(84 days)
The Arthrex Mini Bio-Anchor is a bioabsorbable polylactide (PLDLA) screw intended to provide fixation of suture to bone in various surgeries such as foot. ankle, elbow, hand, and wrist. Specifically;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Foot: Hallux Valgus reconstruction
Ankle: Mid-foot reconstruction
The Arthrex Mini Bio-Anchor is manufactured using poly(L-lactide, co-D-L-lactide) or PLDLA. It is a threaded anchor with a suture evelet for inclusion of the Arthrex Fiberwire™or other appropriate suture. The Mini Bio-Anchor is available with a reusable guide for insertion purposes. Prior to driving in the anchor, it is necessary to prepare the bone by using a uniquely sized single-use sterile drill.
This document is a 510(k) summary for the Arthrex Mini Bio-Anchor, a medical device. It's a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study proving acceptance criteria. Therefore, the information requested in the prompt, which pertains to studies demonstrating performance against acceptance criteria, training and test sets, expert involvement, and statistical analyses, is not present in this type of document.
The document provides:
- Device Description: The Arthrex Mini Bio-Anchor is a threaded, bioabsorbable (PLDLA) anchor for suture fixation to bone, available with a reusable guide and requiring a single-use drill for preparation.
- Intended Use/Indications for Use: Fixation of suture to bone in various surgeries (foot, ankle, elbow, hand, wrist), with specific examples like Biceps Tendon Reattachment in the elbow and Hallux Valgus reconstruction in the foot.
- Substantial Equivalence Claim: The device is claimed to be substantially equivalent to predicate devices based on having the same intended use and not raising new safety or effectiveness questions due to its material, which is well-characterized in predicate devices.
Missing Information:
The document does not contain any of the following, which would typically be found in a study report designed to prove a device meets acceptance criteria:
- A table of acceptance criteria and reported device performance: This document does not define specific performance metrics or acceptance criteria for the device (e.g., tensile strength, pull-out force, biodegradation rate targets) nor does it report any test results against such criteria.
- Sample size used for the test set and data provenance: No test sets or data are mentioned.
- Number of experts used to establish ground truth and their qualifications: No experts are mentioned as establishing ground truth for performance testing.
- Adjudication method for the test set: Not applicable as no test sets or adjudicated results are involved.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This is not an AI-assisted diagnostic device, so an MRMC study is irrelevant.
- Standalone performance (algorithm only without human-in-the-loop performance): Not applicable as this is a physical medical implant, not an algorithm or AI.
- Type of ground truth used: No performance testing results are presented, so no ground truth data is discussed.
- Sample size for the training set: Not applicable as this is not a machine learning or AI device.
- How the ground truth for the training set was established: Not applicable.
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OCT 03 2002
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510(k) Summary
| 510(k) Number: | K022234 |
|---|---|
| Company: | Arthrex, Inc. |
| Address: | 2885 S. Horseshoe Dr., Naples, FL 3410 |
| Telephone: | (239) 643-5553 |
| Facsimile: | (239) 430-3494 |
| Contact: | Ann Waterhouse |
| Trade Name: | Arthrex Mini Bio-Anchor |
| Common Name: | Suture Anchor |
| Classification: | Fastener, Fixation, Biodegradable |
| Product Code: | MAI/HWC |
Description:
The Arthrex Mini Bio-Anchor is manufactured using poly(L-lactide, co-D-L-lactide) or PLDLA. It is a threaded anchor with a suture evelet for inclusion of the Arthrex Fiberwire™or other appropriate suture. The Mini Bio-Anchor is available with a reusable guide for insertion purposes. Prior to driving in the anchor, it is necessary to prepare the bone by using a uniquely sized single-use sterile drill.
Indications for Use:
The Arthrex Mini Bio-Anchor is a bioabsorbable polylactide (PLDLA) screw intended to provide fixation of suture to bone in various surgeries such as foot. ankle, elbow, hand, and wrist. Specifically;
| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction |
|---|---|
| Hand/Wrist: | Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction |
| Foot: | Hallux Valgus reconstruction |
| Ankle: | Mid-foot reconstruction |
Substantial Equivalence:
By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The difference between the Arthrex Mini Bio-Anchor and predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the material is well characterized and has been used in predicate device with similar indications. The device, as designed, is as safe and effective as predicate devices.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 03 2002
Ms. Ann Waterhouse Regulatory Affairs Specialist Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104
Re: K022234
Trade/Device Name: Arthrex Mini Bio-Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MAI Dated: June 28, 2002 Received: July 11, 2002
Dear Ms. Waterhouse:
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 mea.: 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. Ann Waterhouse
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
O Mark N Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K O 2 2 2 3 4
Device Name: Arthrex Mini Bio-Anchor
Indications for Use:
The Arthrex Mini Bio-Anchor is a bioabsorbable polylactide (PLDLA) screw intended to provide fixation of suture to bone in surgeries of the foot, ankle, elbow, and hand/wrist. Specifically;
- Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Foot: Hallux Valgus reconstruction
- Mid-foot reconstruction Ankle:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Option Format 3-10-98)
Mark N Milken
Division of General. Restorative and Neurological Devices
510(k) Number ___ K022234
§ 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.