MULTITAK SS

K993115 · Bonutti Research, Inc. · MAI · Dec 17, 1999 · Orthopedic

Device Facts

• Record ID: K993115
• Device Name: MULTITAK SS
• Applicant: Bonutti Research, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Dec 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Multitak SS™ bone anchors are intended for use as load bearing or non-load bearing suture anchors in the attachment of soft tissue to bone in various orthopedic surgical procedures. The bone anchors are provided sterile and are intended for single use with suture up to USP Size No. 2. Multitak SS™ bone anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications: Shoulder: Bankart lesion repairs S.L.A.P. lesions repairs Acromio-clavicular repairs Capsular shift/capsulolabral reconstruction Deltoid repairs Rotator cuff tear repairs Biceps tenodesis Biceps tendon reattachment Elbow: Tennis elbow repair Ulnar or radial collateral ligament reconstruction 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 Midfoot and forefoot repairs Hallus valgus reconstruction Hand/Wrist: Collateral ligament repair (Gamekeeper's Thumb) Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction

Device Story

Cylindrical human cortical bone anchor; 2:1 length-to-diameter ratio; attached to suture. Inserted into predrilled bone hole via disposable or reusable introduction device. Suture tensioning toggles/locks anchor in cancellous bone; curved needle secures soft tissue to bone. Used by orthopedic surgeons in clinical/OR settings. Provides mechanical fixation of soft tissue to bone; facilitates healing. Benefits include biocompatible allograft material; equivalent pullout strength to titanium/stainless steel predicates.

Clinical Evidence

Bench testing only. Performance testing compared pullout strengths and failure modes of cortical bone anchors against titanium predicate anchors, demonstrating statistical equivalence.

Technological Characteristics

Material: Allograft human cortical bone. Form factor: Cylindrical anchor, ~2:1 length-to-diameter ratio. Insertion: Threaded suture loaded on tip of disposable or reusable introduction device. Sterilization: Sterile. No software or electronic components.

Indications for Use

Indicated for orthopedic soft tissue-to-bone fixation in shoulder, elbow, knee, foot/ankle, and hand/wrist procedures. Applicable for patients requiring ligament, tendon, or capsule repair/reconstruction. Prescription use only.

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

• Multitak SS™ titanium suture anchors (K973015)
• Multitak SS™ stainless steel anchor (K934183)

Submission Summary (Full Text)

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#### Bonutti Research, Inc. - Multitak SSTM Bone 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:

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

Date Prepared: September 13, 1999

Proprietary Name: Multitak SSTM Bone anchor

Common Name: Soft Tissue Anchor

Classification Name: Unclassified.

Device Description: Multitak SS™ bone anchors are cylindrical suture anchors with an overall ratio of approximately 2:1, length to diameter. The suture anchors are processed from human cortical bone and provided sterile and are intended for single use. The bone soft tissue anchors with attached suture are inserted into a predrilled bone hole site with a single use disposable or a reusable introduction device. 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(s) is used to secure soft tissue to bone.

Intended Use: The Multitak SS™ bone anchors are intended for use as load bearing or non-load bearing suture anchors in the attachment of soft tissue to bone in various orthopedic surgical procedures. The bone anchors are provided sterile and are intended for single use with suture up to USP Size No. 2.

Multitak SS™ bone anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications:

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

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#### Bonutti Research, Inc. - Multitak SSTM Bone Anchor 510(k) Summary of Safety and Effectiveness Page 2

- Biceps tendon reattachment Elbow: Tennis elbow repair Ulnar or radial collateral ligament reconstruction 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 Midfoot and forefoot repairs Hallus valgus reconstruction Hand/Wrist: Collateral ligament repair (Gamekeeper's Thumb) Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction
Predicate Device: The Multitak SS™ bone anchors are similar in intended use and design to Multitak SS™ titanium suture anchors (K973015.) The bone anchors method of insertion with disposable or reusable introduction devices is similar in design and materials to currently marketed Multitak SS™ introduction devices (K973015 and K934183.) Performance testing comparing the pullout strengths and failure modes of Multitak SSTM cortical bone anchors to titanium anchors demonstrated that the anchors were statistically equivalent.

