(19 days)
The Arthrex Corkscrew FT III Suture Anchor with three #2 sutures is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis.
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Bicens 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
Knee: Medial Collateral Ligament 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
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.
The Arthrex Corkscrew FT III Suture Anchor with three #2 sutures is a 5.5 x 15mm fully threaded (FT) titanium screw that is available configured with suture.
This is a 510(k) summary for a medical device (surgical suture anchor) and does not contain information about software or AI performance, acceptance criteria, or a study meeting those criteria. Therefore, I cannot provide the requested details.
The provided text describes a traditional medical device (Arthrex Corkscrew FT III Suture Anchor with three #2 sutures) and its intended use, along with a statement of substantial equivalence to a predicate device. There is no mention of an algorithm, AI, or any performance study beyond the declaration of substantial equivalence for the physical device.
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K062679 page 41
4 510(k) Summary of Safety and Effectiveness
| Manufacturer/Sponsor | Arthrex, Inc.1370 Creekside Boulevard Naples, Florida 34108-1945 |
|---|---|
| 510(k) Contact | Nancy Hoft |
| Regulatory Affairs Associate | |
| Telephone: 239/643.5553, ext. 1113SEP 27 2006 | |
| Fax: 239/598.5539 | |
| Email: nhoft@arthrex.com | |
| Trade Name | Arthrex Corkscrew FT III Suture Anchor with three #2 sutures |
| Common Name | Fastener; Screw, Fixation, Bone; Suture |
| Product Code - | MBI - fastener, fixation, nondegradable, soft tissue |
| Classification Name | HWC - screw, fixation, bone |
| GAT - suture, nonabsorbable, synthetic, polyethylene | |
| Predicate Device | Corkscrew FT II Suture Anchor, AR-1928SF-2 |
| Device Descriptionand Intended Use | The Arthrex Corkscrew FT III Suture Anchor with three #2 sutures isa 5.5 x 15mm fully threaded (FT) titanium screw that is availableconfigured with suture. |
| The Arthrex Corkscrew FT III Suture Anchor with three #2 suturesis intended for fixation of suture to bone in the shoulder, foot/ankle,knee, hand/wrist, elbow, and pelvis. | |
| SubstantialEquivalence Summary | The Arthrex Corkscrew FT III Suture Anchor with three #2 sutures issubstantially equivalent to the predicate Arthrex Corkscrew FT IISuture Anchor with two #2 sutures in which the basic features andintended uses are the same. Any differences between the ArthrexCorkscrew FT III Suture Anchor with three #2 sutures and thepredicate Arthrex Corkscrew FT III Suture Anchor with two #2sutures are considered minor and do not raise questions concerningsafety and effectiveness. Based on the information submitted,Arthrex, Inc. has determined that the new Corkscrew FT III SutureAnchor with three #2 sutures is substantially equivalent to thecurrently marketed predicate device. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized representation of a human figure, with three abstract shapes forming the body and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 7 2006
Ms. Nancy Hoft Regulatory Affairs Associate Arthrex, Inc 1370 Creekside Boulevard Naples, Florida 34108
Re: K062679
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC. MBI Dated: September 7, 2006 Received: September 8, 2006
Dear Ms. Hoft:
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 -- Ms. Nancy Hoft
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 firmational and Consumer Assistance at its toll-free sumber (800) 638-2041. on 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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Indications for Use
510(k) Number: Device Name:
Arthrex Corkscrew FT III Suture Anchor with Three #2 Sutures
The Titanium Corkscrew 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, Bicens 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
Knee: Medial Collateral Ligament 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
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.
AND/OR Over-The-Counter Use No Prescription Use_ (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 1 of 1
Division Sta
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number L060619
§ 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.