HAMMERLOC TM TIBIAL FIXATION DEVICE

K103145 · Biomet Sports Medicine · MBI · Feb 9, 2011 · Orthopedic

Device Facts

• Record ID: K103145
• Device Name: HAMMERLOC TM TIBIAL FIXATION DEVICE
• Applicant: Biomet Sports Medicine
• Product Code: MBI · Orthopedic
• Decision Date: Feb 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TunneLoc™ Tibial Fixation Device is intended for soft tissue fixation for the following indications: To provide fixation of soft-tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.

Device Story

TunneLoc™ Tibial Fixation Device is a non-resorbable intratunnel implant for ACL/PCL reconstruction. System includes PEEK implant, inserter instrument, and nitinol guide wire. Surgeon uses inserter to apply/hold graft tension, align, and drive implant into tibial tunnel. Device provides mechanical fixation of soft-tissue graft to bone. Used in arthroscopic surgical procedures by orthopedic surgeons. Benefits include secure graft fixation during reattachment procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing (pullout strength tests) using porcine tibia and bovine tendon models compared to predicate devices.

Technological Characteristics

Non-resorbable PEEK implant; conical shell with blunt wedge tip; cannulated for guide wire insertion. Dimensions: 7-10mm diameter, 30mm length. Mechanical fixation principle. Manual surgical instrumentation.

Indications for Use

Indicated for patients undergoing anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction requiring soft-tissue graft fixation within the tibial tunnel.

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

• Resorbable Interference Screw (K041274)
• Arthrotek Interference Screw (K982497)
• AperFix™ Tibial Implant with Inserter (K083607)
• Intratunnel Tibial Fixation Fastener (K983560)

Submission Summary (Full Text)

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FEB - 9 2011

#### 510(k) Summary

| Preparation Date: | February 9, 2010 |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| Applicant/Sponsor: | Biomet Sports Medicine |
| Contact Person: | Robert R. Friddle<br>Regulatory Affairs Specialist |
| Proprietary Name: | TunneLoc™ Tibial Fixation Device |
| Common Name: | Soft tissue fixation device |
| Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue (21CFR<br>§888.3040) MBI<br>Screw, Fixation, Bone (21CFR §888.3040) HWC |

# Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

| K041274 | Resorbable Interference Screw |
|---------|---------------------------------------|
| K982497 | Arthrotek Interference Screw |
| K083607 | AperFix™ Tibial Implant with Inserter |
| K983560 | Intratunnel Tibial Fixation Fastener |

#### Device Description:

The Biomet Sports Medicine TunneLoc™ Tibial Fixation Device is a non-resorbable intratunnel implant intended to aid in arthroscopic ACL and/or PCL reconstructions. The inserter instrument provides a means to apply and hold tension to the soft tissue, align and drive the PEEK implant. A nitinol quide wire instrument is provided to aid in implant placement. The TunneLoc™ Tibial Fixation Devices provide the surgeon with a means to aid in the management of soft tissue to bone reattachment procedures.

#### Intended Use:

The TunneLoc™ Tibial Fixation Device is intended for soft tissue fixation for the following indications:

To provide fixation of soft-tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.

**Mailing Address:**
P.O. Box 587
Warsaw, IN 46581-0587
Toll Free: 800.348.9500
Office: 574.267.6639
Main Fax: [phone]
[www.biomet.com](http://www.biomet.com)

**Shipping Address:**
56 East Bell Drive
Warsaw, IN 46582

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K103145(²/₂)

## Summary of Technologies:

The TunneLoc™ Implant design includes technological characteristics and indications similar or identical to the predicate devices. The conical shell with blunt wedge tip is similar to the tapered sheath of the predicate Intratunnel Tibial Fixation Fastener (K983560), while the cannulation and insertion over a quide wire are similar to the predicate Gentle Threads™ (K041274). The TunneLoc™ implant is composed of PEEK material like the predicate AperFix™ (K083607). Dimensional characteristics of a 7-10mm diameter range is available in the predicate Gentle Threads™ (K041274) and 30mm length available in all predicates. The TunneLoc™ inserter instrument provides a means to apply and hold tension to the soft tissue graft prior to and during implant insertion similar to the predicate Intratunnel Tibial Fixation Fastener (K983560) and AperFix™ (K083607) Instruments.

## Non-Clinical Testing:

Non-clinical laboratory testing was performed to verify the fixation strength of the TunneLoc™ Tibial Fixation Devices in pullout tests using porcine tibia and bovine tendon test medium as compared to the predicate devices for specific indications for use. The test results indicate that the TunneLoc™ Tibial Fixation Devices provide equivalent pullout strength to the predicate devices and would be functional within their intended use.

## Clinical Testing:

None provided as a basis for substantial equivalence.

All trademarks are the property of Biomet, Inc. except AperFix™ which is a trademark of Cayenne Medical, Inc.

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#### Public Health Service

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

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

FEB 0 9 2011

Re: K103145

Trade/Device Name: TunneLoc™ Tibial Fixation Devices Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: February 4, 2011 Received: February 7, 2011

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 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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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/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.

Ating B. Rata
for

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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## Indications for Use

510(k) Number (if known): كل 103146)5

Device Name: TunneLoc™ Tibial Fixation Device

Indications For Use:

To provide fixation of soft-tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (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 Sign-Off)
for M.Mellors

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103145