BIORAPTOR 2.3 PK SUTURE ANCHOR

K071586 · Smith & Nephew Inc., Endoscopy Division · MBI · Aug 17, 2007 · Orthopedic

Device Facts

• Record ID: K071586
• Device Name: BIORAPTOR 2.3 PK SUTURE ANCHOR
• Applicant: Smith & Nephew Inc., Endoscopy Division
• Product Code: MBI · Orthopedic
• Decision Date: Aug 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These suture anchors are intended for the fixation of soft tissue to bone in the Hip, Shoulder, Foot, Ankle, Elbow, Wrist, Hand and Knee as follows: Hip Hip capsule repair - Acetabular labrum reattachment Shoulder Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Elbow, Wrist, and Hand Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair 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 Foot and Ankle Rotator cuff tear repairs Biceps tenodesis Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy

Device Story

Non-bioabsorbable 2.3 mm suture anchor; manufactured from PEEK Optima polymer; includes preassembled ultra high molecular weight braided polyethylene #2 suture and stainless steel inserter. Used by orthopedic surgeons in clinical/OR settings for soft tissue-to-bone fixation. Device provides mechanical anchor point in bone to secure tendons/ligaments during reconstructive surgery. Benefits include stable fixation of soft tissue to facilitate healing. No electronic or software components.

Clinical Evidence

Bench testing only; performance testing demonstrated insertion and fixation properties equivalent to predicate devices.

Technological Characteristics

Material: PEEK Optima polymer; Suture: ultra high molecular weight braided polyethylene; Inserter: stainless steel. Mechanical fixation device. No software, electronics, or energy source.

Indications for Use

Indicated for reattachment of soft tissue to bone in hip, shoulder, elbow, wrist, hand, knee, foot, and ankle for patients requiring surgical repair of ligaments, tendons, or capsules (e.g., Bankart, SLAP, rotator cuff, Achilles, bunionectomy).

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

• BIORAPTOR 2.3 OC Suture Anchor (K063726)
• KINSA Suture Anchor (K061154)

Submission Summary (Full Text)

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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.

#### BIORAPTOR PK Suture Anchor

Date Prepared: 06 AUG 2007

#### A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover, MA 01810

#### B. Company Contact

Julie Acker, RAC Regulatory Affairs Specialist Phone: [phone] FAX: [phone]

#### C. Device Name

| Trade Name: | BIORAPTOR 2.3 PK Suture Anchor |
|----------------------|----------------------------------------------------|
| Common Name: | Fastener, fixation, non-degradable, soft tissue |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Product Code: | MBI |
| Regulation Number: | 21 CFR §888.3040 |

#### D. Predicate Devices

The Smith & Nephew BIORAPTOR 2.3 PK Suture Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: BIORAPTOR 2.3 OC Suture Anchor (K063726) and KINSA Suture Anchor (K061154).

#### Description of Device E.

Non-bioabsorbable 2.3 mm suture anchor manufactured from PEEK Optima® polymer with attached non-bioabsorbable ultra high molecular weight braided polyethylene #2 suture preassembled to a stainless steel inserter.

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## F. Intended Use

These suture anchors are intended for the fixation of soft tissue to bone in the Hip, Shoulder, Foot, Ankle, Elbow, Wrist, Hand and Knee as follows:

#### Hip

Hip capsule repair

- Acetabular labrum reattachment
#### Shoulder

Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs

# Elbow, Wrist, and Hand

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

#### 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

#### Foot and Ankle

Rotator cuff tear repairs Biceps tenodesis

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

## G. Comparison of Technological Characteristics

The Smith & Nephew BIORAPTOR PK Suture Anchor is substantially equivalent to the Smith & Nephew BIORAPTOR OC Suture Anchor (K063726). The BIORAPTOR PK anchor design is identical to that of the predicate anchor (K063726). The only difference is the anchor material which is a non-biodegradable polymer. This material is identical to that used in the Smith & Nephew KINSA Suture Anchor (K061154).

### H. Summary Performance Data

The performance testing conducted demonstrates that the insertion and fixation properties of the BIORAPTOR PK anchor are substantially equivalent to the Smith & Nephew BIORAPTOR OC and the Smith & Nephew KINSA anchors.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. % Ms. Julie Acker, RAC 150 Minuteman Rd. Andover, MA 01810

AUG 1 7 2007

Re: K071586

Trade/Device Name: BIORAPTOR 2.3 PK Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: August 6, 2007 Received: August 7, 2007

Dear Ms. Acker:

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. Julie Acker

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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buchm

Mark N. Me 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

K071586

510(k) Number (if known):

Device Name: BIORAPTOR 2.3 PK Suture Anchor

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

Elbow, Wrist, and Hand

reconstructions

Knee

Biceps tendon reattachment

Lateral epicondylitis repair

Extra-capsular repairs: - Medial collateral ligament

- Lateral collateral ligament

- Posterior oblique ligament

Iliotibial band tenodesis

Patellar realignment and tendon repairs

- Vastus medialis obliquous advancement

Ulnar or radial collateral ligament

Hip Hip capsule repair - Acetabular labrum reattachment

#### Shoulder

- Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs
#### Foot and Ankle

Biceps tenodesis

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

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)

Sabara Boehn

Division of General. Restorative. and Neurological Devices

510(k) Number K071586

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