NEXFIX COMPRESSION PIN

K072710 · Nexa Orthopedics, Inc. · JDW · Nov 8, 2007 · Orthopedic

Device Facts

• Record ID: K072710
• Device Name: NEXFIX COMPRESSION PIN
• Applicant: Nexa Orthopedics, Inc.
• Product Code: JDW · Orthopedic
• Decision Date: Nov 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NexFix™ 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

NexFix™ Compression Pin is a one-piece metallic bone fixation fastener; used for bone fractures, reconstruction, osteotomy, or arthrodesis. Device features tapered, threaded leading end and smooth trailing end; available in 10 sizes. Implanted surgically by physicians in clinical settings. Provides mechanical compression and stabilization of bone segments to facilitate healing. No electronic components, software, or AI/ML algorithms involved.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Materials: Stainless Steel or Titanium Alloy. Design: One-piece, tapered, threaded leading end, smooth trailing end. Sizes: 10 variations. Energy source: None (mechanical). Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring fixation of bone fractures, bone reconstruction, osteotomy, or arthrodesis in the foot, ankle, hand, or wrist.

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

• Tapered Compression Pin (K051740)
• TAC Pin, Newdeal (K993910)

Submission Summary (Full Text)

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K072710

# 510(k) Summary as required by section 807.92(c)

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

| Prepared: | September 24, 2007 |
|-----------------------------|-------------------------------------------------------------------------------------------|
| Applicant: | Nexa Orthopedics, Inc<br>a Tornier Company<br>11035 Roselle Street<br>San Diego, CA 92121 |
| Telephone: | 858-866-0660 × 155 |
| Fax: | 858-866-0661 |
| Contact: | Corey Wilson-Wirth |
| Common Name: | Threaded pin |
| Device Trade Name: | NexFix™ Compression Pin |
| Device Classification Name: | Smooth or threaded metallic bone fixation<br>fastener |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number: | 888.3040 |
| Product Code: | 87 JDW |
| Predicate Device: | K051740, Tapered Compression Pin<br>Futura Biomedical<br>K993910 TAC Pin, Newdeal |
| Registration Number: | 2030833 |
| Owner Operator Number: | 9100540 |

#### Device Description:

The Nexa Orthopedics, Inc Implant is a one-piece device made of Stainless Steel or Titanium Alloy, intended for fixation of bone fractures, bone reconstruction, osteotomy or arthrodesis. The implant is designed in 10 sizes. The device is tapered and threaded on the leading end and smooth on the trailing end. The implant is used in the treatment of bone fractures or bone reconstruction, including osteotomy, and joint fusion. The design of the NexFix™ Compression Pin is similar to the predicate devices. No new materials or processes are used in the development of this implant.

#### Indications for Use:

The NexFix™ 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:

Similarities of the NexFix Compression Pin to its predicates include these devices being: intended for single use only, intended for surgical implantation longer than 30 days, system consisting of a series of pins or various diameters and thread lengths, made of industry standard materials, with no new materials being introduced in the product, comparably sized, and indicated for the same uses.

## Summary:

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

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 8 2007

Nexa Orthopedics, Inc. a Tornier Company % Mr. Corey Wilson-Wirth 11035 Roselle Street San Diego. CA 92121

Re: K072710

Trade/Device Name: NexFix™ Compression Pin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW Dated: September 24, 2007 Received: September 25, 2007

Dear Mr. Wilson-Wirth:

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.

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## Page 2 - Mr. Corey Wilson-Wirth

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 the reporting 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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Varbara Buelup
Jos

Mark N. Melk 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): K072710 Device Name: NexFix™ Compression Pin Indications for Use:

The NexFix™ 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.

Prescription Use X Over-The-Counter 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

farbare Brien

Offision Sign-(Division Signeral, Restorative, Division
and Neurological Devices

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510(k) Number.