Predicate Comparison: A chart comparing characteristics of the Multitak SS™ bone anchors to those of the predicate devices is attached.

Submitted by:

Stryker Baker

Patrick Balsmann Manager, QA & Regulatory/Clinical Affairs

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# Bonutti Research, Inc. - Multitak SSTM Bone Anchor 510(k) Premarket Notification Substantial Equivalence Chart

| Device Characteristic | Multitak SSTM Bone Anchor | Multitak SSTM Titanium Anchor | Multitak SSTM Stainless Steel<br>Anchor |
|----------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Current Submission. | K973015. | K934183. |
| Intended Use | Orthopedic procedures involving<br>the attachment of soft tissue to<br>bone. | Orthopedic procedures involving<br>the attachment of soft tissue to<br>bone. | Orthopedic procedures involving<br>the attachment of soft tissue to<br>bone. |
| Indications For Use | Shoulder, elbow, knee, foot/ankle,<br>and hand/wrist soft tissue to bone<br>orthopedic procedures. | Shoulder, elbow, knee, foot/ankle,<br>and hand/wrist soft tissue to bone<br>orthopedic procedures. | Shoulder, elbow, knee, and<br>foot/ankle soft tissue to bone<br>orthopedic procedures. |
| Anchor Design | Cylindrical anchors approximate<br>ratio of 2:1 length to diameter. | Cylindrical anchors approximate<br>ratio of 2:1 length to diameter. | Tubular anchors approximate ratio<br>of 2:1 length to diameter. Single<br>and double anchor tube constructs. |
| Anchor Material | Allograft human cortical bone. | Titanium. | Stainless steel. |
| Anchor Insertion<br>Method | Anchor with threaded suture<br>loaded on to tip of disposable or<br>reusable introduction device. | Anchor with threaded suture<br>loaded on to tip of disposable<br>introduction device. | Anchor with threaded suture<br>loaded on to tip of reusable<br>introduction device. |
| Anchor Provided<br>Sterile | Sterile. | Sterile. | Sterile. |
| Anchor Packaging | One individual anchor preloaded<br>in disposable introduction device.<br>One individual anchor. | One individual anchor preloaded<br>in disposable introduction device. | One individual anchor preloaded<br>in disposable introduction device.<br>One individual anchor. |

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 1999

Mr. Patrick G. Balsmann, MS, RAC Manager, QA & Regulatory/Clinical Affairs Bonutti Research, Incorporated P.O. Box 1367 2600 South Raney Effingham, Illinois 62401

Re: K993115

Trade Name: Multitak SSTM Bone Anchor Regulatory Class: II Product Code: MAI and JDW Dated: September 17, 1999 Received: September 20, 1999

Dear Mr. Balsmann:

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 (OS) 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 - Mr. Patrick G. Balsmann, MS, 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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

hereely yours,

-ilme (l. H. Hage-

Xur James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Bonutti Research, Inc. – Multitak SSTM Bone Anchor 510(k) Premarket Notification

### INDICATIONS FOR USE

Device Name: Multitak SSTM bone anchor.

Indications for Use: Multitak SS™ bone anchors are intended for use as a load bearing or nonload bearing suture anchor used in the attachment of soft tissue to bone in various orthopedic procedures.

Multitak SS™ bone anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications:

| Shoulder: | Bankart lesion repairs |
|-------------|----------------------------------------------------|
| | S.L.A.P. lesions repairs |
| | Acromio-clavicular repairs |
| | Capsular shift/capsulolabral reconstruction |
| | Deltoid repairs |
| | Rotator cuff tear repairs |
| | Biceps tenodesis |
| Elbow: | Biceps tendon reattachment |
| | Tennis elbow repair |
| | 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 |
| | Midfoot and forefoot repairs |
| | Hallus valgus reconstruction |
| Hand/Wrist: | Collateral ligament repair (Gamekeeper's Thumb) |
| | Scapholunate ligament reconstruction |
| | Tendon transfers in phalanx |
| | Volar plate reconstruction |

Prescription Use *X*
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K993115