TAPERED COMPRESSION PIN

K051740 · Nexa Orthopedics, Inc. · JDW · Sep 6, 2005 · Orthopedic

Device Facts

• Record ID: K051740
• Device Name: TAPERED COMPRESSION PIN
• Applicant: Nexa Orthopedics, Inc.
• Product Code: JDW · Orthopedic
• Decision Date: Sep 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Futura Biomedical Tapered Compression Pin is intended to be implanted for the fixation of bone fractures, bone reconstruction, osteotomy or arthrodesis of the foot and ankle and hand and wrist.

Device Story

Tapered Compression Pin; one-piece metallic bone fixation fastener. Used for fracture fixation, bone reconstruction, osteotomy, or arthrodesis in foot, ankle, hand, and wrist. Implanted surgically by physicians. Device features tapered, threaded leading end and smooth trailing end; available in three sizes. Implanted using surgical instruments including k-wire, drill, pin cutter, pliers, and trephine. Provides mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: 316L Stainless Steel (ASTM F138) and Ti6Al4V Titanium Alloy (ASTM F136). Design: One-piece, tapered, threaded metallic bone fixation fastener. Sizes: 3 variants. Connectivity: None (mechanical implant). Sterilization: Not specified.

Indications for Use

Indicated for fixation of bone fractures, bone reconstruction, osteotomy, or arthrodesis in the foot, ankle, hand, and wrist. For prescription use.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Newdeal TAC pin (K993910)

Submission Summary (Full Text)

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# 510 (k) Summary

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

| Prepared: | August 8, 2005 |
|------------------------|------------------------------------------------------------------------|
| Applicant: | Futura Biomedical<br>990 Park Center Drive, suite H<br>Vista, CA 92081 |
| Telephone: | 760-599-1670 |
| Fax: | 760-599-1675 |
| Contact: | Louise M. Focht |
| Device Name: | Smooth or threaded metallic bone fixation fastener |
| Device Trade Name: | Tapered Compression Pin |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number | 888.3040 |
| Product Code: | 87 JDW |
| Predicate Device: | K993910 |
| Registration Number: | 2030833 |
| Owner Operator Number: | 9028319 |

### Device Description:

The Futura Biomedical Implant is a one-piece device made of Stainless Steel or Titanium Alloy, intended for fixation of bone fractures, bone reconstruction, osteotomy or Andy, intended 101 - 121 is designed in 3 sizes. The device is tapered and threaded on the leading end and smooth on the trailing end. The implant is used in the treatment or the feactures of bone reconstruction, including osteotomy, and joint fusion. The design of the Futura Biomedical Tapered Pin is similar in shape and size to the Newdeal TAC of the Patare Dietices consist of a tapered, threaded pin that fits into a pin driver. Surgical instruments include a k-wire, drill, pin cutter, pliers, and trephine. No new materials are used in the development of this implant.

## Indications for Use:

The Futura Biomedical Tapered Compression Pin is intended to be implanted for the fixation of bone fractures, bone reconstruction, osteotomy or arthrodesis of the foot and ankle and hand and wrist.

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# Comparison to Predicate Device:

The legally marketed predicate device to which this device is substantially equivalent is the Newdeal TAC pin.

Regulatory Class: II 87 JDW Product Code:

Comparison of Futura Biomedical and Newdeal Products

| Item | Futura Product | Newdeal Product |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Tapered Compression Pin | TAC pin |
| Use | Single use | Single use |
| Fixation | Bone | Bone |
| Material | 316L Stainless Steel, ASTM F138<br>Ti6Al4V, ASTM F136<br>Titanium Alloy | Ti6Al4V, ASTM F136<br>Titanium Alloy |
| Sizes | 3 Sizes | 3 Sizes |
| Diameter | 2.0, 2.7, 3.0 mm | 1.6 mm |
| Length | overall length 80mm<br>thread length (.59, .79, .98 in) | Overall length 3.75"<br>thread length (15, 20, 25 mm) |
| Indications for use | The Futura Biomedical Tapered<br>Compression Pin is intended to be implanted<br>for the fixation of bone fractures, bone<br>reconstruction, osteotomy or arthrodesis of<br>the foot and ankle and hand and wrist. | The TAC pin is indicated for synthesis of<br>small bone fragments in the foot only.<br>Examples include:<br>Akin type osteotomy<br>First MP arthrodesis<br>Phalangeal arthrodesis<br>Small bones osteosynthesis requiring<br>compression |

Similarities of the Futura Biomedical Tapered Compression Pin and the Newdeal TACpin include:

Both devices are: intended for single use only; intended for surgical implantation longer than 30 days; both devices are placed into bone, for fracture repair, bone reconstruction, osteotomy, or arthrodesis, both devices are threaded, no new materials are introduced in the product; Both devices are comparably sized; both devices have the same indications 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2005

Ms. Louise M. Focht Futura Biomedical 990 Park Center Drive, Suite H Vista, California 92081

Re: K051740

Trade/Device Name: Tapered Compression Pin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW Dated: June 27, 2005 Received: June 28, 2005

Dear Ms. Focht:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section of the device is substantially equivalent (for the indications ferenced above and have asien legally marketed predicate devices marketed in interstate 10 use stated in the encrosaly to togains and the Medical Device Amendments, or to commerce program to May 20, 1978, in ecordance with the provisions of the Federal Food, Drug, devices that have been roomsoned require approval of a premarket approval application (PMA). alla Cosmeter rece (110) that do not required to the general controls provisions of the Act. The r ou may, dierefore, manel of the Act include requirements for annual registration, listing of general controls provision 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to suen additions, 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 r lease be advised that i Dr bration that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must of any I ederal station and 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 forum in the quart) of eventsions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Ms. Louise M. Focht

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse of substantial equivalence of your device to a legally prematics notification. "The 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 if you desire 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 other general 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,

Signature

్లీని Mark N. Melkerson Acting 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 (if known): _KO51740 Device Name: Tapered Compression Pin Indications for Use:

The Futura Biomedical Tapered Compression Pin is intended to be implanted for the The Futura Diomedian Taperor Construction, osteotomy or arthrodesis of the foot and ankle and hand and wrist.

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

Signature

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________