(60 days)
Not Found
No
The 510(k) summary describes a mechanical suture anchor and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The "Intended Use / Indications for Use" section specifies that the device is "intended for fixation of suture to bone" for various repairs and reconstructions, not for diagnosing, curing, mitigating, treating, or preventing disease, which are characteristics of a therapeutic device. It serves as a mechanical anchor, aiding in the repair of injuries.
No
The provided text describes a suture anchor intended for fixation of suture to bone in various anatomical locations. It is a surgical implant used for repair and reconstruction, not for diagnosis.
No
The device description clearly states it is a "fully threaded (FT) nondegradable screw," which is a physical hardware component, 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (a suture anchor) intended for fixation of suture to bone within the body during surgical procedures. It is used in vivo (within a living organism).
The description and intended use are entirely focused on a device used during surgery for structural repair, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Arthrex Corkscrew FT II Suture Anchor is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis. Specifically:
Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: 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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis.
Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Hand/Wrist: Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction.
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
Product codes (comma separated list FDA assigned to the subject device)
HWC, MBI, GAT
Device Description
The Arthrex Corkscrew FT II Suture Anchor is a 5.5 x 16mm fully threaded (FT) nondegradable screw that is available configured with suture or with suture and needles.
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, pelvis
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 (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.
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
Page 1 of 2-
VIII. 510(k) SUMMARY OF SAFETY AND EFFECTIVENES
ARTHREX CORKSCREW SUTURE ANCHOR
| MANUFACTURER / SPONSOR | Arthrex, Inc. |
|---|---|
| 1370 Creekside Boulevard | |
| Naples, Florida 34108-1945 |
510(K) CONTACT:
Ann Waterhouse, RAC Sr. Regulatory Affairs Specialist Telephone: (239) 643-5553 ext. 1179 FAX: (239) 598-5539
TRADE NAME:
Corkscrew FT II Suture Anchor
Fastener; Screw, Fixation, Bone; Suture
COMMON NAME: PRODUCT CODE /
CLASSIFICATION NAME
HWC/ 21 CFR 888.3040
Fastener, Fixation, Nondegradable, Soft Tissue Smooth or threaded metallic bone fixation fastener
GAT/21 CFR 8788.5000
Suture, Nonabsorbable Synthetic Polyethylene
PREDICATE DEVICE:
Corkscrew Suture Anchor: K003816 & K971723
DEVICE DESCRIPTION AND INTENDED USE:
The Arthrex Corkscrew FT II Suture Anchor is a 5.5 x 16mm fully threaded (FT) nondegradable screw that is available configured with suture or with suture and needles. The Arthrex Corkscrew FT II Suture Anchor is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis. Specifically:
Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: 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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis.
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Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Hand/Wrist: Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction.
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
SUBSTANTIAL EQUIVALENCE SUMMARY
The Arthrex Corkscrew FT II Suture Anchor is substantially equivalent to the predicate Arthrex Corkscrew Suture Anchor in which the basic features and intended uses are the same. Any differences between the Arthrex Corkscrew FT II Suture Anchor and the predicate Arthrex Corkscrew Suture Anchor are considered minor and do not raise questions conceming safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the new Corkscrew FT II Suture Anchor is substantially equivalent to the currently marketed predicate device.
2
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 image of an eagle with its wings spread, facing to the right.
Public Health Service
APR 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ann Waterhouse, RAC Senior Regulatory Affairs Specialist Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1845
Re: K050358
Trade/Device Name: Arthrex Corkscrew FT Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MBI, GAT Dated: March 15, 2005 Received: March 17, 2005
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 Erth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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) I mis letter will anow you to ough maning of substantial equivalence of your device to a legally premation redicate device 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 If you desire specific acres at (240) 276-0120 . Also, please note the regulation entitled, Contact the Office of Conner to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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/industry/support/index.html.
Sincerely yours,
Tom Allen
Miriam C. Provost, Ph.D. pr Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): ___Koso358
Device Name: Arthrex Corkscrew FT Suture Anchor
Indications for Use:
The Arthrex Corkscrew FT Suture Anchor 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 Shouldor: - Notator - 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 Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Elbow: Collateral Ligament Reconstruction.
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER | |
|---|---|
| AGE IF NEEDED) And The | |
| The state of the state the may and comments of the commentation of the comments of the comments of the comments of the comments of the comments of the comments of the comment | |
| 서울동문동문제출사무역사무부산부문제출장부르부동문콜로부르부르부동문출장업소동문출장부르부모텔출장마사지샵 |
Concurrence of CORH, Office Af Device Evaluation (ODE)
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Ko5o358