TOGGLELOC SYSTEM

K083070 · Biomet Sports Medicine · MBI · Dec 16, 2008 · Orthopedic

Device Facts

• Record ID: K083070
• Device Name: TOGGLELOC SYSTEM
• Applicant: Biomet Sports Medicine
• Product Code: MBI · Orthopedic
• Decision Date: Dec 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ToggleLoc™ System Devices are intended for soft tissue to bone fixation for the following indications: Shoulder: Bankart lesion repair, SLAP lesion repairs Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps Tenodesis Foot and Ankle: Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair, Ankle Syndesmosis fixation (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures (only for ToggleLoc™ with Tophat) Elbow; Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment Knee: ACL/PCLrepair / reconstruction, ACL/PCL patellar bone-tendon-bone grafts, Double-Tunnel ACL reconstruction, Extracapsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule dosure Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction Hip: Acetabular labral repair

Device Story

ToggleLoc™ System consists of toggle buttons and Tophat suture buttons preloaded with sutures/fiber constructs; designed for soft tissue-to-bone fixation. Surgeon uses device in clinical settings to secure soft tissue to bone during orthopedic repairs (e.g., ACL/PCL reconstruction, rotator cuff repair, syndesmosis fixation). System provides mechanical fixation via button-suture construct; facilitates surgical workflow by being preloaded. Output is physical fixation of tissue to bone, aiding healing and structural stability. No electronic or software components.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing.

Technological Characteristics

Soft tissue fixation system comprising toggle buttons and Tophat suture buttons; preloaded with sutures/fiber constructs. Metallic bone fixation fastener. Class II device.

Indications for Use

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

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

• TightRope™ Syndesmosis Device (K043248)
• Sleeve and Button Soft Tissue Devices (K071704)
• Titanium Toggle Buttons (K033838)

Submission Summary (Full Text)

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K083070

Image /page/0/Picture/1 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and connected to each other. There is a registered trademark symbol to the right of the letter "T". The word is in black and the background is white.

## 510(k) Summary

DEC 1 6 2008

Preparation Date: December 4, 2008

Applicant/Sponsor: Biomet Sports Medicine

Contact Person: Robert Friddle

Proprietary Name: ToggleLoc™ System

Common Name: Soft tissue anchor

Classification Name: Fastener, fixation, nondegradable, soft tissue (888.3040)

## Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

TightRope™ Syndesmosis Device - K043248 (Arthrex) Sleeve and Button Soft Tissue Devices - K071704 (Biomet Sports Medicine) Titanium Toggle Buttons - K033838 (Biomet Sports Medicine, formerly known as Arthrotek, Inc.)

Device Description: The ToggleLoc™ System contains toggle buttons and a Tophat suture button preloaded with sutures and/or fiber constructs. The suture button has multiple eyelets for attachment of fiber constructs and/or sutures. The fiber constructs and/or sutures are preloaded for the convenience of the surgeon for soft tissue attachment.

Intended Use: The ToggleLoc™ System Devices are intended for soft tissue to bone fixation for the following indications:

Shoulder: Bankart lesion repairs Acromio-clavicular repair, Capsular shift/capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps Tenodesis

Foot and Ankle: Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair, Ankle Syndesmosis fixation (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures (only for ToggleLoc™ with Tophat)

Elbow: Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment

Knee: ACL/PCL repair / reconstruction, ACL/PCL patellar bone-tendon-bone grafts, Double-Tunnel ACL reconstruction, Extracapsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure

Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx. Volar plate reconstruction

Hip: Acetabular labral repair

Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800,348,9500 Office: 574.267.6539 Main Fax: [phone] www.blomet.com

Shipping Address: 56 East Bell Drive Warsaw. IN 46582

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Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the ToggleLoc™ System devices are similar or identical to the predicate device or other previously cleared devices.

Non-Clinical Testing: Non-dinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc. except TightRope™ which is a trademark of Arthrex.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 6 2008

Biomet Sports Medicine % Mr. Robert Friddle 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587

Re: K083070

Trade/Device Name: ToggleLocTM System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI, JDR Dated: October 13, 2008 Received: October 15, 2008

Dear Mr. Friddle:

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 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 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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# Page 2 - Mr. Robert Friddle

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 Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events, (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Milherson

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): KD83070

Device Name: _ ToggleLoc™ System

Indications for Use:

The ToggleLoc™ System Devices are intended for soft tissue to bone fixation for the following indications:

Shoulder: Bankart lesion repair, SLAP lesion repairs Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps Tenodesis

Foot and Ankle: Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair, Ankle Syndesmosis fixation (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures (only for ToggleLoc™ with Tophat)

Elbow; Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment

Knee: ACL/PCLrepair / reconstruction, ACL/PCL patellar bone-tendon-bone grafts, Double-Tunnel ACL reconstruction, Extracapsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule dosure

Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction

Hip: Acetabular labral repair

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

Over-The-Counter Use NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General, Restorative, and Neurological Devices

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**510(k) Number** L083070