ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS

K122059 · Smith & Nephew, Inc. · MBI · Mar 18, 2013 · Orthopedic

Device Facts

• Record ID: K122059
• Device Name: ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS
• Applicant: Smith & Nephew, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Mar 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew, Inc. SUTUREFIX Ultra Suture Anchor is intended for the secure fixation of soft tissue to bone for the following indications: Hip Hip capsule repair (Acetabular labrum repair/reconstruction) 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 repair/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 collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Illiotibial band tenodesis

Device Story

SUTUREFIX Ultra Suture Anchor; soft tissue-to-bone fixation device. Consists of soft suture anchor with pre-attached non-absorbable suture(s) pre-loaded on insertion device. Used by orthopedic surgeons in clinical/OR settings. Device provides mechanical securement of soft tissue to bone during reconstructive or repair surgeries. Surgeon uses insertion device to place anchor; provides immediate fixation strength. Benefits patient by enabling stable tissue reattachment, facilitating healing in orthopedic repairs.

Clinical Evidence

Bench testing only. Performance data confirms device meets specifications for insertion strength and pull-out strength.

Technological Characteristics

Soft suture anchor with non-absorbable suture(s). Pre-loaded on insertion device. Single-use, sterile. Mechanical fixation principle.

Indications for Use

Indicated for patients requiring soft tissue-to-bone fixation in orthopedic procedures including hip capsule repair, shoulder capsular stabilization, rotator cuff repair, biceps tenodesis, foot/ankle ligament/tendon reconstruction, bunionectomy, elbow/wrist/hand ligament/tendon repair, and knee extra-capsular/patellar repairs.

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 (K121018)
• JuggerKnot® Soft Anchors (K110145)

Submission Summary (Full Text)

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Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA T 978-749-1000 F 978-749-1443 www.smith-nephew.com

- We are **smith&nephew**

# K122059

# page 1 of 2

MAR 1 8 2013

| Submitter Information | Contact Information |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Smith & Nephew, Inc.<br>150 Minuteman Road<br>Andover, MA 01810 | Anne-Marie Keefe<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |

| Device Name & Classification | |
|------------------------------|------------------------------------------------|
| Proprietary Name | SUTUREFIX Ultra Suture Anchor |
| Common Name | Soft Tissue Fixation Device |
| Classification Name | Fastener, fixation, nondegradable, soft tissue |
| Classification Regulation | 21 CFR 888.3040 |
| Class | II |
| Product Code(s) | MBI |
| Panel | Orthopedic |

#### Device Description

The Smith & Nephew SUTUREFIX Ultra Suture Anchor is intended to provide secure . fixation of soft tissue to bone. The device consists of a soft suture anchor with an attached non-absorbable suture(s) preassembled onto an insertion device. The SUTUREFIX Ultra Suture Anchors are available pre-loaded with either one #2 suture or with two #1 sutures. This device is provided sterile, for single use only.

## Predicate Devices ·

| Manufacturer | Description | Submission Number | Clearance Date |
|----------------------|--------------------------------|-------------------|----------------|
| Smith & Nephew, Inc. | BIORAPTOR 2.3 PK Suture Anchor | K121018 | June 22, 2012 |
| Biomet, Inc. | JuggerKnot® Soft Anchors | K110145 | March 4, 2011 |

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T 978-749-1000 F 978-749-1443 www.smith-nephew.com

#### K122059 page 2 of 2

#### Intended Use

The Smith & Nephew, Inc. SUTUREFIX Ultra Suture Anchor is intended for the secure fixation of soft tissue to bone for the following indications:

#### Hip

Hip capsule repair (Acetabular labrum repair/reconstruction)

#### 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 repair/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 collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Illiotibial band tenodesis

#### Technological Characteristics

The Smith & Nephew SUTUREFIX Ultra Suture Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the legally marked predicate devices in commercial distribution and raises no new issues of safety and efficacy.

#### Summary Performance Data

Performance data demonstrates that the SUTUREFIX Ultra Suture Anchor has met performance specifications for insertion strength and pull-out strength and therefore, is considered substantially equivalent to the currently marketed predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

March 18, 2013

Smith & Nephew, Incorporated % Ms. Anne-Marie Keefe Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810

Re: K122059

Trade/Device Name: SUTUREFIX Ultra Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 7, 2013 Received: February 12, 2013

Dear Ms. Keefe:

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. 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 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

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#### Page 2 - Ms. Anne-Marie Keefe

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Erin DKeith

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

Enclosure

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### Premarket Notification Indications for Use Statement

510(k) Number (if known):K122059

SUTUREFIX Ultra Suture Anchor Device Name:

Indications for Use:

The Smith & Nephew SUTUREFIX Ultra Suture Anchor is intended for the secure fixation of soft tissue to bone for the following indications:

#### Hip

Hip capsule repair (Acetabular labrum repair/reconstruction)

#### 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 repair/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

Prescription Use X __ (Part 21 CFR 801.109)

AND/OR

Over-the-Counter Use (Optional Format 1-2-96)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

# Elizabet际圈Ærank -S

Division of Orthopedic Devices