SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR

K093428 · Smith & Nephew Endoscopy, Inc. · MBI · Dec 17, 2009 · Orthopedic

Device Facts

• Record ID: K093428
• Device Name: SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR
• Applicant: Smith & Nephew Endoscopy, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Dec 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew Knotless Instability Anchor is intended for use in the attachment or 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 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 Knee Extra-capsular repairs ( Medial collateral ligament, Lateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotibial band tenodesis

Device Story

The Smith & Nephew Knotless Instability Anchor is a tap-in surgical fastener designed for soft tissue-to-bone reattachment. Manufactured from PEEK, the device is supplied pre-assembled on an inserter. It is used by surgeons in clinical settings (OR) to facilitate knotless tissue fixation during orthopedic procedures, including shoulder stabilization, hip capsule repair, and various ligament/tendon reconstructions in the extremities. By eliminating the need for traditional knots, the device simplifies the surgical repair process, potentially reducing operative time and improving tissue reapproximation. The surgeon manually deploys the anchor into the bone to secure the soft tissue, providing mechanical stability for the repair site.

Clinical Evidence

Bench testing only. Biomechanical performance parameters were compared to predicate devices to demonstrate substantial equivalence.

Technological Characteristics

Material: PEEK. Form factor: Tap-in anchor, pre-assembled on an inserter. Principle: Mechanical bone fixation fastener. Sterilization: Not specified.

Indications for Use

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

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 2.3PK (K071586)
• Smith & Nephew TwinFix PK FP (K073509)
• Mitek BioKnotless anchor (K002639)

Submission Summary (Full Text)

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

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

- We are smith&nephew
K093428 (1/2)

1

DEC 1 7 """

#### SECTION IV

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

# 510(k) Submission for the Smith & Nephew Knotless Instability Anchor

Date Prepared:

October 30, 2009

- A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810

### B. Company Contact

Kathy Reddig Regulatory Affairs Specialist II 978-749-1321 Phone [phone] Fax

#### C. Device Name

| Trade Name: - | Smith & Nephew Knotless Instability Anchor |
|----------------------|----------------------------------------------------|
| Common Name: | Fastener, Fixation, Non-degradable, Soft Tissue |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |

#### Predicate Devices D.

The Smith & Nephew Knotless Instability Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: Smith & Nephew BIORAPTOR 2.3PK , Smith & Nephew TwinFix PK FP, and the Mitek BioKnotless anchor.

#### E. Description of Device

The Smith & Nephew Knotless Instability Anchor is a tap in anchor that is manufactured from PEEK and comes pre-assembled on an inserter, sized appropriately to facilitate both hip and shoulder procedures. The device allows for knotless tissue attachment and reapproximation in surgical repairs of soft tissue to bone.

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K093428(2/2)

#### F. Intended Use

The Smith & Nephew Knotless Instability Anchor is intended for use in the attachment or 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

#### 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

#### Knee

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

#### ﻦ Comparison of Technological Characteristics

The Smith & Nephew Knotless Instability Anchor is substantially equivalent in intended use, technological characteristics, and are as safe and as effective as their currently marketed predicate devices, the Smith & Nephew BIORAPTOR 2.3PK(K071586), the Smith & Nephew TwinFix FootPrint PK(K073509), and the Mitek BioKnotless(K002639).

#### H. Summary Performance Data

The performance testing demonstrates that the biomechanical parameters of the Smith & Nephew Knotless Instability Anchor are substantially equivalent to the corresponding parameters of the Smith & Nephew BIORAPTOR 2.3PK(K071586), the Smith & Nephew TwinFix FootPrint PK(K073509), and the Mitek BioKnotless (K002639).

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of flowing lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Smith and Nephew Endoscopy, Inc. % Ms. Kathy Reddig Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810

Re: K093428

Trade/Device Name: Smith & Nephew Knotless Instability Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: October 30, 2009 Received: November 3, 2009

Dear Ms. Reddig:

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.

DEC 1 7 2009

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 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 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.

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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,

Joxita 7

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): _ K093428

Smith & Nephew Knotless Instability Anchor Device Name:

Indications For Use:

The Smith & Nephew Knotless Instability 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 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 x x

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)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sonetti for men
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093428

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