TORNIER INSITE FT SUTURE ANCHOR

K110773 · Tornier, Inc. · MBI · Jun 2, 2011 · Orthopedic

Device Facts

• Record ID: K110773
• Device Name: TORNIER INSITE FT SUTURE ANCHOR
• Applicant: Tornier, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jun 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tornier Insite™ FT Suture Anchors are intended for fixation of soft tissue to bone. The Tornier Insite™ FT Suture Anchors are intended for use in the following applications: 1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis. Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction. 2. Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction. 3. Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Illiotibial band tenodesis. 4. Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction. 5. Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.

Device Story

Tornier Insite™ FT Suture Anchor is a fully threaded bone implant for soft tissue-to-bone fixation. Device consists of anchor pre-loaded on insertion tool with attached USP size #2 UHMWPE braided sutures. Available in 4.5mm, 5.5mm, and 6.5mm sizes; materials include PEEK-OPTIMA® and Titanium. Used by surgeons in orthopedic procedures (shoulder, foot/ankle, knee, hand/wrist, elbow). Surgeon manually inserts anchor into bone to secure soft tissue. Provides mechanical fixation strength equivalent to predicate devices. Benefits include reliable soft tissue reattachment during reconstructive surgery.

Clinical Evidence

Bench testing only. Mechanical insertion and pullout testing performed to verify fixation strength compared to predicate devices. No clinical data presented.

Technological Characteristics

Fully threaded bone anchor; PEEK-OPTIMA® (ASTM F-2026) or Titanium (ASTM F-136); USP size #2 UHMWPE braided sutures; sizes 4.5mm, 5.5mm, 6.5mm; ethylene oxide (EO) sterilized.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder (rotator cuff, Bankart, SLAP, biceps tenodesis, AC separation, deltoid, capsular), foot/ankle (stabilization, Achilles, metatarsal, hallux valgus, midfoot), knee (collateral ligaments, patellar tendon, IT band), hand/wrist (scapholunate, collateral ligaments), and elbow (biceps, tennis elbow, collateral ligaments) 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

• INSITE SUTURE ANCHORS (K083268)
• PITON FIXATION IMPLANT SYSTEM (K091870)
• BIORAPTOR 2.3 PK SUTURE ANCHOR (K071586)

Submission Summary (Full Text)

{0}------------------------------------------------

# K110773 (113)

## SECTION 5

## JUN - 2 2011

## 510(k) SUMMARY

## Summary of Safety and Effectiveness information

## Tornier Insite™ FT Suture Anchors

Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92

fixation fastener.

- 1) Device name
Device name: Common name: Classification name: Classification number:

Fastener, fixation, non-degradable, soft tissue Smooth or threaded metallic bone fixation fastener 888.3040 - Smooth or threaded metallic bone

Tornier Insite™ FT Suture Anchors

Product code: MBI

- 2) Submitter
Tornier Inc. 7701 France Avenue South; Suite 600 Edina, MN 55435 Registration Number: 9100540

#### 3) Company contact

Brahim Hadri

Sr. Regulatory affairs Specialist 100 Cummings Center, Suite 444C, Beverly, MA 01915, U.S.A Phone: [phone] ext: 617 1 978-232-9998 Fax: [e-mail]

#### 4) Classification

| Device class: | Class II |
|-----------------------|------------|
| Classification panel: | Orthopedic |
| Product code: | MBI |

510(k) Submission Tornier Insite™ FT Suture Anchors Tornier Inc.

Page 12 of 63

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#### 5) Legally Marketed Device to which Equivalence is Claimed:

The Tornier Insite™ FT Suture Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution:

- TORNIER, INC., INSITE SUTURE ANCHORS K083268 .
- TORNIER, PITON FIXATION IMPLANT SYSTEM K091870 .
- SMITH & NEPHEW INC., ENDOSCOPY DIVISION BIORAPTOR 2.3 PK SUTURE . ANCHOR K071586

#### 6) Device Description

The Tornier Insite™ FT Suture Anchor consists of a bone implant device intended for the fixation of soft tissue to bone. This device is a fully threaded anchor that is available in three sizes (4.5mm, 5.5mm, and 6.5mm) and two materials (PEEK-OPTIMA® and Titanium) for use in a range of fixation applications. The device is assembled pre-loaded onto the insertion device with attached USP size #2 UHMWPE braided sutures.

The Tornier Insite™ FT Suture Anchor is individually packaged and sterilized through ethylene oxide (EO) using appropriate standards and guidelines.

- 7) Materials
.

The Tornier Insite™ FT Suture Anchor is available in two materials: PEEK-OPTIMA® (ASTM F-2026) and Titanium (ASTM F-136) with attached USP size #2 UHMWPE braided sutures.

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#### 8) Indications for Use

The Tornier Insite™ FT Suture Anchors are intended for fixation of soft tissue to bone.

The Tornier Insite™ FT Suture Anchors are intended for use in the following applications:

- 1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis. Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
- Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and 2. Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.
- 3. Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Illiotibial band tenodesis.
- 4. Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
- 5. Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.

#### 9) Summary of Technologies

The technological characteristics (material, design, sizing, indications, sterilization, and fixation strength) of the Tornier Insite™ FT Suture Anchors are similar or identical to the cited predicate devices.

### 10) Nonclinical Testing

Non-clinical laboratory testing was performed to verify the fixation strength of the Tornier Insite™ FT Suture Anchors in mechanical insertion and pullout testing as compared to the predicate devices for specific indications for use. The efficacy of the Tornier Insite™ FT Suture Anchors were compared to the above cited predicates device. The test results indicate that the Tornier Insite™ FT Suture Anchors provide equivalent fixation strength to the above cited predicate devices and would be functional within their intended use.

510(k) Submission Tornier Insite™ FT Suture Anchors Tornier Inc.

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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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

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

Tornier, Inc. % Mr. Brahim Hadri Senior Regulatory Affairs Specialist 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915

Re: K110773

Trade/Device Name: Tornier Insite™ FT 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: April 26, 2011 Received: April 27, 2011

I

Dear Mr. Hadri:

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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

JUN - 2 2011

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Page 2 -- Mr. Brahim Hadri

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/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.

Eric S. Keith.

130

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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# KII0773 (111)

#### INDICATIONS FOR USE

510(k) Number (if known):

### Device Name: Tornier Insite™ FT Suture Anchor

#### Indications for Use

The Tornier Insite™ FT Suture Anchors are intended for fixation of soft tissue to bone.

The Tornier Insite™ FT Suture Anchors are intended for use in the following applications:

- 1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis. Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
- 2. Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot Reconstruction.
- 3. Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Illiotibial band tenodesis.
- 4. Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
- Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar 5. and Radial collateral ligament reconstruction.

AND/OR

Prescription Use _____________________________________________________________________________________________________________________________________________________________ .

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

Eric L. Keith

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

510(k) Submission: Tornier Insite™ FT Suture AndHotek) Number Tornier Inc.

K110773
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