(85 days)
Not Found
Not Found
No
The device description and intended use clearly describe a physical, bioabsorbable screw for surgical fixation, with no mention of software, algorithms, or any AI/ML related terms.
No
The device is a bioabsorbable screw intended for fixation of ligament and tendon graft tissue during surgery to aid in repair, not to treat a disease or condition itself.
No
The device description and intended use clearly state that the Bio-Tenodesis Screw is a bioabsorbable screw intended to provide fixation of ligament and tendon graft tissue in various surgical repairs. It is a surgical implant used for treatment, not for diagnosing conditions.
No
The device description clearly states it is a physical screw made of poly(L-lactide) and includes a reusable driver for insertion, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- Device Description: The Arthrex Bio-Tenodesis Screw is a physical implantable device (a screw) used to fix ligament and tendon tissue within the body during surgery.
- Intended Use: The intended use clearly describes surgical procedures where the screw is implanted to provide mechanical support and fixation.
The information provided describes a surgical implant, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Arthrex Bio-Tenodesis Screw is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, and hand/wrist. Specifically;
- 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
- Elbow. Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Arthrex Bio-Tenodesis Screw is manufactured using poly(L-lactide). It is a threaded anchor which is fully cannulated and has a rounded head. The Bio-Tenodesis Screw is available with a reusable driver for insertion purposes. Prior to driving in the anchor, it is necessary to prepare the bone using a drill of the appropriate size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, elbow, foot/ankle, and hand/wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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
APR 0 2 2002
Ko 20043
510(k) Summary
| 510(k) Number: | |
|---|---|
| Company: | Arthrex, Inc. |
| Address: | 2885 S. Horseshoe Dr., Naples, FL 34104 |
| Telephone: | (941) 643-5553 |
| Facsimile: | (941) 430-3494 |
| Contact: | Ann Waterhouse |
| Trade Name: | Arthrex Bio-Tenodesis Screw |
| Common Name: | Suture Anchor |
| Classification: | Fastener, Fixation, Biodegradable, Soft Tissue |
MAI
Description:
Product Code:
The Arthrex Bio-Tenodesis Screw is manufactured using poly(L-lactide). It is a threaded anchor which is fully cannulated and has a rounded head. The Bio-Tenodesis Screw is available with a reusable driver for insertion purposes. Prior to driving in the anchor, it is necessary to prepare the bone using a drill of the appropriate size.
Indications for Use:
The Arthrex Bio-Tenodesis Screw is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, and hand/wrist. Specifically;
- Shoulder. Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps 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
- Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow. Radial Collateral Ligament Reconstruction
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
1
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 domonotrouled to be be a vice Tenodesis Screw and the 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.
0000006
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 2 2002
Ms. Ann Waterhouse Regulatory Affairs Specialist Arthrex Inc. 2885 South Horseshoe Drive Naples, Florida 34104
Re: K020043
Trade/Device Name: Arthrex Bio-Tenodesis Screws, 4.0 mm and 5.5 mm Models Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: January 4, 2002 Received: January 7, 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 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.
3
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" (21CFR 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,
Mark N Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
KOLOOFS 510(k) Number (if known):
Device Name:
Asthrex B.b - Tenodes . S
Indications for Use:
The Arthrex Bio-Tenodesis Screw is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, and hand/wrist. Specifically;
- 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
- Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial Collateral Ligament Reconstruction
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, 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. Millerson
(Option Format 3-10-98)
vision Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number K020043