ARC SURGICAL BIOTRAK SCREW

K061763 · Arc Surgical, LLC · HWC · Sep 19, 2006 · Orthopedic

Device Facts

• Record ID: K061763
• Device Name: ARC SURGICAL BIOTRAK SCREW
• Applicant: Arc Surgical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Sep 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biotrak™ resorbable compression screw is intended to provide fixation and/or reduction of small bone fractures, osteotomies, and arthrodeses, cancellous fragments, and osteochondral fragments in the upper and lower extremities. Specifically, these indications include osteochondral defects (OCDs), patella rim fractures, metatarsal fusions and fractures, metatarsal osteotomies, hallux valgus corrections, humeral condyle fractures, metacarpal fusions and fractures, carpal fusions and fractures, radial head fractures, and distal radius fractures.

Device Story

Biotrak™ Screw System consists of headless, resorbable bone screws; injection molded from poly-L-lactic acid (PLLA). Variable thread pitch provides compression across bone fragments. Used by surgeons for fixation/reduction of small bone fractures, osteotomies, and arthrodeses in upper and lower extremities. Provided sterile. Device facilitates bone healing through stable fixation; material resorbs over time.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Resorbable bone fixation screws; material: poly-L-lactic acid (PLLA) (Boehringer-Ingleheim Resomer 210S); diameter: 4.3mm to 4.8mm; length: 16mm to 24mm; variable thread pitch for compression; sterile; non-metallic.

Indications for Use

Indicated for patients requiring fixation or reduction of small bone fractures, osteotomies, arthrodeses, cancellous fragments, and osteochondral fragments in upper and lower extremities, including OCDs, patella rim fractures, metatarsal/metacarpal/carpal fractures and fusions, metatarsal osteotomies, hallux valgus corrections, humeral condyle fractures, and radial head/distal radius fractures.

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

• Arthrex Bio-Compression Screw (K032098)
• Bionx Smart Screw (K003077)
• Biomet ReUnite Bone Screw (K992301)

Submission Summary (Full Text)

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Kobi763 page 1 of 2

Image /page/0/Picture/1 description: The image shows the logo for ARC Surgical. The logo consists of the letters "ARC" in a bold, sans-serif font, with the word "SURGICAL" in a smaller font below. The "C" in "ARC" is stylized to resemble a target, with a circle and crosshairs. The logo is simple and modern, and the target symbol suggests precision and accuracy.

ARC Surgical, LLC 21300 NW Jacobson Rd, Hillsboro, OR 97124 phone: [phone] / fax: [phone] / web: www.arcsurgical.com

510(k) Summarv

SEP 1 9 2006

This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

| Submitter Information: Arc Surgical LLC |
|--------------------------------------------|
| 21300 NW Jacobson Rd |
| Hillsboro, OR 97124 |
| USA |
| Phone: [phone] |
| FAX: [phone] |
| Contact: Ed Boehmer, Regulatory Supervisor |

| Classification Name: | Smooth or threaded metallic bone fixation fastener |
|----------------------------------------|----------------------------------------------------|
| Common Name: | Screw, Fixation, Bone |
| Proprietary Name: | Arc Surgical Biotrak™ Screw System |
| Proposed Regulatory Class: | Class II, 21 CFR 888.3040 |
| Device Product Code: | HWC |
| Legally Marketed Equivalent Device(s): | Arthrex Bio-Compression Screw K032098 |
| | Bionx Smart Screw K003077 |
| | Biomet ReUnite Bone Screw K992301 |

Device Description: The ARC Surgical Biotrak™ Screw System is composed of screws injection molded from poly-L-lactic acid (PLLA) with diameter (4.3mm to 4.8mm) and length (16mm to 24mm). Headless screw compression is obtained from the variable pitch of the threads. The screws are provided sterile.

Intended Use: The Biotrak™ resorbable compression screw is intended to provide fixation and/or reduction of small bone fractures, osteotomies, and arthrodeses, cancellous fragments, and osteochondral fragments in the upper and lower extremities. Specifically, these indications include osteochondral defects (OCDs), patella rim fractures, metatarsal fusions and fractures, metatarsal osteotomies, hallux valgus corrections, humeral condyle fractures, metacarpal fusions and fractures, carpal fusions and fractures, radial head fractures, and distal radius fractures.

These are similar to the intended use of predicate devices and do not raise new issues of safety and effectiveness.

Technological Characteristics: The screws are being injection molded from PLLA pellets (Boehringer-Ingleheim Resomer 210S). The PLLA pellets are polymerized from L-lactide monomers through the process of ring-ovening polymerization. Stannous (tin) octoate is utilized as the catalyst. The predicates devices listed use either PLLA or LactoSorb (82% PLLA/18%PGA).

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Image /page/1/Picture/1 description: The image shows a logo for ARC Surgical. The logo consists of the letters "ARC" in a bold, sans-serif font, with the word "SURGICAL" in a smaller font below. To the right of the letters is a graphic that resembles a target or crosshair, with a curved line forming a partial circle around it. The logo is black and white.

ARC Surgical, LLC 21300 NW Jacobson Rd, Hillsboro, OR 97124

phone: [phone] / fax: [phone] / web: www.arcsurgical.com

Performance data is included in Section 10. A discussion of clinical and non-clinical tests is not applicable.

Based upon the similarities of the ARC Surgical biotrak™ Screw System and the predicate devices studied, the safety and effectiveness of the ARC Surgical biotrakem Screw System is substantially equivalent to the predicate devices referenced.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, represented by three curved lines that suggest the head and wings.

SEP 1 9 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arc Surgical LLC % Mr. Ed Boehmer Regulatory Supervisor 21300 NW Jacobson Road Hillsboro, Oregon 97124

Re: K061763

Trade/Device Name: Arc Surgical BIOTRAK™ Screw System 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 14, 2006

Dear Mr. Boehmer:

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. Ed Boehmer

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" (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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buechner

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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K061763 510(k) Number (if known):

Arc Surgical biotrak™ Screw System Device Name:

Indications For Use:

The Biotrak™ resorbable compression screw is intended to provide fixation and/or reduction of small bone fractures, osteotomies, and arthrodeses, cancellous fragments, reduction of ornall bone nacts in the upper and lower extremities. Specifically, these indications include osteochondral defects (OCDs), patella rim fractures, tarsal fractures, metatarsal fusions and fractures, metatarsal osteotomies, hallux valgus corrections, meral condyle fractures, metacarpal fusions and fractures, carpal fusions and fractures, radial head fractures, and distal radius fractures.

Prescription Use _X_ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use / (Part 21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Soubare BuelnD

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

510(k) Number K061763