(90 days)
Not Found
Not Found
No
The description focuses on the material and mechanical design of a surgical screw for fixation, with no mention of AI or ML capabilities.
Yes.
The device is used for fixation of suture to bone in various repairs and reconstructions across multiple anatomical sites, which directly addresses medical conditions and supports healing or improved function.
No
The device is a screw intended for fixation of suture to bone during surgical repairs and reconstructions, not for diagnosing medical conditions.
No
The device description clearly states it is a physical screw manufactured from poly(L-lactide) and includes a reusable driver for insertion, indicating it is a hardware device, not software.
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 testing is done outside of the body (in vitro).
- Device Description: The Arthrex Bio-Tenodesis Screw is a physical implant made of poly(L-lactide) intended for surgical fixation of suture to bone within the body.
- Intended Use: The intended use clearly describes surgical procedures performed on the body to repair ligaments and tendons.
The device is a surgical implant, not a diagnostic tool used for testing biological samples.
N/A
Intended Use / Indications for Use
The Arthrex Bio-Tenodesis Screw is intended for fixation of suture to bone. This product is intended for the following indications:
- Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
- Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis
- Hand/Wrist: Scapholunate Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial Collateral Ligament Reconstruction
Product codes
MAI, HWC
Device Description
The Arthrex Bio-Tenodesis Screw is manufactured using poly(L-lactide). It is a hex molded down the length of the device. The anchor has a hex head, which is seated on a reusable driver for insertion purposes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Hand/Wrist, Elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
- Please amend your 510(k) summary to include a full statement of 4. intended use.
510(k) Summary
| 510(k) Number: | K010525 |
|---|---|
| Company: | Arthrex, Inc. |
| Address: | 2885 South Horseshoe Drive, Naples, FL 34104 |
| Telephone: | (941) 643-5553 |
| Facsimile: | (941) 435-7191 |
| Contact: | Vernon C. Brown, Manager of Regulatory Affairs |
| Trade Name: | Arthrex Bio-Tenodesis Screw |
| Common Name: | Suture Anchor, Tissue Fixation |
| Classification: | Fastener, Fixation, Biodegradable, Soft Tissue |
| Product Code: | MAI |
Description:
The Arthrex Bio-Tenodesis Screw is manufactured using poly(L-lactide). It is a The Antifex Dio renodocio Coron. hex molded down the length of the device. theraces "doolgh with a the device and up the shaft of the driver. The anchor has a hex head, which is seated on a reusable driver for insertion purposes. has a next nead, which is ocated to prepare the bone using a drill of the appropriate size.
Indications for Use:
The Arthrex Bio-Tenodesis Screw is intended for fixation of suture to bone. This product is intended for the following indications:
- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
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- Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial Collateral Ligament 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 differences between the Arthrex Bio-Tenodesis Screw and the predicate devices cited do not raise any questions regarding safety and effectiveness. Furthermore, the material is well characterized and has been used in predicate The device, as designed, is as safe and devices with similar indications. effective as the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or progress.
Public Health Service
MAY 2 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Vernon C. Brown Manager of Regulatory Affairs Arthrex, Inc. 2885 South Horseshoe Drive Naples. Florida 34104
Re: K010525
Trade Name: Bio-Tenodesis Screw Regulation Number: 888.3040 Regulatory Class: II Product Code: HWC and MAI Dated: February 22, 2001 Received: February 22, 2001
Dear Mr. Brown:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
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Page 2 - Mr. Vernon C. Brown
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Mark A Mckinan
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): K010525
Device Name: Arthrex Bio-Tenodesis Screw
Indications for Use:
The Arthrex Bio-Tenodesis Screw is intended for fixation of suture to bone. This product is intended for the following indications:
- Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair. Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
- Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis
- Hand/Wrist: Scapholunate Reconstruction, Collateral Ligament Ulnar Reconstruction, Ligament Radial Collateral Ligament Reconstruction
- Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial Collateral Ligament Reconstruction
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
. Mark N. Milburn
Division Sign-Off) Division of General, Restorative 8 10 Nourological Devices
(Option Format 3-10-98)
510(k) Number _ K010525