ARTHERX CORKSCREW FT II SUTURE ANCHOR

K050358 · Arthrex, Inc. · HWC · Apr 15, 2005 · Orthopedic

Device Facts

• Record ID: K050358
• Device Name: ARTHERX CORKSCREW FT II SUTURE ANCHOR
• Applicant: Arthrex, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Apr 15, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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: Shoulder: 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. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament 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.

Device Story

Arthrex Corkscrew FT II Suture Anchor; 5.5 x 16mm fully threaded nondegradable screw; configured with suture or suture and needles. Used by surgeons for fixation of suture to bone during orthopedic procedures (shoulder, foot/ankle, knee, hand/wrist, elbow) and pelvic floor reconstruction. Device provides mechanical anchor point in bone to secure soft tissue; facilitates tendon/ligament reattachment and stabilization. Clinical benefit: restoration of anatomical structure and function via secure tissue-to-bone fixation.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use similarities to predicate devices.

Technological Characteristics

5.5 x 16mm fully threaded nondegradable metallic bone fixation fastener. Device is a screw-type anchor for soft tissue fixation. No software or electronic components.

Indications for Use

Indicated for fixation of suture to bone in patients requiring soft tissue repair in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis, including female patients with urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

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

• Corkscrew Suture Anchor (K003816)
• Corkscrew Suture Anchor (K971723)

Submission Summary (Full Text)

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K050358

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# 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: [phone] ext. 1179 FAX: [phone]

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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K050358

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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.

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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.

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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 [phone] . 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 [phone] or [phone] 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

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# 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 | |
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Concurrence of CORH, Office Af Device Evaluation (ODE)

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