OSTEORAPTOR SUTURE ANCHOR

K082215 · Smith & Nephew Inc., Endoscopy Division · JDR · Nov 3, 2008 · Orthopedic

Device Facts

• Record ID: K082215
• Device Name: OSTEORAPTOR SUTURE ANCHOR
• Applicant: Smith & Nephew Inc., Endoscopy Division
• Product Code: JDR · Orthopedic
• Decision Date: Nov 3, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew OSTEORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Elbow, Wrist, and Hand: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair; Foot and Ankle: Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy; Hip: Hip capsule repair, Acetabular labrum 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; Shoulder: Capsular stabilization, Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstruction, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis.

Device Story

OSTEORAPTOR Suture Anchor consists of suture anchor with attached non-absorbable suture(s) preassembled to insertion device. Provided sterile for single use. Used by surgeons in clinical settings to reattach soft tissue to bone. Device facilitates fixation during orthopedic procedures; surgeon inserts anchor into bone to secure soft tissue. Benefits patient by providing mechanical fixation for tendon/ligament repairs and reconstructions.

Clinical Evidence

Bench testing only. Performance testing demonstrated that insertion and fixation properties are substantially equivalent to predicate devices.

Technological Characteristics

Suture anchor with attached non-absorbable suture(s) preassembled to an insertion device. Provided sterile for single use. Mechanical fixation device.

Indications for Use

Indicated for reattachment of soft tissue to bone in elbow, wrist, hand, foot, ankle, hip, knee, and shoulder procedures, including ligament/tendon repairs, reconstructions, and capsular stabilizations.

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

• BIORAPTOR 2.9 Anchor (K053344)
• BIORAPTOR 2.3 PK Anchor (K071586)

Submission Summary (Full Text)

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K082215-
P. 1/2

#### SECTION IV

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

NOV - 3 2008

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

#### OSTEORAPTOR® Suture Anchor

Date Prepared: 04 August 2008

- 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: | OSTEORAPTOR Suture Anchor |
|----------------------|------------------------------------------------|
| Common Name: | Suture Anchor |
| Classification Name: | Fastener, Fixation, Biodegradable, Soft Tissue |
| Product Code: | MAI |
| Regulation Number: | 21 CFR & 888.3030 |

#### D. Predicate Devices

The Smith & Nephew OSTEORAPTOR Suture Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: BIORAPTOR 2.9 Anchor (K053344) and BIORAPTOR 2.3 PK Anchor (K071586).

## E. Description of Device

The device consists of a suture anchor with attached non-absorbable suture(s) preassembled to an insertion device. This device is provided sterile, for single use only,

. . . .

Smith & Nephew, Inc. Endoscopy Division

Page 10 of 61

OSTEORAPTOR 510(K)

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## F. Intended Use

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

| Elbow, Wrist, and Hand | Knee |
|-------------------------------------------------------|--------------------------------------------------|
| Biceps tendon reattachment | Extra-capsular repairs: |
| Ulnar or radial collateral ligament reconstructions | - Medial collateral ligament |
| Lateral epicondylitis repair | - Lateral collateral ligament |
| | - Posterior oblique ligament |
| Foot and Ankle | Patellar realignment and tendon repairs |
| Hallux valgus repairs | - Vastus medialis obliquous advancement |
| Medial or lateral instability repairs/reconstructions | lliotibial band tenodesis |
| Achilles tendon repairs/reconstructions | |
| Midfoot reconstructions | Shoulder |
| Metatarsal ligament/tendon repairs/reconstructions | Capsular stabilization |
| Bunionectomy | - Bankart repair |
| | - Anterior shoulder instability |
| Hip | - SLAP lesion repairs |
| Hip capsule repair | - Capsular shift or capsulolabral reconstruction |
| - Acetabular labrum reattachment | Acromioclavicular separation repairs |
| | Deltoid repairs |
| | Rotator cuff tear repairs |
| | Biceps tenodesis |

### G. Comparison of Technological Characteristics

The Smith & Nephew OSTEORAPTOR Suture Anchor is substantially equivalent to the predicate anchors. The proposed and predicate anchors are similar in design, operate on the same principles, have the same indications and intended use, and exhibit similar fixation properties.

#### H. Summary Performance Data

The performance testing conducted demonstrates that the insertion and fixation properties of the OSTEORAPTOR Anchor are substantially equivalent to the predicate devices.

Smith & Nephew, Inc. Endoscopy Division

Page 11 of 61

OSTEORAPTOR 510(K)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is black in color. The eagle is also black and is made up of several curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2008

Smith & Nephew, Inc. Endoscopy Division % Ms. Julie Acker 150 Minuteman Road Andover, Massachusetts 01810

Re: K082215

> Trade/Device Name: Osteoraptor™ 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: JDR, HWC, MAI Dated: August 4, 2008 Received: August 6, 2008

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. Iisting 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. Julie Acker

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Mark M Millman

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

Kop 2215

# 510(k) Number (if known):

# Device Name: OSTEORAPTOR® Suture Anchor

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

#### Elbow, Wrist, and Hand

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

#### Foot and Ankle

Hallux valgus repairs

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

#### Hip

Hip capsule repair

- Acetabular labrum 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
#### 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

| Prescription Use | X |
|----------------------------|---|
| (Per 21 CFR 801 Subpart D) | |

AND/OR

| Over-The-Counter Use | /o |
|------------------------|----|
| (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