FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT

K981194 · Nexa Orthopedics, Inc. · KWH · Jun 30, 1998 · Orthopedic

Device Facts

• Record ID: K981194
• Device Name: FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT
• Applicant: Nexa Orthopedics, Inc.
• Product Code: KWH · Orthopedic
• Decision Date: Jun 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Flexible Great Toe implant is a double-stemmed silicone prosthesis to supplement first metatarsophalangeal joint arthroplasty. The implant is designed to act as a dynamic joint spacer between the head of the 1st metatarsal and base of the proximal phalanx. A grommet option is offered for surgeons who choose to utilize grommets in their surgical procedure.

Device Story

Double-stemmed silicone prosthesis; acts as dynamic joint spacer for first metatarsophalangeal joint arthroplasty. Features hinged midsection; optional titanium press-fit grommets. Angled hinge block maintains flexor hallucis brevis tendon insertion; reduces metatarsal head resection to mitigate sesamoid impingement. Tapered stems and implant face geometry match resected proximal phalanx and metatarsal faces. Used by surgeons in clinical settings to treat hallux conditions and joint instability. Provides mechanical joint spacing to alleviate pain and restore function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Double-stemmed silicone implant with hinged midsection. Optional unalloyed titanium grommets (ASTM F67). Tapered stem geometry. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients with hallux limitus, hallux rigidus, painful rheumatoid arthritis, hallux abducto valgus associated with arthritis, or unstable/painful joint 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

• Swanson Flexible Hinge Toe Implant (K780132)

Submission Summary (Full Text)

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JUN 3 0 1998

Image /page/0/Picture/1 description: The image shows the logo for Futura Biomedical, with the words "FUTURA" and "BIOMEDICAL" stacked on top of each other. To the left of the text is a black square with a white shape inside. To the right of the logo, there is a handwritten "K981".

## 510(k) Summary

Submitted by:

Jamal D. Rushdy (Point of Contact) Futura Biomedical, L.L.C. 9369 Carroll Park Drive, Suite A San Diego, CA 92121 [phone] [phone] facsimile

Date of preparation: March 30, 1998

March 30, 199

Trade Name: Futura Biomedical Flexible Great Toe Implant

Common Name:

Flexible Great Toe Implant

Classification Name:

Constrained Polymer Toe Prosthesis per 888.3720 (Class II)

Substantially Equivalent to (predicate device):

Swanson Flexible Hinge Toe Implant by Dow Corning, 510(k) number K780132 (now offered by Wright Medical Technology, Inc., Arlington, TN).

Description/Intended Use:

The Flexible Great Toe implant is a double-stemmed silicone prosthesis to supplement first metatarsophalangeal joint arthroplasty. The implant is designed to act as a dynamic joint spacer between the head of the 1st metatarsal and base of the proximal phalanx. A grommet option is offered for surgeons who choose to utilize grommets in their surgical procedure. This is consistent with the description and intended use of the Swanson Flexible Hinge Toe Implant.

Indications for use of this implant are:

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

Technological Characteristics:

The Futura Flexible Great Toe and Predicate device are double-stemmed, silicone implants with a hinged midsection. They both offer titanium press fit grommets.

The angled hinge block of the Flexible Great Toe allows for the normal anatomic insertion of the flexor hallucis brevis tendon to be maintained and removes less of the inferior aspect of the metatarsal head to mitigate sesamoid impingement. The tapered stems and implant face are designed based on the geometry of the resected faces of the proximal phalanx and metatarsal.

There are currently no performance standards for great toe silicone joint implants. The American Society for Testing of Materials (ASTM) has developed voluntary standards for the materials used in the grommets:

F 67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications

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Image /page/1/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 featuring three stylized human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 1998

Mr. Jamal D. Rushdy General Manager Futura Biomedical, L.L.C. 9369 Carroll Park Drive, Suite A San Diego, California 92121

K981194 Re: Flexible Great Toe Implant Trade Name: Regulatory Class: II Product Code: KWH Dated: March 30, 1998 Received: April 2, 1998

Dear Mr. Rushdy:

We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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## Page 2 - Mr. Jamal D. Rushdy

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Whitton, Ph.D., M.D.

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

Enclosure

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## Statement of Indications for Use

K98/194 510(k) Number:

Device Name: Flexible Great Toe

Indications for Use:

and the considerary

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﺎ

| Prescription Use<br>(Per 21 CFR 801.109) | X |
|------------------------------------------|------------------------|
| OR | Over-The-Counter-Use _ |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | 2981194 |