TORNIER, INC., INSITE SUTURE ANCHORS

K083268 · Tornier, Inc. · MAI · Feb 12, 2009 · Orthopedic

Device Facts

• Record ID: K083268
• Device Name: TORNIER, INC., INSITE SUTURE ANCHORS
• Applicant: Tornier, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Feb 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Tornier® Insite™ Bioabsorbable Suture Anchors are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulabral reconstruction Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction, Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair. Illiotibial band tenodesis Hand/Wrist: Scapholunate ligament Radial collateral ligament and Ulnar collateral ligament reconstruction Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

Device Story

Insite™ Suture Anchors are mechanical fasteners used by surgeons to reattach soft tissue to bone. Fabricated from titanium, PLLA absorbable polymer, or acetal polymer; available in 3mm, 5mm, and 6.5mm diameters. Devices are identical to previously cleared Axya Medical suture anchors. Used in orthopedic and pelvic surgical procedures to stabilize tendons and ligaments. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data provided. Substantial equivalence established via design identity to predicate devices and established history of material use.

Technological Characteristics

Materials: Titanium, PLLA absorbable polymer, acetal polymer. Diameters: 3mm, 5mm, 6.5mm. Mechanical fixation device. No energy source, connectivity, or software.

Indications for Use

Indicated for reattachment of soft tissue to bone in shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvic procedures (including bladder neck suspension for female urinary incontinence).

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

• Axya Medical Suture anchors (K003971)
• Axya Medical Suture anchors (K011912)
• Axya Medical Suture anchors (K052491)
• Axya Medical Suture anchors (K051983)
• Axya Medical Suture anchors (K041698)
• Axya Medical Suture anchors (K151250)
• Axya Medical Suture anchors (K060970)

Submission Summary (Full Text)

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# 长083268

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

## General Company Information

- Name: Tornier, Inc. Contact: Howard Schrayer Regulatory Affairs Consultant
FEB 1 2 2009

Address: 100 Cummings Center Suite 444C Beverly, MA 01915

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

- Date Prepared November 4, 2008
### General Device Information

Product Name: Insite™ Suture anchors

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

## Predicate Devices

| Original<br>510(k) Notice | Anchor Material | Nominal Anchor<br>Size (Diameter) | Date Cleared |
|---------------------------|-----------------|-----------------------------------|-----------------|
| K003971 | Titanium | 3mm | March 21, 2001 |
| K011912 | Titanium | 5mm | August 31, 2001 |
| K052491 | Titanium | 6.5mm | October 7, 2005 |
| K051983 | PLLA Polymer | 3mm | August 5, 2005 |
| K041698 | PLLA Polymer | 5mm | October 5, 2004 |
| K151250 | PLLA Polymer | 6.5mm | June 9, 2005 |
| K060970 | Acetal Polymer | 3, 5 and 6.5mm | July 5, 2006 |

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K083268

pg. 2 of 2)

#### Description

The devices described in this 510(k) Notice are exactly the same device as the predicate Axya Medical Suture anchors described in the 510(k) Notices listed above. The various anchors are fabricated from titanium, PLLA absorbable polymer and acetal polymer. They are provided in diameters of 3mm, 5mm and 6.5mm to facilitate the attachment of soft tissue to bone.

No changes have been made to the devices.

#### Intended Use (Indications)

Tornier® Insite™ Bioabsorbable Suture Anchors are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulabral reconstruction

Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction,

Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair. Illiotibial band tenodesis

Hand/Wrist: Scapholunate ligament Radial collateral ligament and Ulnar collateral ligament reconstruction

Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction

Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

#### Substantial Equivalence

This submission supports the position that the Tornier Insite™ Suture anchors are substantially equivalent to the previously cleared Axya Medical devices listed above.

## Conclusions

Tornier. Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same range of clinical applications as the Tornier Insite™ Suture anchors. The materials from which the Tornier devices are fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tornier, Inc. C/o Mr. Howard Schrayer Regulatory Affairs Consultant 100 Cummings Center Beverly, MA 01915

# FEB 1 2 2009

Re: K083268

Trade/Device Name: Insite™ Suture anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: Class II Product Code: MAI, MBI Dated: November 4, 2008 Received: November 18, 2008

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. Isting 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 - Mr. Howard Schrayer

forth in the quality systems (OS) 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 Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474: For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mulhausen

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

510(k) Number (if known): 1083268

Device Name: Insite™ Suture Anchors

Indications For Use:

Tornier® Insite™ Suture Anchors are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulabral reconstruction

Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction

Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis

Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction

Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction

Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milken

(Division Sign-Off) (Division of General, Restorative, and Neurological Devices

510(k) Number