SBI SR MTP TOE IMPLANT

K073635 · Small Bone Innovations, Inc. · KWD · Mar 19, 2008 · Orthopedic

Device Facts

• Record ID: K073635
• Device Name: SBI SR MTP TOE IMPLANT
• Applicant: Small Bone Innovations, Inc.
• Product Code: KWD · Orthopedic
• Decision Date: Mar 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SBi SR MTP Toe Implant is intended for use as a hemi-arthroplasty implant for the metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The SBi SR MTP Toe Implant is intended for implantation with and without bone cement.

Device Story

SBi SR MTP Toe Implant; one-piece, stemmed hemi-arthroplasty device for metatarsophalangeal (MTP) joint. Replaces articulating surface of metatarsal head. Features include posteriorly extending articulating surface and barbed stem for fixation. Implanted by orthopedic surgeons in clinical/surgical settings. Used with or without bone cement. Provides structural replacement to restore joint function, reduce pain, and address deformities like hallux valgus/rigidus.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Wrought CoCrMo alloy (ASTM F1587) with commercially pure titanium plasma coating (ASTM F1580). One-piece stemmed design with barbed stem for fixation. Non-software device.

Indications for Use

Indicated for patients requiring hemi-arthroplasty of the metatarsophalangeal (MTP) joint due to degenerative arthritis, post-traumatic arthritis, hallux valgus, hallux rigidus, or unstable/painful MTP joint.

Regulatory Classification

Identification

A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.

Submission Summary (Full Text)

{0}------------------------------------------------

MAR 1 9 2008

K073 635

1 +2

## 2. 510(k) Summary

| Manufacturer: | Small Bone Innovations, Inc.<br>1380 South Pennsylvania Avenue<br>Morrisville, PA 19067 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Small Bone Innovations, Inc.<br>1380 South Pennsylvania Avenue<br>Morrisville, PA 19067 |
| Contact: | Jeff Zigler<br>Musculoskeletal Clinical Regulatory Advisers, LLC<br>(MCRA)<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>202.552.5800 |
| Proprietary Name: | SBi SR MTP Toe Implant |
| Classification name: | Class II, 21 CFR 888.3730 - Toe joint phalangeal (hemi-<br>toe) polymer prosthesis |
| Common/Usual Name: | Toe joint, phalangeal (hemi-toe) prosthesis |
| Product Code: | KWD |
| Substantial Equivalence: | Documentation was provided which demonstrated the SBi<br>SR MTP Toe Implant is substantially equivalent to other<br>legally marketed devices. |
| Device Description: | The SBi SR MTP Toe Implant is a one-piece, stemmed<br>device intended to replace the articulating surface of the<br>metatarsal at the MTP joint. The implant is available in a<br>range of sizes to match the geometry of the metatarsal<br>head. Design features include an articulating surface which<br>extends posteriorly on the superior side of the implant and a<br>gently barbed stem to improve fixation in the metatarsal. |
| Intended Use: | The SBi SR MTP Toe Implant is intended for use as a<br>hemi-arthroplasty implant for the metatarsophalangeal<br>joint, for the treatment of degenerative and post-traumatic<br>arthritis, hallux valgus, hallux rigidus, and an unstable or<br>painful metatarsophalangeal (MTP) joint. |

{1}------------------------------------------------

K073635 pg 2 of 2

The SBi SR MTP Toe Implant is intended for implantation with and without bonc cement.

The implants are made from wrought CoCrMo alloy Materials: (ASTM F1587) with a plasma coating comprised of commercially pure titanium (ASTM F1580).

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

MAR 1 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Small Bone Innovations, Inc % Mr. Jeffrey Zigler Musculoskeletal Clinical Regulatory Advisors, LLC 1331 H Street, NW, 12th Floor Washington, DC 20005

Re: K073635 Trade/Device Name: SBi SR MTP Toe Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II Product Code: KWD Dated: December 21, 2007 Received: December 26, 2007

Dear Mr. Zigler:

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.

{3}------------------------------------------------

## Page 2 - Mr. Jeffrey Zigler

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Mark M. Milkus

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

Enclosure

{4}------------------------------------------------

## Indications for Use -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

510(k) Number (if known): K073635

Device Name: SBi SR MTP Toe Implant

The SBi SR MTP Toe Implant is intended for use as a hemi-arthroplasty implant for the metatarsophalangeal joint, for the treatment of degenerative and posttraumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint.

The SBi SR MTP Toe Implant is intended for implantation with and without bone cement.

Prescription Use N (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)

Sutte
(Division Sign-Off)

Division of General, Restorative, and Networkigheal Devices

510(k) Number K073635

Page 5 of 11