BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS

K102660 · Smith & Nephew Endoscopy, Inc. · MBI · Dec 13, 2010 · Orthopedic

Device Facts

• Record ID: K102660
• Device Name: BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS
• Applicant: Smith & Nephew Endoscopy, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Dec 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BIORAPTOR Curved 2.3 PK 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 Rotator cuff tear repairs Biceps tenodesis Foot and Ankle Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy Elbow, Wrist, and Hand Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Knec Extra-capsular repairs: - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament Patellar realignment and tendon repairs – Vastus medialis obliquous advancement Iliotibial band tenodesis

Device Story

Nonabsorbable 2.3 mm suture anchor; manufactured from PEEK; preloaded with non-absorbable ultra high molecular weight braided polyethylene #2 suture; preassembled to flexible stainless steel inserter. Used by surgeons in orthopedic procedures to fix soft tissue to bone. Device provides mechanical fixation; surgeon inserts anchor into bone; suture secures tissue. Benefits include stable reattachment of soft tissue to bone to facilitate healing.

Clinical Evidence

Bench testing only. Performance testing demonstrated that insertion, pull-out, and suture slide properties are substantially equivalent to the predicate device.

Technological Characteristics

2.3 mm suture anchor; material: PEEK; suture: non-absorbable ultra high molecular weight braided polyethylene #2; inserter: flexible stainless steel. Mechanical fixation device; non-sterile/sterile status not specified (implied sterile for surgical use).

Indications for Use

Indicated for reattachment of soft tissue to bone in hip, shoulder, elbow, wrist, hand, knee, foot, and ankle procedures requiring fixation of ligaments, tendons, or capsules.

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 PK Suture Anchor (K071586)

Submission Summary (Full Text)

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>< We are smith&nephew

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

978 749 1000 978 749 1599 Fax www.smith-nephew.com

DEC 1 3 2010

# 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 Curved 2.3 PK Suture Anchor

Date Prepared: September 13, 2010

#### A. Submitter's Name:

. Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover, MA 01810

#### B. Company Contact

Kathleen Solomon

Regulatory Affairs Specialist II

Phone: [phone]

FAX: [phone]

#### C. Device Name

| Trade Name: | BIORAPTOR Curved 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 Device

The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchors are substantially equivalent in Indication for Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: BIORAPTOR 2.3 PK Suture Anchor (K071586).

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## E. Description of Device

The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor is nonabsorbable 2.3 mm suture anchor manufactured from PEEK and comes preloaded with non-absorbable ultra high molecular weight braided polyethylene #2 suture preassembled to a flexible stainless steel inserter.

## F. Intended Use

The BIORAPTOR Curved 2.3 PK 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 Rotator cuff tear repairs Biceps tenodesis

#### Foot and Ankle

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

## Elbow, Wrist, and Hand

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

## Knec

Extra-capsular repairs: - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament Patellar realignment and tendon repairs – Vastus medialis obliquous advancement Iliotibial band tenodesis

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## G. Comparison of Technological Characteristics

The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchors are substantially equivalent in indications for use, technological characteristics, and are as safe and as effective as their currently marketed predicate device, the Smith & Nephew BIORAPTOR 2.3 PK Suture Anchor (K071586).

## H. Summary Performance Data

The performance testing demonstrates that the insertion, pull out and suture slide properties of the BIORAPTOR Curved 2.3 PK anchors are substantially equivalent to the Smith & Nephew BIORAPTOR 2.3 PK anchors.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Smith & Nephew Endoscopy, Inc. % Ms. Kathleen Solomon 150 Minuteman Road Andover, MA 01810

# DEC 1 3 2010

Re: K102660

Trade/Device Name: Bioraptor Curved 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: September 13, 2010 Received: September 15, 2010

Dear Ms. Solomon:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21

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#### Page 2 - Ms. Kathleen Solomon

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Foll Rihm Din

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

Enclosure

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Indications for Use

510(k) Number (if known):

K102660 (pg. 1/12)

Device Name: BIORAPTOR Curved 2.3 PK Suture Anchors

DEC 1 3 2010

Indications For Use:

The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications;

## 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 Biceps tenodesis

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 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) 7

(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)

Smith & Nephew Endoscopy BIORAPTOR Curved 2.3 PK Suture Anchor

for M. Melkerson
22-01-13

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102660