MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM

K052799 · Bonutti Research, Inc. · MAI · Dec 16, 2005 · Orthopedic

Device Facts

• Record ID: K052799
• Device Name: MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM
• Applicant: Bonutti Research, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Dec 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Multitak 6.0 mm Absorbable Anchor System consists of a single use absorbable anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open surgical procedures. The Multitak 6.0 mm Absorbable Anchor System is indicated for use in securing soft tissue to bone in such applications as the following: Shoulder: Bankart lesion repairs Acromio-clavicular repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis SLAP lesion repairs Elbow, Wrist, & Hand: Scapholunate ligament reconstruction Ulnar collateral ligament reconstruction Radial collateral ligament reconstruction Biceps tendon reattachment Knee: Extra-capsular repairs Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure Foot & Ankle: Medial instability repair/reconstruction Lateral instability repair/reconstruction Achilles instability repair/reconstruction Midfoot reconstruction Hallux valgus reconstruction Pelvis: Bladder neck suspension procedures

Device Story

Single-use absorbable suture anchor system; threaded design; 6.0 mm diameter. Used in arthroscopic and open surgical procedures to secure soft tissue to bone. Implanted into predrilled bone sites using disposable or reusable introduction devices. Threaded mechanism engages cancellous bone to provide fixation. Used by surgeons in clinical settings. Benefits include secure soft tissue attachment during orthopedic and reconstructive procedures.

Clinical Evidence

Bench testing only. Performance testing compared mechanical strengths and failure modes of the subject device to predicate devices, demonstrating statistical equivalence.

Technological Characteristics

Material: Poly-L-lactic acid (absorbable). Design: Threaded 6.0 mm anchor. Connectivity: None. Sterilization: Sterile. Software: None.

Indications for Use

Indicated for patients requiring soft tissue-to-bone fixation in shoulder, elbow, wrist, hand, knee, foot, ankle, and pelvic surgical procedures, including ligament and tendon 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

• Stryker BioZip Suture Anchor
• Multitak suture anchors

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the words "Multitak SS" in a bold, sans-serif font. The words are black and are set against a white background. A horizontal line underlines the word "Multitak". Below the line, the words "FROM BONUTTI RESEARCH" are written in a smaller, sans-serif font.

DEC 1 6 2005

## Bonutti Research, Inc. Multitak 6.0 mm Absorbable Anchor System 510(k) Premarket Notification

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The following information is submitted in accordance with the requirements of 21 CFR 807.92:

Patrick Balsmann, MBA, MS, RAC Contact Person: Director, Regulatory/Clinical Affairs & QA Bonutti Research, Inc., P.O. Box 1367, Effingham, Illinois 62401 Phone: [phone], ext. 321 Fax: [phone]

Date Prepared: September 29, 2005

Proprietary Name: Multitak 6.0 mm Absorbable Anchor System

Common Name: Absorbable Soft Tissue Anchor

Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue.

Device Description: The Multitak 6.0 mm Absorbable Anchor System consists of a single use absorbable suture anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open surgical procedures. The 6.0 mm absorbable suture anchor implant is provided sterile and once passed with suture is inscrted into a predrilled bone soft tissue repair site (i.e., rotator cuff repairs) with the use of disposable and reusable introduction devices. The threaded design of the suture anchor implant allows it to be screwed into the bone tissue repair site engaging cancellous bone and acts as an anchor in securing soft tissue to bone.

Indications for Use: The Multitak Splinter 6.0 mm Absorbable Anchor System is indicated for use in sccuring soft tissue to bone in such applications as the following:

## Shoulder:

Bankart lesion repairs Acromio-clavicular repairs Deltoid repairs Rotator cuff tear repairs Bicens tenodesis SLAP lesion repairs

## Elbow, Wrist, & Hand:

Scapholunate ligament reconstruction Ulnar collateral ligament rconstruction radial Collateral ligament reconstruction Biceps tendon reattachment

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

Bonutti Research, Inc. - Multitak 6.0 mm Absorbable Anchor System 510(k) Summary of Safety and Effectiveness Page 2

#### Knee:

Extra-capsular repairs Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure

#### Foot & Ankle:

Medial instability repair/reconstruction Lateral instability repair/reconstruction Achilles instability repair/reconstruction Midfoot reconstruction Hallux valgus reconstruction

Pelvis Bladder neck suspension procedures

Predicate Device(s): The Multitak 6.0 mm Absorbable Anchor System suture anchor implants are similar in intended use and materials to current commercially available poly-L-lactic acid absorbable implants including the Stryker BioZip Suture Anchor. The Multitak 6.0 mm Absorbable Anchor System suture anchor implants are similar in design and intended use to existing Multitak suture anchors determined to be substantially equivalent by FDA.

Predicate Comparison: Performance testing comparing the mechanical strengths and failure modes of the Multitak 6.0 mm Absorbable Anchor System suture anchor implants to predicate devices demonstrated that the anchors are statistically equivalent.

Submitted by:

Patrick Balsmann, MBA, MS, RAC Director, Regulatory/Clinical Affairs & QA

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three distinct head profiles, suggesting a sense of community or collaboration. The bird is positioned within a circular frame, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 16 2005

Mr. Patrick Balsmann, MBA, MS, RAC Director, Regulatory/Clinical Affairs & AQ Bonutti Research, Inc. P. O. Box 1367 Effingham, Illinois 62401

- Re: K052799
Trade/Device Name: Multitak 6.0 mm Absorbable Anchor System Regulation Number: 21 CFR 888.3030 Regulation Name: Fastener, Fixation, Biodegradable, Soft Tissue Regulatory Class: II Product Code: MAI Dated: December 05, 2005 Received: December 06, 2005

Dear Mr. Balsmann:

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

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

### Page 2 - Mr. Patrick Balsmann, MBA, MS, RAC

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" (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/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buehum

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

Enclosure

{4}------------------------------------------------

## Indications for Use

## 510(k) Number (if known): K052799

Device Name: Multitak 6.0 mm Absorbable Anchor System

Indications For Use: The Multitak 6.0 mm Absorbable Anchor System consists of a single use absorbable anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open surgical procedures.

The Multitak 6.0 mm Absorbable Anchor System is indicated for use in securing soft tissue to bone in such applications as the following:

#### Shoulder:

Bankart lesion repairs Acromio-clavicular repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis SLAP lesion repairs

## Knee:

Extra-capsular repairs Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure

## Pelvis

Bladder neck suspension procedures

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

eborah Berland

Concurrence of C

and Neurologica

Page 1 of

**510(k) Number**2052794

Elbow, Wrist, & Hand:

Scapholunate ligament reconstruction Ulnar collateral ligament reconstruction Radial collateral ligament reconstruction Biceps tendon reattachment

#### Foot & Ankle:

Medial instability repair/reconstruction Lateral instability repair/reconstruction Achilles instability repair/reconstruction Midfoot reconstruction Hallux valgus reconstruction