PLC SUTURE ANCHOR

K063726 · Smith & Nephew Inc., Endoscopy Div. · HRS · Mar 6, 2007 · Orthopedic

Device Facts

• Record ID: K063726
• Device Name: PLC SUTURE ANCHOR
• Applicant: Smith & Nephew Inc., Endoscopy Div.
• Product Code: HRS · Orthopedic
• Decision Date: Mar 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew PLC suture anchors are 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 or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis Foot and Ankle Hallux valgus repairs Medial or lateral instablility repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy Elbow reconstructions Ulnar or radial collateral ligament Lateral epicondylitis repair Biceps tendon reattachment Knee Extra-capsular repairs: medial collateral ligament lateral collateral ligament posterior oblique ligament Patellar realignment and tendon repairs: vastus medialis obliquous advancement Iliotibial band tenodesis Hip Capsular repair Acetabular labral repair

Device Story

PLC Suture Anchor is a 2.3 mm preloaded suture anchor; manufactured from osteoconductive biodegradable PLC material; includes ultra-high molecular weight polyethylene suture; mounted on stainless steel inserter. Used by surgeons in orthopedic procedures to reattach soft tissue to bone. Device functions as a mechanical fixation fastener. Benefits include secure tissue-to-bone fixation during healing, with material designed to be osteoconductive.

Clinical Evidence

Bench and animal testing performed to demonstrate substantial equivalence to the predicate device. No human clinical data provided.

Technological Characteristics

2.3 mm suture anchor; material: PLC (osteoconductive biodegradable); suture: ultra-high molecular weight polyethylene; inserter: stainless steel. Mechanical fixation device.

Indications for Use

Indicated for reattachment of soft tissue to bone in shoulder, foot, ankle, elbow, knee, and hip procedures requiring ligament, tendon, or capsular repair/reconstruction.

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

• Smith & Nephew BioRaptor Suture Anchor (K053344)

Submission Summary (Full Text)

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K063726 page 1 of 2

### SECTION IV MAR 06 2007 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.

## PLC Suture Anchor

Date Prepared: March 5, 2007

## A. Submitter's Name:

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

# B. Company Contact

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

## C. Device Name

| Trade Name: | PLC Suture Anchor |
|----------------------|------------------------------------------------|
| Common Name: | Suture Anchor |
| Classification Name: | Fastener, Fixation,<br>degradable, soft tissue |

## D. Predicate Devices

The PLC Suture Anchor is substantially equivalent to the Smith & Nephew BioRaptor Suture Anchor (K053344).

#### Description of Device E.

Preloaded 2.3 mm suture anchor manufactured from PLC incorporating ultra high molecular weight polyethelene suture on a stainless steel inserter.

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page 2 of 2

#### F. Indications for Use

The Smith & Nephew PLC suture anchors are 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 or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis

Foot and Ankle

Hallux valgus repairs Medial or lateral instablility repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy

#### Elbow

reconstructions Ulnar or radial collateral ligament Lateral epicondylitis repair Biceps tendon reattachment

#### Knee

Extra-capsular repairs: medial collateral ligament lateral collateral ligament posterior oblique ligament Patellar realignment and tendon repairs: vastus medialis obliquous advancement Iliotibial band tenodesis

### Hip

Capsular repair Acetabular labral repair

## G. Comparison of Technological Characteristics

The Smith & Nephew PLC Suture Anchor is substantially equivalent to the Smith & Nephew, Inc BIORAPTOR Suture Anchor. The only major difference is the material of the anchor which is PLC, an osteoconductive biodegradable material.

## H. Summary Performance Data

The performance testing conducted includes bench and animal testing that demonstrates substantial equivalence to the Smith & Nephew, Inc BIORAPTOR Suture Anchor.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. Endoscopy Division c/o Ms. Deana Boushell Principal Regulatory Affairs Specialist 150 Minuteman Road Andover, MA 01810

MAR 0 6 2007

Re: K063726

Trade/Device Name: PLC Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: December 14, 2006 Received: December 15, 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" (21 CFR 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

[signature]

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

Enclosure

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Ko6376

§I.D

## Indications for Use

510(k) Number (if known):

Device Name: PLC Suture Anchors

Indications For Use:

The Smith & Nephew PLC suture anchors are intensed 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 or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis

Foot and Ankle Hallux valgus repairs Medial or lateral instablility repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy

Elbow

Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Knee

Extra-capsular repairs: medial collateral ligament lateral collateral ligament posterior oblique ligament Patellar realignment and tendon repairs: vastus medialis obliquous advancement Iliotibial band tenodesis

## Hip

Capsular repair Acetabular labral repair

Prescription Use __ x_

(Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ Yo

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Davice Evaluation (ODE)

Db. Tho

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

510(k) Number

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