(89 days)
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.
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.
This document is a 510(k) summary for the ARC Surgical Biotrak™ Screw System. It describes a medical device, specifically a resorbable compression screw for bone fixation. The provided text is a regulatory submission to the FDA, asserting substantial equivalence to previously marketed devices.
Based on the provided text, there is no information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.
Here's why and what information is available:
- Type of Submission: This is a 510(k) Pre-market Notification. For this type of submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove performance against specific acceptance criteria in the way a clinical study for a new technology might.
- Performance Data Mention: The document explicitly states: "Performance data is included in Section 10. A discussion of clinical and non-clinical tests is not applicable." This means the details of any performance data are in a separate, unprovided section of the 510(k) submission, and the current document does not include a discussion of studies with acceptance criteria, sample sizes, or expert ground truth.
- Focus on Substantial Equivalence: The document repeatedly emphasizes that the device's safety and effectiveness are based on "similarities" and "substantial equivalence" to predicate devices. This approach relies on the existing track record of the predicate devices rather than new performance studies with specific statistical targets.
Therefore, I cannot provide the requested information. The document focuses on:
- Device Description: What the device is made of (PLLA, injection molded), its dimensions, and how it works (headless screw, variable pitch threads).
- Intended Use: Specific types of bone fractures and fusions in upper and lower extremities for which the screw is intended.
- Technological Characteristics: The materials and manufacturing process (PLLA pellets, ring-opening polymerization, stannous octoate catalyst).
- Predicate Devices: A list of existing devices to which the Biotrak™ system is compared for substantial equivalence.
Without "Section 10" or further documentation detailing specific performance tests and their results, none of the points (1-9) in your request can be answered.
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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: (503) 645-9300 / fax: (503) 645-9304 / 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: (503) 645-9300 |
| FAX: (503) 645-9304 |
| 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: (503) 645-9300 / fax: (503) 645-9304 / 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 (240) 276-0120. 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 (800) 638-2041 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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.