BIOPRO HEMI-EDGE TOE SYSTEM

K121973 · Biopro, Inc. · KWD · Oct 30, 2012 · Orthopedic

Device Facts

• Record ID: K121973
• Device Name: BIOPRO HEMI-EDGE TOE SYSTEM
• Applicant: Biopro, Inc.
• Product Code: KWD · Orthopedic
• Decision Date: Oct 30, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A press fit implant for arthritic degradation of the metatarso-phalangeal joint that has resulted in disabling pain, limited motion and loss of the normal ambulatory function of the forefoot. Degenerative arthritis. Rheumetoid arthritis. Bunion deformity associated with arthritis of the metatarsal-phalangeal joint. A titanium version is available for use only in patients susceptible to nickelchromium allergies. The BioPro Hemi-Edge Toe System is not intended for spinal use.

Device Story

BioPro Hemi-Edge Toe System is a hemi-phalangeal toe prosthesis designed for surgical implantation in the metatarso-phalangeal joint. The device features a contoured articulating surface to simulate the proximal phalanx and a diamond-shaped stem for press-fit intra-medullary fixation. A modification to the original design includes a partial surrounding lip/rim to prevent osteophyte bone on-growth; two windows in the rim allow for visual or needle verification of seating on resected bone. Available in five sizes, in porous or non-porous coated versions, manufactured from Cobalt Chrome or Titanium 6-4. The device is intended for use by surgeons in a clinical setting to restore joint function and alleviate pain associated with arthritis. It is supplied sterile for single-use via ethylene oxide sterilization.

Clinical Evidence

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

Technological Characteristics

Materials: Cobalt Chrome (ASTM F1537) or Titanium 6-4 (ASTM F1472). Design: Press-fit intra-medullary fixation with diamond-shaped stem; contoured articulating surface with partial lip/rim and seating verification windows. Sterilization: Ethylene Oxide. Single-use, sterile.

Indications for Use

Indicated for patients with arthritic degradation of the metatarso-phalangeal joint causing disabling pain, limited motion, and loss of forefoot ambulatory function. Includes degenerative arthritis, rheumatoid arthritis, and bunion deformity with arthritis. Titanium version indicated for patients with nickel-chromium allergies. Not for spinal use.

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.

Predicate Devices

• BioPro Hemi MP Joint (K041595)
• Townley Great Toe Joint (K911378)

Reference Devices

• Giza E, Sullivan MR. First Metatarsophalangeal Hemiarthroplasty for Grade III and IV Hallux Rigidus. Techniques in Foot and Ankle Surgery. 2005.
• Townley CO, Taranow WS. A Metallic Hemiarthroplasty Resurfacing Prosthesis for the Hallux Metatarsophalangeal Joint. Foot & Ankle International. 1994.

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

OCT 3 1 2012

# SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary

| NAME OF FIRM: | BioPro, Inc.<br>2929 Lapeer Road<br>Port Huron, MI 48060 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) FIRM CONTACT: | Al Lippincott<br>Engineering Consulting Services, Inc.<br>3150 E. 200th St.<br>Prior Lake, MN 55372<br>Tel. No. 952-492-5858<br>e-mail: [e-mail] |
| DATE: | June 22, 2012 |
| TRADE NAME: | BioPro Hemi-Edge Toe System |
| COMMON NAME: | Prosthesis, Toe, Hemi, Phalangeal |
| CLASSIFICATION: | Toe joint phalangeal (hemi-toe) prosthesis (21CFR, Sec. 888.3730 |
| DEVICE PRODUCT CODE: | KWD |

SUBSTANTIALLY EQUIVALENT DEVICES

· BioPro Hemi MP Joint (K041595) Townley Great Toe Joint (K911378)

· DEVICE DESCRIPTION:

The BioPro Hemi-Edge Toe System will be available in two material options: it can be manufactured from either Cobalt Chrome (ASTM F1537) or Titanium 6-4 (ASTM F1472). The system will be available in 5 sizes in both porous and non-porous coated versions as a press fit design. The basic implant design is unchanged to the original design which consists of a contoured articulating surface to simulate the normal concave articulation of the proximal phalanx in the toe. 12 The current implant is a modification to the original implant design which includes a partial surrounding lip or rim adjacent the outer perimeter of the articulating surface. The purpose of the lip/rim is to prevent osteophyte bone on-growth to the articular surface that could inhibit function of the device. Two(2) small windows in opposite comers of the lip/rim allow either visual or needle verification in seating of the prosthesis on resected bone. The current implant design still includes the diamond shaped stem which provides a press-fit intra-medullary fixation. Ancillary instrumentation is available for device implantation and removal. The implant is sold in a 'sterile' condition for single-use. The sterilization method used is Ethylene Oxide.

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#### INTENDED USE:

- i. A press fit implant for arthritic degradation of the metatarso-phalangeal joint that has resulted in disabling pain, limited motion and loss of the normal ambulatory function of the forefoot.
- ii. Degenerative arthritis
- iii. Rheumetoid arthritis
- iv. Bunion deformity associated with arthritis of the metatarsal-phalangeal joint
- v. A titanium version is available for use only in patients susceptible to nickelchromium allergies.

The BioPro Hemi-Edge Toe System is not intended for spinal use.

EQUIVALENCE:

The BioPro Hemi-Edge Toe System is Substantially Equivalent(SE) to the predicate systems. No nonclinical testing was used in the determination of substantial equivalence.

### SUMMARY OF TECH-NOLOGICAL CHAR-ACTERISTICS

The BioPro Hemi-Edge Toe System is Similar in Material, Geometry Design/Markings, and Indications to the predicate system(s) currently sold in the U.S. market.

### SUMMARY OF SAFETY AND EFFECTIVENESS:

The BioPro Hemi-Edge Toe System is shown to be safe and effective for use as 'sterile' and for single-use in a surgical setting.

#### Cited References:

1. Giza E, Sullivan MR. First Metatarsophalangeal Hemiarthroplasty for Grade III and IV Hallux Rigidus. Techniques in Foot and Ankle Surgery. 4(1):10-17, 2005.

2. Townley CO, Taranow WS. A Metallic Hemiarthroplasty Resurfacing Prosthesis for the Hallux Metatarsophalangeal Joint. Foot & Ankle International. 1994;15(11):575-80.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The background is white.

#### Public Health Service.

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

OCT 3 1 2012

BioPro, Incorporated % Engineering Consulting Services, Incorporated Mr. Al Lippincott Medical Engineer and Consultant 3150 East 200th Street Prior Lake, Minnesota 55372

Re: K121973

Trade/Device Name: BioPro Hemi-Edge Toe System Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: KWD Dated: October 10, 2012 Received: October 18, 2012

Dear Mr. Lippincott:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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# Page 2 - Mr. Al Lippincott

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson
Director
Division of Surgical, Orthopedic

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:

# DEVICE NAME: BioPro Hemi-Edge Toe System

- A press fit implant for arthritic degradation of the metatarso-phalangeal joint that has resulted a. in disabling pain, limited motion and loss of the normal ambulatory function of the forefoot.
- Degenerative arthritis b.
- Rheumetoid arthritis C.
- Bunion deformity associated with arthritis of the metatarsal-phalangeal joint d.
- A titanium version is available for use only in patients susceptible to nickel chromium e. allergies.

The BioPro Hemi-Edge Toe System is not intended for spinal use.

AND/OR Over-The-Counter-Use _ Prescription Use XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

ivision Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

KINGZZ 510(k) Number