FRS SCREW

K062352 · DePuy Orthopaedics, Inc. · HWC · Oct 19, 2006 · Orthopedic

Device Facts

• Record ID: K062352
• Device Name: FRS SCREW
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Oct 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy FRS-Screw is intended to be implanted for the fixation of bone fractures, fusion of a joint or bone reconstructions.

Device Story

The FRS-Screw is a cannulated, thread-head bone fixation screw. It is manufactured from titanium alloy and available in lengths ranging from 10mm to 34mm. The device is intended for surgical use by orthopedic surgeons to provide internal fixation for bone fractures, joint fusions, or osteotomies in the hand and foot. By providing mechanical stability to the bone or joint, the screw facilitates healing and reconstruction. It is a passive implantable device and does not involve electronic processing, software, or external operation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cannulated, thread-head bone fixation screw; material: titanium alloy; lengths: 10-34mm in 2mm increments; classification: Class II, 21 CFR 888.3040, product code HWC.

Indications for Use

Indicated for fixation of bone fractures, joint fusion, or bone reconstruction (osteotomy) of mid-foot bones, metatarsals, phalanges of the foot, or phalanges, metacarpals, and carpals of the hand. Examples include Hallux Valgus correction, Akin Osteotomies, MTP arthrodesis, and Interphalangeal arthrodesis.

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

• DePuy SCARF THREAD-HEAD™ SCREW (K962236)
• NewDeal SA BOLD® Screw (K011262)

Submission Summary (Full Text)

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Kα62352

### 510(k) Summary

(As required by 21 CFR 807.92 and 21 CFR 807.93) OCT 1 9 2006

| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46582<br>Establishment Registration Number: 1818910 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Rebecca Lennard<br>Regulatory Affairs Associate II<br>Telephone: [phone]<br>Facsimile: [phone]<br>Electronic Mail: [e-mail] |
| DATE PREPARED: | May 24, 2006 |
| PROPRIETARY NAME: | FRS® Screw |
| COMMON NAME: | Bone Fixation Screw |
| CLASSIFICATION: | Class II device per 21 CFR 888.3040: Smooth or threaded bone fixation fastener |
| DEVICE PRODUCT CODE: | 87 HWC |
| SUBSTANTIALLY EQUIVALENT<br>DEVICES: | DePuy SCARF THREAD-HEAD™ SCREW,<br>K962236, cleared on September 20, 1996<br>NewDeal SA BOLD® Screw,<br>K011262, cleared on June 15, 2001 |
| DEVICE DESCRIPTION: | |

#### DEVICE DESCRIPTION:

The DePuy FRS-Screw is a cannulated thread-head screw made of a Titanium alloy and is available in lengths of 10-34mm in 2mm increments.

## INTENDED USE AND INDICATIONS:

#### Intended Use:

The DePuy FRS-Screw is intended to be implanted for the fixation of bone fractures, fusion of a joint or bone reconstructions.

#### Indications for Use:

The FRS®-Screw is indicated for fixation of bone fractures, fusion of a joint, or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals, and carpals of the hand. Examples include:

- . Hallux Valgus correction
- 피 Akin Osteotomies

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- MTP arthrodesis
- E Interphalangeal arthrodesis

# BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy FRS®-Screw devices described in this submission are substantially equivalent to the predicate devices based on similarities in intended use, indications for use, materials and design.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2006

DePuy Orthopaedics, Inc. % Ms. Rebecca Lennard 700 Orthopaedic Drive Warsaw. Indiana 46582

Re: K062352

Trade/Device Name: FRS® Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 10, 2006 Received: August 11, 2006

Dear Ms. Lennard:

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 (OS) 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. Rebecca Lennard

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/industry/support/index.html.

Sincerely vours.

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Mark N. Melkerson 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 Statement

510 (k) Number (if known):

FRS®-Screw Device Name:

#### Indications for Use:

The FRS®-Screw is indicated for fixation of bone fractures, fusion of a joint, or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals, and carpals of the hand. Examples include:

- Hallux Valgus correction 트
- 트 Akin Osteotomies
- 체 MTP arthrodesis
- 1 Interphalangeal arthrodesis

(Please do not write below this line - continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

Over-The-Counter-Use:

OR

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

**510(k) Number** LC(125)

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