(84 days)
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No
The summary describes a purely mechanical, bioabsorbable screw for suture fixation and makes no mention of AI or ML technology.
No
The device provides mechanical fixation for suture to bone; it does not treat or cure a disease or condition, which is characteristic of a therapeutic device.
No
The device is described as a bioabsorbable screw intended for fixation of suture to bone in various reconstructive surgeries, not for diagnosing conditions.
No
The device description clearly states it is a physical, bioabsorbable screw made of PLDLA, intended for surgical fixation of suture to bone. It also mentions a reusable guide and a single-use drill, all of which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Arthrex Mini Bio-Anchor is a surgical implant used to fix suture to bone during various surgical procedures. It is a physical device inserted into the body.
- Intended Use: The intended use is to provide mechanical fixation of suture to bone, not to analyze biological samples for diagnostic purposes.
The description clearly indicates a device used in vivo (within the living body) for surgical repair, which is the opposite of in vitro (in glass/outside the body) diagnostics.
N/A
Intended Use / 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 Collagteral Ligament Reconstruction
Foot: Hallux Valgus reconstruction
Ankle: Mid-foot reconstruction
Product codes (comma separated list FDA assigned to the subject device)
MAI, HWC
Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Foot, ankle, elbow, hand, and wrist.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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