TI - SCREW ANCHOR SP

K042460 · Arthrotek, Inc. · MBI · Oct 29, 2004 · Orthopedic

Device Facts

• Record ID: K042460
• Device Name: TI - SCREW ANCHOR SP
• Applicant: Arthrotek, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Oct 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ti-Screw Anchor SP is indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows: Shoulder Indications - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand Indications - Ulnar/radial collateral ligament reconstruction. Ankle/Foot Indications - Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction. Elbow Indications - Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction. Knee Indications - Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.

Device Story

Ti-Screw Anchor SP is a metallic bone fixation fastener; consists of screw tip, screw body, and internal cross pin for suture attachment. Used by surgeons in orthopedic soft tissue reattachment procedures (shoulder, wrist/hand, ankle/foot, elbow, knee). Screw tip engages bone; body drives anchor into site; pin secures suture. Device provides mechanical fixation of soft tissue to bone to facilitate healing. Used in clinical/OR settings.

Clinical Evidence

No clinical testing provided; substantial equivalence based on bench testing.

Technological Characteristics

Titanium alloy screw anchor; includes screw tip, body, and internal cross pin. Mechanical fixation device; non-degradable. Class II device per 21 CFR 888.3040.

Indications for Use

Indicated for soft tissue reattachment in shoulder, wrist/hand, ankle/foot, elbow, and knee procedures, including ligament, tendon, and capsule repairs/reconstructions.

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

• Metal Screw Anchor (K012503)
• Harpoon and Mini Harpoon Suture Anchors (K973775)

Submission Summary (Full Text)

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OCT 2 9 2004

## K042460

## 510(k) Summary

| Applicant/Sponsor: | Arthrotek Inc.<br>(A wholly owned subsidiary of Biomet, Inc.)<br>56 Bell Drive<br>Warsaw, IN 46582<br>FDA Registration #: 1825034 |
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| Contact Person: | Gary Baker<br>Biomet Manufacturing Corp.<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587<br>Telephone: [phone]<br>Fax: [phone] |
| Proprietary Name: | Ti - Screw Anchor SP |
| Common Name: | Screw Anchor |
| Classification Name: | Fastener, Fixation, Non-degradable, Soft Tissue<br>21 CFR §888.3040 |
| Legally Marketed Devices To Which Substantial Equivalence Is Claimed: | Metal Screw Anchor (K012503) - Biomet Inc.<br>Harpoon and Mini Harpoon Suture Anchors (K973775) - Biomet Inc. |
| Device Description: | The Ti-Screw Anchor SP consists of a screw tip, a screw body, and an<br>internal cross pin to attach the suture. The screw tip engages the bone<br>while the screw body provides the means to drive the anchor in, and the<br>pin is used to attach the suture to the anchor. |
| Intended Use: | Indications For Use: The Ti-Screw Anchor SP is indicated for use in soft<br>tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot,<br>elbow, and knee. Specific indications are as follows: |
| | Shoulder Indications - Bankart repair, SLAP lesion repair, acromio-<br>clavicular separation, rotator cuff repair, capsule repair or capsulolabral<br>reconstruction, biceps tenodesis, deltoid repair. |
| | Wrist/Hand Indications - Ulnar/radial collateral ligament reconstruction. |
| | Ankle/Foot Indications - Lateral stabilization, medial stabilization,<br>Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid-<br>and forefoot reconstruction. |
| | Elbow Indications - Ulnar or radial collateral ligament reconstruction,<br>biceps tendon reconstruction. |
| | Knee Indications - Medial collateral ligament repair, lateral collateral<br>ligament repair, posterior oblique ligament repair, joint capsule closure,<br>iliotibial band tenodesis, and patellar ligament/tendon repair. |
| Summary of<br>Technologies: | The Ti - Screw Anchor SP has the same intended use, functional<br>characteristics, and uses the same titanium alloy as the predicate Metal<br>Screw Anchor device. |
| Non-Clinical Testing: | Mechanical testing found the Ti - Screw Anchor SP to be substantially<br>equivalent to the predicate Harpoon Suture Anchor and Metal Screw<br>Anchor. |
| Clinical Testing: | No clinical testing was provided as a basis for substantial equivalence. |

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All trademarks are property of Biomet, Inc.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2004

Mr. Gary Baker Regulatory Specialist Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K042460 Device Name: Ti - Screw Anchor SP Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: MBI, GAS, GAT Dated: September 9, 2004 Received: September 10, 2004

Dear Mr. Baker:

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 forth 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 - Mr. Gary Baker

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 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/cdrb/dsma/dsmamain.html.

Sincerely yours,

Mark McMillan

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

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## Indications for Use

510(k) Number (if known): K042460

Device Name: Ti - Screw Anchor SP

Indications For Use: The Ti-Screw Anchor SP is indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:

Shoulder Indications - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

Wrist/Hand Indications - Ulnar/radial collateral ligament reconstruction.

Ankle/Foot Indications - Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.

Elbow Indications - Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.

Knee Indications - Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

ffice of Device Evaluation (ODE) Concurrence of CDR

for Mark N Millheuser

Restorative. and Neurological Devices

**510(k) Number** K042460

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