KINSA SUTURE ANCHOR

K061154 · Smith & Nephew, Inc. · MBI · Jun 8, 2006 · Orthopedic

Device Facts

• Record ID: K061154
• Device Name: KINSA SUTURE ANCHOR
• Applicant: Smith & Nephew, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jun 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew KINSA Suture Anchor is intended for the reattachment of soft tissue to bone.

Device Story

The KINSA Suture Anchor is a non-degradable soft tissue fixation device used by surgeons to reattach soft tissue to bone. Manufactured from PEEK polymer, the device features an integrated suture knot and a suture loop with a tensioning suture. During surgery, the anchor is implanted into bone; the surgeon passes the suture loop through the tissue and uses the tensioning suture to secure the repair without requiring manual knot tying. This design simplifies the surgical procedure for various shoulder repairs, potentially reducing operative time and improving fixation reliability.

Clinical Evidence

Bench testing only. Performance data demonstrated substantial equivalence to the predicate device (K053344).

Technological Characteristics

Material: PEEK polymer. Form factor: Suture anchor with integrated knot and tensioning suture loop. Function: Mechanical soft tissue-to-bone fixation. Non-degradable.

Indications for Use

Indicated for reattachment of soft tissue to bone in the shoulder, including capsular stabilization, Bankhart repair, anterior shoulder instability repair, SLAP lesion repairs, capsular shift of capsulolabral reconstructions, acromioclavicular separation repairs, deltoid repairs, rotator cuff tear repairs, and biceps tenodesis.

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

• Smith & Nephew BIORAPTOR Suture Anchor (K053344)

Submission Summary (Full Text)

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# JUN - 8 2006

## SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

## Smith & Nephew KINSA Suture Anchor

Date Prepared: April 25, 2006

#### A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810

### B. Company Contact

Deana Boushell Principle Regulatory Affairs Specialist Phone: [phone] FAX: [phone]

### C. Device Name

Trade Name: KINSA Suture Anchor Common Name: Fastener, fixation, non-degradable, soft tissue Classification Name: Fastener, fixation, non-degradable, soft tissue

### D. Predicate Devices

The Smith & Nephew KINSA Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: The Smith & Nephew BIORAPTOR Suture Anchor (K053344).

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#### E. Description of Device

The KINSA Anchor is a suture anchor manufactured from PEEK polymer. The design incorporates a suture knot within the anchor body and a suture loop with a tension suture extending from the top of the anchor. This design allows the surgeon to implant the anchor, pass the suture loop through the tissue and using the tensioning suture, complete the repair without the need for knot tying.

#### F. Intended Use

The Smith & Nephew KINSA Anchor is intended for the reattachment of soft tissue to bone.

## G. Comparison of Technological Characteristics

The Smith & Nephew KINSA Suture Anchor is substantially equivalent in design, materials, function and intended use to the Smith & Nephew BIORAPTOR 2.9 suture anchor, cleared in K053344. The proposed and the predicate devices both have the same intended use, indications for use, suture material.

### H. Summary Performance Data

The performance testing conducted demonstrates substantial equivalence to the Smith & Nephew BIORAPTOR 2.9 Suture Anchor, cleared in K053344 . The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 2006

Smith & Nephew, Inc. % Ms. Deana Boushell Principle Regulatory Affairs Specialist Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810

Re: K061154

Trade/Device Name: Smith & Nephew KINSA Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulation Class: II Product Code: MBI Dated: April 25, 2006 Received: April 26, 2006

Dear Ms. Boushell:

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

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Page 2 - Ms. Deana Boushell

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/dsma/dsmamain.html

Sincerely vours.

elmalli

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

Enclosure

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#### Indications for Use

KOGII54 510(k) Number (if known):

Device Name: Smith & Nephew KINSA Suture Anchor

Indications For Use:

The Smith & Nephew KINSA Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder

Capsular Stabilization Bankhart Repair Anterior Shoulder Instability Repair SLAP Lesion Repairs Capsular Shift of capsulolabral reconstructions Acromioclavicular separation repairs Deltoid Repairs Rotator Cuff Tear repairs Biceps tenodesis

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801 Subpart D)

(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) |
|--------------------------------------------------------|
| (Division Sign-Off) |
| Division of General, Restorative, |
| and Neurological Devices |

510(k) Number_K06(154

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