(11 days)
K003227, K99097
No
The device description and intended use are for a physical suture anchor, and there is no mention of AI or ML in the provided text.
No
The device is a medical implant (suture anchor) used for fixation of sutures in various orthopedic and pelvic procedures, not primarily for therapeutic treatment itself but rather as a surgical aid to repair tissue.
No
The device is a suture anchor intended for fixation of suture in various orthopedic repair procedures, not for diagnosing medical conditions.
No
The device description clearly states it is a "5.5 x 15mm fully threading anchor configured with suture or with suture and needles," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's function in surgical procedures to fix suture in various anatomical locations. This is a direct surgical intervention on the patient's body.
- Device Description: The description details a physical implantable device (suture anchor) used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used for diagnostic purposes by analyzing samples outside the body. This device is a surgical implant used inside the body for mechanical fixation.
N/A
Intended Use / Indications for Use
The Arthrex Bio-Corkscrew FT Suture Anchor is intended for fixation of suture in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures:
Shoulder: Rotator Cuff Repair, 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 Recons-truction, Metatarsal Ligament Repair, Lateral Collateral Ligament Repair.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis, Posterior Cruciate Ligament Repair, and Ligamentous Repair.
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.
Product codes
HWC, MAI
Device Description
The Arthrex Bio-Corkscrew Suture Anchor is a 5.5 x 15mm fully threading The Althrox Blo Gonfigured 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, and pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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
DEC 1 4 2004
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS IX.
ARTHREX BIO-CORKSCREW SUTURE ANCHOR
MANUFACTURER / SPONSOR
Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945
Sally Foust, RAC 510(K) CONTACT: Sr. Regulatory Affairs Specialist Telephone: (239) 643-5553 ext. 1251 FAX: (239) 598-5539
TRADE NAME:
COMMON NAME: PRODUCT CODE / CLASSIFICATION NAME Bio-Corkscrew Suture Anchor
Fastener; Screw, Fixation, Bone; Suture
MAI Fastener, Fixation, Biodegradable, Soft Tissue
21 CFR 888.3040 / HWC Fastener, Fixation, Nondegradable, Soft Tissue Smooth or threaded metallic bone fixation fastener
21 CFR 888.5000 Suture, Nonabsorbable Synthetic Polyethylene
PREDICATE DEVICE:
Bio-Corkscrew Suture Anchor: K003227 & K990987
DEVICE DESCRIPTION AND INTENDED USE:
DEVICE DESCRIP TION AND INTENDED GOL:
The Arthrex Bio-Corkscrew Suture Anchor is a 5.5 x 15mm fully threading The Althrox Blo Gonfigured with suture or with suture and needles.
The Arthrex Bio-Corkscrew Suture Anchor is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis.
SUBSTANTIAL EQUIVALENCE SUMMARY
SUBSTANTIAL EQUIVALENGE OOMMAx : :
The Arthrex Bio-Corkscrew Suture Anchor is substantially equivalent to the same - Any The Antifies Dio-Oorksolow Guture Anohor in the basic features and intended uses are the same. Any Corkscrew Suture Anonor in which the Backsonew Suture Anchor and the predicate Arthrex Blodifferences between the Arthex Blo Serkoron and do not raise questions concerning safety and Corkscrew Sature Anchor are Scholored miner and be and the producted producted producted producted products dovice ellectivelless: Dased on the midner outmation one interestly marketed predicate device.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2004
Ms. Sally Foust, RAC Sr. Regulatory Affairs Specialist Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108
Re: K043337
Trade/Device Name: Arthrex Bio-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 Dated: December 2, 2004 Received: December 3, 2004
Dear Ms. Foust:
We have reviewed your Section 510(k) premarket notification of intent to market the device in we nave reviewed your Section 310(t) premiented in substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the enclosure) to tegans manative province to the Medical Device American France Free d. Bruss connitieres provision to May 20, 1978, the encordance with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval apploval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applic and Cosment Act (Act) that do not require appro the general controls provisions of the Act. The You may, mercrore, market the device, equirements for annual registration, listing of general controls provisions of arctice, 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 If your device is classified (500 above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controllar entires of Parts 800 to 898. In addition, FDA may be found in the Outsting your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oe advised that 1 Dri- 3 issuation or a cases of the other requirements of the Act that 117A has made a colorimiation administered by other Federal agencies. You must of any reactal statutes and regulations and limited to: registration and listing (21 Comply with an the 7te of requirements, and manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bysteins (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -- Ms. Sally Foust, RAC
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" (21CFR Part 807.97) you may obtain. 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 Malle
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
3
III. INDICATIONS FOR USE FORM
Indications for Use
| 510(k) Number (if known): | K043337 |
|---|---|
| Device Name: | Arthrex Bio-Corkscrew FT Suture Anchor |
| Indications for Use: |
The Arthrex Bio-Corkscrew FT Suture Anchor is intended for fixation of suture in the The Arthrex Bio-Corkscrew FT Suture Anchor is intended for Sublish of Sublished
shoulder, footlankle, knee, hand/wrist, elbow, and pelvis in, but not limited to, the followin procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular
Shoulder: Repair, M. Bearly Consuler Shift or Capsulolabral Reconstru Shoulder: Rotator Cuff Repairs, Bankari Repair, OEA. Editor Repair, Capsulolabral Reconstruction.
Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconst
Start - Allus Lateral Stabilization, Medial Stabilization, Achiles Tendon Repair, Hallux Valgus Reconstruction, Me Pool Affikie. Lateral Oldomballianal Ligament Repair.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament
Production Collection Contacter Chlique Ligament Repair, and lligtib Knee: Anterior Cruciate Ligament Repair, Medial Collateral Elganent Repair, List Collection
Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial
eral Collection, Factor, Liga 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.
Prescription Use
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 PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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