HITCH LACTOSORB SUTURE ANCHOR

K061657 · Arthrotek, Inc. · JDR · Jul 25, 2006 · Orthopedic

Device Facts

• Record ID: K061657
• Device Name: HITCH LACTOSORB SUTURE ANCHOR
• Applicant: Arthrotek, Inc.
• Product Code: JDR · Orthopedic
• Decision Date: Jul 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for the Hitch™ LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, 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 Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulnar or radial collateral ligament reconstruction. Knee: Extracapsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.

Device Story

Hitch™ LactoSorb® Suture Anchor is a resorbable implant for soft tissue reattachment. Device consists of L-Lactide/Glycolide material preloaded with #2 polyethylene surgical sutures. Surgeon inserts anchor into bone via pre-drilled hole or by screwing into tapped pre-drilled hole. Used in orthopedic procedures (shoulder, wrist/hand, elbow, knee) to secure soft tissue to bone. Provides mechanical fixation during healing process; material resorbs over time. Intended for use by surgeons in clinical/OR settings.

Clinical Evidence

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

Technological Characteristics

Resorbable L-Lactide/Glycolide material; preloaded with #2 polyethylene surgical sutures; mechanical fixation via push-in or screw-in insertion into bone.

Indications for Use

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

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

• Soft Tissue Screw and Washer (K012572)

Submission Summary (Full Text)

{0}------------------------------------------------

K061657 page 14/

Image /page/0/Picture/1 description: The image shows the word "BIOMET" in a stylized, blocky font. The letters are bold and black, with the exception of the letter "T", which has horizontal lines running through it. The overall design is geometric and modern.

JUL 25 2006

## 510(k) Summary

Arthrotek, Inc., Applicant/Sponsor: (A Wholly Owned Subsidiary of Biomet, Inc.) 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

May 25, 2006

Contact Person: Lester F. Padilla

Hitch™ LactoSorb® Suture Anchor Proprietary Name:

Common Name: Suture anchor

Classification Name: Fastener, fixation, biodegradable, soft tissue (21 CFR 888.3030)

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

Soft Tissue Screw and Washer (K012572) ●

## Device Description:

Preparation Date:

The Hitch™ LactoSorb® Suture Anchor is made with an L-Lactide / Glycolide resorbable material, preloaded with #2 polyethylene surgical sutures. The disign enables the user to insert the implantable anchor by pushing the tip into the bone either through a pre-drilled hole, or by screwing it in through a tapped pre-drilled hole.

## Intended Use:

Indications for the Hitch™ LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, 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 tenodesis, deltoid repair.

Wrist/Hand: Scapholunate ligament reconstruction

Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.

Knee: Extracapsular repair: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, illotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.

Summary of Technologies: The Hitch™ LactoScrb® Suture Anchor has similar or identical technological characteristics (design, materials, and 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.

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

All trademarks are property of Arthrotek, Inc.

MAILING ADDRESS PO. Box 587 Warsaw, IN 46581 05837

트

SHIPPING ADDRESS 56 D. Bell Drive Warsaw, IN 46582

搜

( )['1'] '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' '1' ' 5 / . ! . ! ( s / . ( s ( x ( x ( x ( x ( x ( x ( x ( x ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) (

5^1
574267-137

IC MAIL [e-mail]

{1}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 25 2006

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

Re: K061657

Trade/Device Name: Hitch™ 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 25, 2006 Received: June 13, 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

{2}------------------------------------------------

Page 2 – Mr. Lester F. Padilla

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. 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/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Barbara Buehrle
for

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indlications for Use

510(k) Number (if known): K061657

Device Name: Hitch™ LactoSorb® Suture Anchar

Indications for Use:

Indications for the Hitch™ LactoSorb® Suture Anchor include use in soft tissue reattachment Indications for the meet - Eactober books, 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

Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.

Knee: Extracapsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

estorative.

**510(k) Number** K061657

Page 1 of 1