ARTHREX TENODESIS FAMILY

K051726 · Arthrex, Inc. · HWC · Sep 27, 2005 · Orthopedic

Device Facts

• Record ID: K051726
• Device Name: ARTHREX TENODESIS FAMILY
• Applicant: Arthrex, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Sep 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Tenodesis Family of screws, made of various metals and polymers which are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. Specifically: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist

Device Story

Arthrex Tenodesis Screw Family consists of threaded, fully cannulated anchors with rounded heads; manufactured from various polymers or titanium metal. Used for soft tissue reattachment; fixation of ligament and tendon graft tissue. Surgical application in shoulder, elbow, foot/ankle, knee, and hand/wrist. Implantation performed by surgeons using specific instrumentation provided with the device. Device functions as a mechanical fastener to secure soft tissue to bone. Benefits include stable fixation of grafts and tissues during healing process. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material characterization, and comparison to predicate devices.

Technological Characteristics

Threaded, fully cannulated anchors with rounded heads. Materials: various polymers and titanium metal. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for soft tissue reattachment and fixation of ligament and tendon graft tissue in shoulder, elbow, foot/ankle, knee, and hand/wrist surgeries. Applicable to patients requiring reconstruction or repair of ligaments and tendons in these anatomical regions.

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.

Submission Summary (Full Text)

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K05-1726 pg192

SEP 2 7 2005

## 510(k) Summary

| 510(k) Number: | | Arthrex, Inc. |
|-----------------|--|---------------------------------------------|
| Company: | | |
| Address: | | 1370 Creekside Blvd., Naples, FL 34108-1945 |
| Telephone: | | [phone] |
| Facsimile: | | [phone] |
| Contact: | | Ann Waterhouse |
| Trade Name: | | Arthrex Tenodesis Screw Family |
| Common Name: | | Suture Anchor |
| Classification: | | Fastener, Fixation |
| Product Code: | | HWC, MAI, MBI |

## Description:

The Arthrex Tenodesis Family of screws are manufactured using a variety of polymers or titanium metal. They are threaded, fully cannulated anchors with a rounded head. The Tenodesis Screws are available with specific instrumentation to aide implantation.

## Indications for Use:

The Arthrex Tenodesis Family of screws, made of various metals and polymers which are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. Specifically:

- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
- Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
- Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction

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page 242

- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist
By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The difference between the Arthrex Bio-Tenodesis Screw, Arthrex Titanium Tenodesis Screws and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The devices, as designed, are as safe and effective as predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a sans-serif font. The text is arranged around the circle, with "DEPARTMENT OF HEALTH AND HUMAN SERVICES" at the bottom and "USA" at the top.

SEP 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051726

Trade/Device Name: Arthrex Tenodesis Family Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MAI, MBI Dated: September 15, 2005 Received: September 19, 2005

Dear Ms. Waterhouse:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) premated is substantially equivalent (for the indications
referenced above and have determined the device is subsets marketed in intersta referenced above and have decemblicate devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Device Amendments for use stated in the enclosure) to regally manated provice Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug commerce prior to May 28, 1970, the chactinent and other of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval provinces of the Act . The and Cosmetic Act (Act) that do not require upproval controls provisions of the Act. The Act. The Act. The You may, merelore, market the device, sayed to use include registration, listing of
general controls provisions of the Act include requirements michscanding and general controls provisions of the Frec merator required in the manage inst 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 (see above) mo existing major regulations affecting your device can
may be subject to such additional controls. Tixis A. R. A. A. addition FDA may be subject to such additional controlis: Extrems, be found in the Code of Peacharts concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substance or substition of the Act
that FDA has made a determination that your device complies with onemaiss. You must that FDA has made a delemination that your ac-ries by other Federal agencies. You must or any Federal statutes and regulations administers or registration and listing (21 l
comply with all the Act's requirements, including, but not his requirements as set comply with an the Act s requirements, more and manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing and if caplicable, th CFR Part 807); labeling (21 CFR 1 at 601); good market 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050 form in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1

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Page 2- Ms. Ann Waterhouse, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manet.ing of substantial equivalence of your device to a legally prematicate 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 If you desire spochie advision at [phone]. Also, please note the regulation entitled, Connect the Office of Compination" (21CFR Part 807.97). You may obtain. Nusofanding of Terefores to presessibilities 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/cdrl/industry/support/index.html

Sincerely yours,
Mark A. Milikan

Mark Melkerson 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):

Device Name: Arthrex Tenodesis Family

## Indications for Use:

Indications Tor USC.
The Arthrex Tenodesis Screws are constructed of various polymers and metals The Antirex Tenodols Ooft tissue reatachment, i.e. fixation of lighthis and and intended to provide ook toous foomlooder, elbow, knee, footlankle, and hand/wrist. Specifically;

- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Kotator Out Ropaire, Bavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Eatchar Otablization, Midfoot Reconstruction, Metatarsal Hallax Valgair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
- Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Antonol - Graciato - Graciato - Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
- Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Radial Collateral Ligament Reconstruction, Reconstruction, (coonstracarpal joint arthroplasty (basal thumb joint arthroplasty), Carpornotations Reconstructions and repairs, tendon transfer in the hand/ wrist

(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)

Subpart C)

Concurrence of CDRH, Office of Device Evalyation (ODE)

Mark Millican

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

**510(k) Number** K051726

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