ALLTHREAD LACTOSORB SUTURE ANCHOR

K061389 · Arthrotek, Inc. · JDR · Jul 19, 2006 · Orthopedic

Device Facts

• Record ID: K061389
• Device Name: ALLTHREAD LACTOSORB SUTURE ANCHOR
• Applicant: Arthrotek, Inc.
• Product Code: JDR · Orthopedic
• Decision Date: Jul 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for the ALLthread™ LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows: Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction. Ankle/Foot: Lateral Stabilization, medial stabilization, Achilles tendon repair/reconstruction, Halluxvalgus reconstruction, mid- and forefoot reconstruction. Elbow: Tennis elbow repair, Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction. Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair.

Device Story

Resorbable suture anchor; L-Lactide/Glycolide material; preloaded with #2 polyethylene surgical sutures. Used for soft tissue reattachment in orthopedic procedures (shoulder, wrist/hand, ankle/foot, elbow, knee). Inserted by orthopedic surgeons via pre-drilled hole or direct insertion. Provides mechanical fixation for soft tissue to bone; facilitates healing; resorbs over time.

Clinical Evidence

No clinical data provided; substantial equivalence based on non-clinical bench testing.

Technological Characteristics

Material: L-Lactide/Glycolide resorbable polymer. Form factor: Suture anchor preloaded with #2 polyethylene surgical sutures. Insertion: Pre-drilled or direct insertion. Sterilization: Not specified.

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

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• LactoScrew™ Screw Anchor (K033355)

Submission Summary (Full Text)

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K.061389 page 141

Image /page/0/Picture/1 description: The image shows the logo for Biomet Orthopedics, Inc. The word "BIOMET" is in large, bold, sans-serif font, with the letters connected. Below it, in a smaller font, is the text "ORTHOPEDICS, INC.", also in sans-serif font. The logo is simple and professional, likely representing a company in the medical or orthopedic field.

JUL 1 9 2006

## 510(k) Summary

| Preparation Date: | May 15, 2006 |
|----------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant/Sponsor: | Arthrotek, Inc., |
| | (A Wholly Owned Subsidiary of Biomet, Inc.)<br>56 East Bell Drive<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587 |
| Contact Person: | Lester F. Padilla |
| Proprietary Name: | ALLthread™ LactoSorb® Suture Anchor |
| Common Name: | Suture anchor |
| Classification Name: | Fastener, fixation, biodegradable, soft tissue (21 CFR 888.3030) |

## Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

- . LactoScrew™ Screw Anchor (K033355)
Device Description: The ALLthread™ LactoSorb® Suture Anchor is made with an L-Lactide / Glycolice resorbable material, preloaded with #2 polyethylene surgical sutures. The design will enable the anchor to be inserted either without pre-drilling or through a pre-drilled hole.

Intended Use: Indications for the ALLthread™ Lacto:Sorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart repair, SLAP lesion repair, acromio:lavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenndesis, deltoid repair.

Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.

Ankle/Foot: Lateral Stabilization, medial stabilization, Achilles tendon repair/reconstruction, Halluxvalgus reconstruction, mid- and forefoot reconstruction.

Elbow: Tennis elbow repair, Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.

Knee: Medial collateral ligament repair, lateral collateral iigament repair, posterior obligue ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair.

Summary of Technologies: The ALLthread™ Lacto:iorb® Suture Anchors have similar or identical technological characteristics (design, materials, functional performance) as the predicate devices.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicate that the anchors are substantially equivalent to predicate anchors with similar indications for use.

Climical Testing: None provided as a basis for substantial equivalence.

MALING ADDRESS PO. Box 587

Warsaw, IN 46581 0587

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All trademarks are property of Arthrotek, Inc.

SHIPPING ADDRESS 56 E. Bell Drive W:ursaw, IN 46582,

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The seal is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2006

Arthrotek, Inc. % Mr. Lester F. Padilla Regulatory Affairs Associate Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K061389

Trade/Device Name: Allthread™ LactoSorb® Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, HWC Dated: May 15, 2006 Received: May 18, 2006

Dear Mr. Padilla:

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. Lester F. Padilla

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. 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,

Cowboy Muchmore

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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Indication® for Use

Kelli 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: ALLthread™ LactoSorb® Suture Arichor

Indications for Use:

Indications for the ALLthread™ LactoSorb® Suture Anchor include use in soft tissue Indications for the Alexhiedd - Lasters wirity/hand, ankle/foot, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

ligament collateral ligament reconstruction, ulnar/radial Wrist/Hand: Scapholunate reconstruction.

Ankle/Foot: Lateral Stabilization, medial stabilization, Achilles tendon repair/reconstruction, Halluxvalgus reconstruction, mid- and forefoot reconstruction.

Elbow: Tennis elbow repair, Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.

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

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

Over-The-Counter Use NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sarbaro Buchrup for man

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Division of General. Restorative. and Neurological Devices

510(k) Number K061381