MULTITAK SS SUTURE SYSTEM

K971144 · Bonutti Research · MBI · Jun 25, 1997 · Orthopedic

Device Facts

• Record ID: K971144
• Device Name: MULTITAK SS SUTURE SYSTEM
• Applicant: Bonutti Research
• Product Code: MBI · Orthopedic
• Decision Date: Jun 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The devices are intended for soft tissue to bone suture fixation for the following indications: Shoulder - Bankart lesion repairs - S.L.A.P. lesion repairs - Acromio-clavicular Repairs - Capsular Shift/Capsulolabral Reconstruction - Deltoid Repair - Rotator cuff tear repairs - Biceps tenodesis Foot and Ankle - Medial/lateral repairs, reconstructions - Achilles tendon repairs - Midfoot and forefoot repairs - Hallux Valgus reconstruction Elbow - Ulnar or radial collateral ligament reconstructions - Tennis elbow repair - Biceps tendon reattachment Knee - Extra-capsular repairs: - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament - Iliotibial band tenodesis - Patellar tendon repair - VMO advancement - Joint capsule closure Hand/Wrist - Collateral ligament repair (Gamekeeper's Thumb) - Scapholunate ligament reconstruction - Tendon transfers in phalanx - Volar plate reconstruction

Device Story

Tubular soft tissue anchor preassembled with USP size 2-0 through 2 braided polyester suture; delivered into predrilled bone hole via dedicated introduction device; used by surgeons in clinical settings to secure soft tissue to bone; provides mechanical fixation for various orthopedic repairs; benefits patient by enabling stable tissue reattachment.

Clinical Evidence

Bench testing only. Pullout strength testing compared to suture-only reattachment technique; insertion testing performed to verify locking mechanism at all indicated anatomical sites.

Technological Characteristics

Tubular anchor; braided polyester suture (USP 2-0 to 2); mechanical fixation; manual insertion via introduction device.

Indications for Use

Indicated for patients requiring soft tissue to bone suture fixation in shoulder, knee, foot, ankle, elbow, and hand/wrist 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

• Multitak SS Suture System (K934183)
• GII Anchor System (K953877)
• Mini QuickAnchor (K930892)
• Mini QuickAnchor (K904436)
• Statak Soft Tissue Attachment Device (K926384)
• Statak Soft Tissue Attachment Device (K962397)

Submission Summary (Full Text)

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K97 1144 JUN 25 1997

# Summary of Safety and Effectiveness
## Multitak Suture System™

- **Submitted by**
Bonutti Research, Inc.
1303 Evergreen Ave.
Effingham, IL 62401

- **Prepared by**
Lynnette Whitaker
Director
Regulatory Affairs/Quality Assurance

- **Date**
June 24, 1997

- **Trade Name**
*Multitak* Suture System

- **Common Name**
Soft Tissue Anchor

- **Classification Name**
21 CFR 888.3040, Smooth or Threaded Metallic Bone Fixation Fastener

- **Predicate Devices**
- *Multitak* SS Suture System, manufactured by Bonutti Research, K934183.
- GII Anchor System, manufactured by Mitek Surgical Products, Inc., K953877.
- Mini QuickAnchor, manufactured by Mitek Surgical Products, Inc., K930892 and K904436.
- Statak Soft Tissue Attachment Device, manufactured by Zimmer, Inc., K926384, cleared November 16, 1993 and K962397, cleared August 27, 1996.

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- Device Description

The anchor is tubular in shape and is preassembled threaded with USP size 2-0 through 2 braided polyester suture. An Introduction Device holds the anchor and delivers it into the bone through a predrilled hole. The sutures can then be used to secure the soft tissue to the bone.

- Intended Use

The devices are intended for soft tissue to bone suture fixation for the following indications:

**Shoulder**
- Bankart lesion repairs
- S.L.A.P. lesion repairs
- Acromio-clavicular Repairs
- Capsular Shift/Capsulolabral Reconstruction
- Deltoid Repair
- Rotator cuff tear repairs
- Biceps tenodesis

**Foot and Ankle**
- Medial/lateral repairs, reconstructions
- Achilles tendon repairs
- Midfoot and forefoot repairs
- Hallux Valgus reconstruction

**Elbow**
- Ulnar or radial collateral ligament reconstructions
- Tennis elbow repair
- Biceps tendon reattachment

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

**Hand/Wrist**
- Collateral ligament repair (Gamekeeper's Thumb)
- Scapholunate ligament reconstruction
- Tendon transfers in phalanx
- Volar plate reconstruction

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## Performance Data

The *Multitak* Suture System was compared in pullout testing to the predicate device and found to demonstrate pullout strengths superior to those of a suture only reattachment technique. Insertion testing was performed to verify insertion and locking at all indicated sites.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Lynnette Whitaker, RAC
Director, Regulatory Affairs/Quality Assurance
Bonutti Research, Inc.
1303 Evergreen Avenue
Effingham, Illinois 62401

JUN 25 1997

Re: K971144
Multitak SS Suture System®
Regulatory Class: II
Product Codes: MBI and HWC
Dated: March 27, 1997
Received: March 28, 1997

Dear Ms. Whitaker:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Lynnette Whitaker, RAC

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Marie Afdwoede, M.S., PT
for Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K971144

Device Name: MULTITAK SUTURE SYSTEM

Indications For Use:

The Multitak Suture System is intended for soft tissue to bone suture fixation for the following indications:

**Shoulder**
- Bankart lesion repairs
- S.L.A.P. lesion repairs
- Acromio-clavicular repairs
- Capsular shift/capsulolabral reconstruction
- Deltoid repair
- Rotator cuff tear repairs
- Biceps tenodesis

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

**Foot and Ankle**
- Medial/lateral repairs, reconstructions
- Achilles tendon repairs
- (Gamekeeper's Thumb)
- Midfoot and forefoot repairs
- Hallux valgus reconstruction

**Hand/Wrist**
- Collateral ligament repair
- Scapholunate ligament reconstruction
- Tendon transfers in phalanx
- Volar plate reconstruction

**Elbow**
- Ulnar or radial collateral ligament reconstructions
- Tennis elbow repair
- Biceps tendon reattachment

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mave A. Calvoeder MS PT for cmw.

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971144

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐
(Optional Format 1-2-96)

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