NEXFIX COMPRESSION STAPLE

K070688 · Nexa Orthopedics, Inc. · JDR · May 18, 2007 · Orthopedic

Device Facts

• Record ID: K070688
• Device Name: NEXFIX COMPRESSION STAPLE
• Applicant: Nexa Orthopedics, Inc.
• Product Code: JDR · Orthopedic
• Decision Date: May 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NexFix™ Compression Staple is indicated for fixation of fracture, fusion, and osteotomies of the hand, fore foot, mid foot and hind foot.

Device Story

NexFix™ Compression Staple is a stainless steel orthopedic implant; designed for bone fixation, fusion, and osteotomy procedures in the hand and foot. Device provided in 21 sizes; implanted by surgeons to provide mechanical stability to bone segments. Operates as a passive fixation device; maintains compression across fracture or fusion sites to facilitate healing. No electronic, software, or algorithmic components. Clinical benefit derived from stabilization of bone segments during the healing process.

Clinical Evidence

No clinical data provided as a basis for substantial equivalence; bench testing only.

Technological Characteristics

Stainless steel bone fixation staple; 21 available sizes; passive mechanical fixation; non-electronic; non-software.

Indications for Use

Indicated for fixation of fractures, fusions, and osteotomies of the hand, forefoot, midfoot, and hindfoot.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Wright Medical Compression Staple and simple staple (K043059)
• New Deal UniClip Staple (K011716)
• Intelifuse Warmsystem with StimuLinks (K060014)

Submission Summary (Full Text)

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510 (k) Summary

| Prepared: | March 8, 2007 |
|------------------------|----------------------------------------------------------------------------------------------------|
| Applicant: | Nexa Orthopedics, Inc.<br>11035 Roselle Street<br>San Diego, CA 92121 |
| Contact: | Louise M. Focht |
| Device Name: | Nexa Staple |
| Device Trade Name: | NexFix™ Compression Staple |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number | 21 CFR 888.3030 Single/multiple<br>component metallic bone fixation<br>appliances and accessories. |
| Product Code: | 87 JDR |
| Registration Number: | 2030833 |
| Owner Operator Number: | 9028319 |

R070688

MAY 18 2007

### Legally marketed device to which substantial equivalence is claimed:

The legally marketed devices to which substantial equivalence is claimed are the K043059 Wright Medical Compression Staple and simple staple, K011716 New Deal UniClip Staple, and K060014 Intelifuse Warmsystem with StimuLinks

### Device Description:

The Nexa Orthopedics NexFix™ Compression Staple is made of Stainless Steel intended to be implanted into the bones of the fore foot, mid foot and hind foot. The stables are provided in 21 sizes. The staples are used for fracture fixation, fusion, and osteotomy of the bones of the hand and foot.

#### Intended Use:

The Nexa Staple is indicated for fixation of fracture, fusion, and osteotomies of the hand, fore foot, mid foot and hind foot.

## Summary of Technologies:

The device and the predicate devices have similar design characteristics and intended use. Information provided in the application demonstrates the Nexa device is substantially equivalent to the predicate device.

Non-Clinical Testing: Non-Clinical laboratory testing was performed to determine substantial equivalence. The results indicate that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nexa Orthopedics, Inc % Ms. Louise M. Focht 11035 Roselle St. San Diego, California 92121

MAY 1 8 2007

Re: K070688

Trade/Device Name: NexFix™ Compression Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR Dated: March 8, 2007 Received: March 13, 2007

Dear Ms. Focht:

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 - Ms. 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), please contact the Office 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 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 vours.

Karvare bouchn

Mark N. Melkerson 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): Ko7068
Device Name: NexFix™ Compression Staple

# Indications for Use:

The NexFix™ Compression Staple is indicated for fixation of fracture, fusion, and osteotomies of the hand, fore foot, mid foot and hind foot.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Seubere Brient

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

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**510(k) Number** k670688