CLASSIC GREAT TOE IMPLANT

K023086 · Nexa Orthopedics, Inc. · KWH · Oct 4, 2002 · Orthopedic

Device Facts

• Record ID: K023086
• Device Name: CLASSIC GREAT TOE IMPLANT
• Applicant: Nexa Orthopedics, Inc.
• Product Code: KWH · Orthopedic
• Decision Date: Oct 4, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Futura Biomedical Classic Great Toe Implant is indicated for: - Hallux limitus or hallux rigidus . - . Painful rheumatoid arthritis - Hallux abducto valgus associated with arthritis ● - Unstable or painful joint from previous surgery .

Device Story

Classic Great Toe Implant is a double-stemmed silicone prosthesis; functions as a dynamic joint spacer for first metatarsophalangeal joint arthroplasty. Implanted surgically by physician; stems placed into intramedullary canals of metatarsal and proximal phalanx. Device provides constrained joint support; intended for long-term implantation (>30 days). Benefits include pain relief and joint stabilization for patients with degenerative or post-surgical toe conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparison to predicate device.

Technological Characteristics

Double-stemmed silicone prosthesis; constrained design; four sizes (20, 30, 40, 50); intended for intramedullary canal fixation.

Indications for Use

Indicated for patients with hallux limitus, hallux rigidus, painful rheumatoid arthritis, hallux abducto valgus associated with arthritis, or unstable/painful joints resulting from previous surgery.

Regulatory Classification

Identification

A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.

Predicate Devices

• Futura Biomedical Flexible Great Toe Implant (k981194)

Submission Summary (Full Text)

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# OCT 0 4 2002

## 510 (k) Summary

Summary of 510 (k) safety and effectiveness information upon which the subs determination is based:

| Prepared: | September 13, 2002 |
|-----------|--------------------|
|-----------|--------------------|

- Futura Biomedical Applicant: 990 Park Center Drive, Suite H Vista, CA 92083

| Telephone: | 760-599-1670 |
|------------|-----------------|
| Fax: | 760-599-1675 |
| Contact: | Louise M. Focht |

| Device Name: | Prosthesis, Toe, Constrained, Polymer |
|----------------------------|---------------------------------------------------------|
| Device Trade Name: | Classic Great Toe Implant |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number | 888.3720 |
| Product Code: | 87 KWH |
| Original Predicate Device: | Futura Biomedical Flexible Great Toe<br>Implant-k981194 |
| Registration Number: | 2030833 |
| Owner Operator Number: | 9028319 |

#### Device Description:

The Classic Great Toe Implant is a double-stemmed silicone prosthesis, intended to supplement first metatarsophalangeal joint srthroplasty. The implant is designed to act as a dynamic joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

## Indications for Use:

Futura Biomedical Classic Great Toe Implant is indicated for:

- Hallux limitus or hallux rigidus .
- . Painful rheumatoid arthritis
- Hallux abducto valgus associated with arthritis ●
- Unstable or painful joint from previous surgery .

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Comparison to the Original Predicate Device:

The legally marketed predicate device to which this device is substantially equivalent is the Futura Biomedical Flexible Great Toe Implant

Regulatory Class: II Product Code: 87 KWH

Comparison of original Futura Biomedical Flexible Great Toe Implant to the new configuration the Classic Great Toe Implant.

| Item | Original Futura Product | Proposed product configuration |
|---------------------|----------------------------------------------------|----------------------------------------------------|
| Product Name | Flexible Great Toe Implant | Classic Great Toe Implant |
| Use | Single use | Single use |
| Fixation | Stem in intramedullary canal | stem in intramedullary canal |
| Constraint | constrained | constrained |
| Material | Silicone | Silicone |
| Sizes | 4 sizes, 20, 30, 40, 50 | 4 sizes 20, 30, 40, 50 |
| Indications for use | Hallux limitus or hallux rigidus | Hallux limitus or hallux rigidus |
| | Painful rheumatoid arthritis | Painful rheumatoid arthritis |
| | Hallux abducto valgus associated<br>with arthritis | Hallux abducto valgus associated<br>with arthritis |
| | Unstable or painful joint from<br>previous surgery | Unstable or painful joint from<br>previous surgery |

Similarities of the Futura Flexible Great Toe Implant and Classic Great Toe Implant include; Both devices are intended for single use only; Both devices are intended for surgical implantation longer than 30 days; Both devices are placed into the intramedullary canal of the metatarsal and phalangeal bones; Both devices are made of the same industry standard materials. No new materials are introduced in either product; Both devices are comparably sized; Both devices have the identical for use.

## Summary:

The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, stacked vertically.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 4 2002

Mr. Louise M. Focht Futura Biomedical 990 Park Center Drive, Suite H Vista, California 92083

Re: K023086 Trade Name: Classic Great Toe Implant Regulation Number: 21 CFR 888.3720 Regulation Name: Toe joint polymer constrained prosthesis Regulatory Class: II Product Code: KWH Dated: September 13, 2002 Received: September 17, 2002

Dear Mr. Focht:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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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Page 2 - Mr. Louise M. Focht

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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,

Q. Mark N. Millbern

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510 (k) Number (If Known):_ Device Name: Classic Great Toe Implant

# Indications for Use:

Futura Biomedical Classic Great Toe Implant is indicated for:

- Hallux limitus or hallux rigidus .
- Painful rheumatoid arthritis ●
- Hallux abducto valgus associated with arthritis ●
- Unstable or painful joint from previous surgery ●

Prescription Use

Yes/No

Or

Over the counter use

Yes/No

Mark A. Milken

(Division Sign-Of Division of General in storative and Neurological L . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5. Number K023086