ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR

K043337 · Arthrex, Inc. · HWC · Dec 14, 2004 · Orthopedic

Device Facts

• Record ID: K043337
• Device Name: ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR
• Applicant: Arthrex, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Dec 14, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Bio-Corkscrew FT Suture Anchor is intended for fixation of suture to bone 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 Reconstruction, Subtalar Arthrodesis. Knee: Anterior Cruciate Ligament Repair, 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. 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.

Device Story

Arthrex Bio-Corkscrew FT Suture Anchor is a 5.5 x 15mm fully threaded bone fixation fastener; configured with suture or suture and needles. Used by surgeons in clinical settings for soft tissue-to-bone fixation across multiple anatomical sites (shoulder, knee, foot/ankle, hand/wrist, elbow, pelvis). Device functions as a mechanical anchor to secure sutures to bone, facilitating tissue reattachment or reconstruction. Benefits include stable fixation for orthopedic and pelvic floor repairs.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

5.5 x 15mm fully threaded bone fixation fastener; biodegradable material; mechanical screw-in fixation principle.

Indications for Use

Indicated for fixation of suture to bone in shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis for various soft tissue repair procedures, including rotator cuff, ligament, and tendon repairs, and bladder neck suspension for female urinary incontinence.

Regulatory Classification

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.

Predicate Devices

• Bio-Corkscrew Suture Anchor (K003227)
• Bio-Corkscrew Suture Anchor (K990987)

Submission Summary (Full Text)

{0}------------------------------------------------

K043337

### 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: [phone] ext. 1251 FAX: [phone]

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 [phone]. 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 [phone] or [phone] 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)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1_