ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY

K061863 · Arthrex, Inc. · HWC · Oct 19, 2006 · Orthopedic

Device Facts

• Record ID: K061863
• Device Name: ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY
• Applicant: Arthrex, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Oct 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Corkscrew Family of Suture Anchors has been previously cleared in 510(k) K003817, K003227, K043337, and K050358. These suture anchors are intended for fixation of suture(soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures: Shoulder: Rotator Cuff Repairs, 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, Metatarsal Ligament /Tendon Repair, Bunionectomy . . 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. Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Elbow: Collateral Ligament Reconstruction, Lateral Epicondylitis repair. Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency. Hip: Capsular repair, acetabular labral repair. The Arthrex PushLock™, previously cleared under 510(k) K051219, is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, hip, and pelvis in the following procedures: Rotator Cuff Repair, 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial 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, Lateral Epicondylitis repair. Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency. Hip: Capsular repair, acetabular labral repair. The Arthrex Tak™ Family, previously cleared under 510(k)s K971723, K000506, and K050749, is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow, shoulder, and in select maxillofacial applications. Specific indications are listed below and are size appropriate per patient needs: Skull: Stabilization and fixation of oral cranio-maxillofacial skeletal bone. mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction. soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis Bladder Neck Suspension for female urinary incontinence due to Pelvis: urethral hypermobility or intrinsic sphincter deficiency. Hip: Capsular repair, acetabular labral repair.

Device Story

Arthrex Corkscrew, PushLock, and Tak families are suture anchors for soft tissue-to-bone fixation; used in orthopedic procedures (shoulder, knee, hip, etc.) and maxillofacial applications. Implants consist of titanium alloy, PLLA, PLDLA, or PEEK; offered in various shapes/sizes; provided sterile. Operated by surgeons in clinical/OR settings to secure sutures to bone, facilitating tissue repair and healing. Device functions as mechanical fixation hardware; no electronic or software components.

Clinical Evidence

bench testing only

Technological Characteristics

Materials: Titanium alloy, PLLA, PLDLA, PEEK. Mechanical fixation via suture anchors. Sterile, single-use. No software, electronics, or connectivity.

Indications for Use

Indicated for suture or soft tissue fixation to bone in shoulder, foot/ankle, knee, hand/wrist, elbow, pelvis, and maxillofacial regions. Patient population includes adults requiring orthopedic reconstruction or stabilization, and females 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

• Smith & Nephew BioRaptor 2.9 mm (K053344)
• Smith & Nephew TwinFix Ti 2.8 & 3.5 mm (K053344)

Reference Devices

• Arthrex Corkscrew Family (K003817, K003227, K043337, K050358)
• Arthrex PushLock (K051219)
• Arthrex Tak Family (K971723, K000506, K050749)

Submission Summary (Full Text)

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K 061863 page 141

# 510(k) Summary

OCT 1 9 2006

| 510(k) Number: | |
|-----------------|------------------------------------------------------|
| Company: | Arthrex, Inc. |
| Address: | 1370 Creekside Blvd., Naples, FL 34108-1945 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Contact: | Ann Waterhouse, RAC |
| Device Name: | Arthrex PushLock, Tak, and Corkscrew products |
| Classification: | Screw, Fixation, Bone, degradable and non-degradable |
| Product Code: | HWC (21 CFR 888.3040) |
| | MBI (21 CFR 888.3040) |
| | MAI (21 CFR 888.3030) |

## Description:

The Arthrex Families which are part of this expanded indications submission are as follows: Arthrex Bio-Corkscrew and Corkscrew Arthrex Bio-Corkscrew FT and Corkscrew FT Arthrex PushLock Arthrex Tak Family

These implants are comprised of titanium alloy, poly (L-lactide) or PLLA, poly (Llactide-Co-D, L-lactide) or PLDLA, and Polyaryletherketone or (PEEK). They are offered in several different shapes and sizes. They are offered sterile.

## Predicate Devices;

The indication of hip labral repair is substantially equivalent to K053344, Smith & Nephew BioRaptor 2.9 mm and TwinFix Ti 2.8 & 3.5 mm implants.

## Indications for Use:

Please see individual indications for use statements, additional indications include Capsular repair and Acetabular labral repair.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2006

Arthrex, Inc. % Ann Waterhouse, RAC Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108

Re: K061863

Trade/Device Name: Arthrex Corkscrew, Corkscrew FT, Bio-Corkscrew, and Bio Corkscrew FT Suture Anchor(s) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, JDR, MAI Dated: September 6, 2006 Received: September 7, 2006

Dear Ms. Waterhouse:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrobars) to regists the Medical Device Amendments, or to eonimores that have been reclassified in accordance with the provisions of the Federal Food, Drug, do noos that have been that do not require approval of a premarket approval application (PMA). and Cosmeter For (110) that be nevice, subject to the general controls provisions of the Act. The r ou may) arones provisions of the Act include requirements for annual registration, listing of general controls provision 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 anv Federal statutes and regulations administered by other Federal agencies. You must or any i with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 301); good manufacturing practice requirements as set Orth 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 - Ann Waterhouse, 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" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or 240-276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

R.A. Riffon

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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## 510(k) Number (if known):

## Device Name: Arthrex Corkscrew, Corkscrew FT, Bio-Corkscrew, and Bio-Corkscrew FT Suture Anchor(s)

## Indications for Use:

The Arthrex Corkscrew Family of Suture Anchors has been previously cleared in 510(k) K003817, K003227, K043337, and K050358. These suture anchors are intended for fixation of suture(soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures:

Shoulder: Rotator Cuff Repairs, 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, Metatarsal Ligament /Tendon Repair, Bunionectomy . .
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.

Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Elbow: Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

Hip: Capsular repair, acetabular labral repair.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Prescription Use | X |
|-----------------------------|----|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | No |
| (21 CFR 807 Subpart C) | |

Concurrence of CDRH, Office of Device Evaluation (ODE)

page 1 of ____________________________________________________________________________________________________________________________________________________________________

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## 510(k) Number (if known):

#### Device Name: Arthrex PushLock™

#### Indications for Use:

The Arthrex PushLock™, previously cleared under 510(k) K051219, is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, hip, and pelvis in the following procedures:

Rotator Cuff Repair, 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial 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, Lateral Epicondylitis repair.

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

Hip: Capsular repair, acetabular labral repair.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

3 page 2 of

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K061663

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## 510(k) Number (if known):

### Device Name: Arthrex Tak Family

Indications for Use: The Arthrex Tak™ Family, previously cleared under 510(k)s K971723, K000506, and K050749, is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow, shoulder, and in select maxillofacial applications. Specific indications are listed below and are size appropriate per patient needs:

Skull: Stabilization and fixation of oral cranio-maxillofacial skeletal bone. mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction. soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull

Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

Bladder Neck Suspension for female urinary incontinence due to Pelvis: urethral hypermobility or intrinsic sphincter deficiency.

Hip: Capsular repair, acetabular labral repair.

(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use x AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)