NEXA COMPRESSION SCREW

K060071 · Nexa Orthopedics, Inc. · HWC · Jan 26, 2006 · Orthopedic

Device Facts

• Record ID: K060071
• Device Name: NEXA COMPRESSION SCREW
• Applicant: Nexa Orthopedics, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jan 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nexa Compression Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

Device Story

Nexa Compression Screw is a metallic bone fixation fastener implanted into bones of the foot and hand, or other bones appropriate for device size. Device provides mechanical compression to facilitate bone healing during reconstruction, osteotomy, arthrodesis, joint fusion, or fracture repair. Used by orthopedic surgeons in clinical settings. Device functions as a mechanical implant; no electronic or software components. Benefits include stabilization of bone segments to promote fusion or healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: 316L Stainless Steel per ASTM F138. Form factor: Screws provided in three diameters of various lengths. Function: Mechanical bone fixation/compression. No software, electronics, or energy sources.

Indications for Use

Indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation in patients requiring metallic bone fixation fasteners in bones appropriate for the device size.

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

• Wright Medical Charlotte High-Demand Compression Screw (K043281)
• Wright Medical Charlotte Multi-Use Compression Screw (K043102)
• KMI Kompressor Compression Screw System (K040356)

Submission Summary (Full Text)

{0}------------------------------------------------

K060076

## 510 (k) SUMMARY

JAN 2 6 2006

The following information summarizes the safety and effectiveness information upon which the substantial equivalence determination for the Nexa Compression Screw is based.

| Prepared: | January 6, 2006 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Applicant: | Nexa Orthopedics, Inc., (dba Futura Biomedical, LLC)<br>10675 Sorrento Valley Road, Suite 100<br>San Diego, CA 92121 |
| Telephone:<br>Fax:<br>Contact: | 858-866-0660<br>858-866-0661<br>Louise M. Focht |

| Device Name: | Nexa Compression Screw |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Nexa Compression Screw |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number | 888.3040 |
| Product Code: | 87 HWC |
| Predicate Devices: | K043281, Wright Medical Charlotte High-Demand<br>Compression Screw; K043102, Wright Medical Charlotte<br>Multi-Use Compression Screw; and<br>K040356 KMI Kompressor Compression Screw System |
| Registration Number: | 2030833 |
| Owner Operator Number: | 9028319 |

## Device Description

The Nexa Compression Screw is made of 316L Stainless Steel, per ASTM F138, and is intended to be implanted into the bones of the foot and hand, and bones appropriate for the size of the device. The screws are provided in three diameters of various lengths. No new materials are used in the development of this implant.

## Indications for Use

The Nexa Compression Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an emblem with three stylized shapes resembling human profiles or abstract forms, arranged vertically. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 6 2006

Ms. Louisa M. Focht Nexa Orthopedics, Inc. 10675 Sorrento Valley Road, Suite 100 San Diego, California 92121

Re: K060071

Trade/Device Name: Nexa Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: January 6, 2006 Received: January 9, 2006

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.

{2}------------------------------------------------

Page 2 - Ms. 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 locally 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" (21 CFR 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/industry/support/index.html.

Sincerely yours,

2
Mark N. Melkerson,

Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 Division -

·

:

:

:

:

{4}------------------------------------------------

## INDICATIONS FOR USE

510 (k) Number (If Known): Device Name: Nexa Compression Screw

Indications for Use

The Nexa Compression Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

Prescription Use Over-The-Counter Use X 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)

2

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : SAVESED SE Cares of and Neurological Lever

**510(k) Number:** K060071