TORNIER, PITON FIXATION IMPLANT SYSTEM

K091870 · Tornier · MBI · Sep 21, 2009 · Orthopedic

Device Facts

• Record ID: K091870
• Device Name: TORNIER, PITON FIXATION IMPLANT SYSTEM
• Applicant: Tornier
• Product Code: MBI · Orthopedic
• Decision Date: Sep 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tornier PITON™ Fixation Implant is intended for fixation of soft tissue to bone. The PITON™ Implant is intended for use in the following applications: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Illiotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency Hip: Capsular Repair Acetabular Labral Repair

Device Story

PITON™ Fixation Implant System comprises 2.8 mm diameter bone anchor and disposable pre-loaded inserter; secures soft tissue to bone using USP #2 high-strength non-absorbable UHMWPE braided suture. Anchor design features curved titanium base and flared nitinol clip; allows insertion directly into bone without predrilled, punched, or tapped pilot hole. Used by surgeons in clinical settings for various orthopedic repairs (shoulder, foot/ankle, knee, hand/wrist, elbow, hip) and pelvic floor procedures. Device provides mechanical fixation; surgeon manually deploys anchor via inserter to secure tissue; facilitates healing by maintaining tissue-to-bone contact.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing in accordance with applicable FDA guidelines and established history of use for device materials.

Technological Characteristics

2.8 mm diameter bone anchor; materials: titanium (base) and nitinol (clip); suture: USP #2 non-absorbable UHMWPE. Mechanical fixation principle; no energy source. Designed for direct insertion without pilot hole. Non-software device.

Indications for Use

Indicated for soft tissue to bone fixation in shoulder, foot/ankle, knee, hand/wrist, elbow, and hip orthopedic repairs, and for female urinary incontinence (bladder neck suspension) due to urethral hypermobility or intrinsic sphincter deficiency.

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

• CINCH™ Fixation Implant System (K080335)
• TwinFix Ti 2.8mm, 3.5mm and BioRaptor 2.9mm Suture Anchors (K053344)

Submission Summary (Full Text)

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

SEP 2 1 2009

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)

6691870

# General Company Information

Name: Contact:

Tornier, Inc. Howard Schrayer Regulatory Affairs Consultant

Address:

100 Cummings Center Suite 444C Beverly, MA 01915

(978) 232 - 9997 Telephone: (978) 232 – 9998 Fax:

Date Prepared June 22, 2009

## General Device Information

PITON™ Fixation Implant System Product Name:

"Non-degradable soft tissue fixation fastener" Classification: Product code: MBI - Class II

## Predicate Device

| Tornier, Inc. | CINCH™ Fixation Implant System.<br>[510(k) Number K080335] |
|----------------------|-----------------------------------------------------------------------------------|
| Smith & Nephew, Inc. | TwinFix Ti 2.8mm, 3.5mm and BioRaptor 2.9mm<br>Suture Anchors<br>[510(k) K053344] |

{1}------------------------------------------------

## Description

The PITON™ Fixation Implant System includes a 2.8 mm diameter bone anchor and a disposable pre-loaded anchor Inserter. The PITON™ Fixation Implant is designed to secure soft tissue to bone using USP #2 high strength non-absorbable UHMWPE braided suture. The device is designed for inserting the implant directly into bone without a predrilled, punched, or tapped pilot hole.

The PITON™ Anchor configuration is comprised of a curved titanium base and a flared nitinol clip.

## Intended Use (Indications)

The Tornier PITON™ Fixation Implant is intended for fixation of soft tissue to bone.

The PITON™ Implant is intended for use in the following applications:

- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps . Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
- Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Illiotibial Band Tenodesis
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, . Radial Collateral Ligament Reconstruction
- Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral ◆ hypermobility or intrinsic sphincter deficiency
- Hip: Capsular Repair Acetabular Labral Repair ●

## Substantial Equivalence

This submission supports the position that the Tornier PITON™ Fixation Implant System is substantially equivalent to previously cleared devices. including those listed above. A number of predicate devices list the same range of clinical uses.

# Conclusions

Tornier. Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the Tornier PITON™ Fixation Implant System. The materials from which the Tornier device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines.

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of an eagle with outstretched wings.

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

Tornier, Inc. % Mr. Howard Schrayer Regulatory Affairs Consultant 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915

Re: K091870

Trade/Device Name: Tornier, PITON™ Fixation Implant System Regulation Number: 21 CFR 888.3040. Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: June 22, 2009 Received: June 23, 2009

Dear Mr. Schrayer:

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 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.

{3}------------------------------------------------

### Page 2 - Mr. Howard Schrayer

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.

http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely yours,

Mark M Millerson

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

Enclosure

{4}------------------------------------------------

#### INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Tornier, PITON™ Fixation Implant System

Indications For Use:

The Tornier PITON™ Fixation Implant is intended for fixation of soft tissue to bone.

The PITON™ Implant is intended for use in the following applications:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar \ Tendon Repair, Posterior Oblique Ligament Repair. Illiotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament

Reconstruction, Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

Hip: Capsular Repair - Acetabular Labral Repair

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Quta for mxn
(Division Sign of)

Division of Surgic Orthopedic, and Restorative Devices

510(k) Number K091870

4