MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR

K012465 · Bonutti Research, Inc. · MAI · Oct 29, 2001 · Orthopedic

Device Facts

• Record ID: K012465
• Device Name: MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR
• Applicant: Bonutti Research, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Oct 29, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Multitak Splinter 3.0 mm Resorbable Anchor System consists of a single use bone soft tissue resorbable 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 orthopedic procedures. The Multitak Splinter 3.0 mm Resorbable Anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications: Shoulder: Bankart lesion repairs Acromio-clavicular repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis Elbow: Ulnar or radial collateral ligament reconstruction 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/Lateral repairs/reconstructions Achilles tendon repairs

Device Story

Resorbable suture anchor system for orthopedic soft tissue-to-bone fixation; used in arthroscopic and open procedures. Device consists of poly-L-lactic acid (PLLA) cylindrical anchor with conical tip and two transverse suture holes; preloaded with polyester suture on single-use disposable introduction device. Surgeon drills bone site; inserts anchor; pulls suture to toggle/lock anchor in cancellous bone; uses attached curved needle to secure soft tissue. Facilitates tissue attachment; provides mechanical fixation during healing. Intended for use by orthopedic surgeons in clinical/OR settings.

Clinical Evidence

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

Technological Characteristics

Material: Poly-L-lactic acid (PLLA) resin. Design: Cylindrical anchor, 3.0 mm diameter, conical tip, two transverse suture holes. Delivery: Single-use disposable introduction device. Suture: USP Size No. 2 polyester. Fixation: Mechanical toggle/lock in cancellous bone.

Indications for Use

Indicated for patients requiring soft tissue to bone fixation in orthopedic procedures, including shoulder (Bankart, AC, deltoid, rotator cuff, biceps tenodesis), elbow (collateral ligament reconstruction), knee (extra-capsular, MCL, LCL, posterior oblique, IT band, patellar tendon, VMO, joint capsule), and foot/ankle (medial/lateral repairs, Achilles tendon).

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

• Mitek 3.5 mm Panalok Wedge Absorbable Suture System
• Multitak suture anchors

Submission Summary (Full Text)

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K 0/2465
10Fd

OCT 2 9 2001

## Bonutti Research, Inc. Multitak Splinter 3.0 mm Resorbable Anchor 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, MS, RAC, Contact Person: Director, Regulatory/Clinical Affairs & QA Bonutti Research, Inc., P.O. Box 1367, Effingham, Illinois 62401 Phone: [phone], ext. 321

Date Prepared: July 31, 2001

Proprietary Name: Multitak Splinter 3.0 mm Resorbable Anchor

Common Name: Resorbable Soft Tissue Anchor

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

Device Description: The Multitak Splinter 3.0 mm Resorbable Anchors are cylindrical suture anchors with a conical tip on one end. The resorbable anchors are injection molded from a poly-L-lactic acid resin and have two transverse suture holes. The resorbable implant comes threaded with up to USP Size No. 2 polyester suture preloaded on the tip of a single use disposable introduction device. The resorbable implant and suture is delivered into a predrilled bone site. The suture ends are pulled to engage cancellous bone and to toggle and lock the anchor in bony tissue. A curved needle attached to the suture end is used to secure soft tissue to bone.

Intended Use: The Multitak Splinter 3.0 mm Resorbable Anchor System consists of a single use bone soft tissue resorbable 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 orthopedic procedures.

The Multitak Splinter 3.0 mm Resorbable Anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications:

- Shoulder: Bankart lesion repairs Acromio-clavicular repairs · Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
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Bonutti Research, Inc. - Multitak Splinter 3.0 mm Resorbable Anchor 510(k) Summary of Safety and Effectiveness Page 2

Elbow: Ulnar or radial collateral ligament reconstruction

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/Lateral repairs/reconstructions Achilles tendon repairs

Predicate Device(s): The Multitak Splinter 3.0 mm Resorbable Anchors are similar in intended use and materials to current commercially available poly-L-lactic acid resorbable implants including the Mitek 3.5 mm Panalok Wedge Absorbable Suture System. The Multitak resorbable 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 Splinter 3.0 mm Resorbable Anchors to predicate devices demonstrated that the anchors are statistically equivalent.

Submitted by:

Dicky Belamy

Patrick Balsmann Director, Regulatory/Clinical Affairs & QA

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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OCT 2 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Patrick Balsmann Director, Regulatory/Clinical Affairs and Ouality Assurance Bonutti Research, Inc. P.O. Box 1367 Effingham, Illinois 62401

Re: K012465

Trade/Device Name: Multitak Splinter 3.0 mm Resorbable Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastner Regulatory Class: Class II Product Code: HWC, MAI Dated: July 31, 2001 Received: August 1, 2001

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 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 - Ms. Connie Ficklin

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

e. Mark N. Millburn

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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K01>465

## Bonutti Research, Inc. - Multitak Splinter 3.0 mm Resorbable Anchor 510(k) Premarket Notification

## INDICATIONS FOR USE

Device Name: Multitak Splinter 3.0 mm Resorbable Anchor.

Indications for Use: The Multitak Splinter 3.0 mm Resorbable Anchor System consists of a single use bone soft tissue resorbable 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 orthopedic procedures.

The Multitak Splinter 3.0 mm Resorbable Anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications:

- Bankart lesion repairs Shoulder: Acromio-clavicular repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
Ulnar or radial collateral ligament reconstruction Elbow:

- Extra-capsular repairs Knee: Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure
Medial/Lateral repairs/reconstructions Foot/Ankle: Achilles tendon repairs

R. Mark N. Melleksen

Division Sign-O to rative Division of General and Neurological Decess

510(k) Number

Phone: (USA only) [phone]

Facsimile: (217) 347-33 www.BonuttiResearch.co