General, Restorative. and Neurological Devices

**510(k) Number** K060038