NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS

K122437 · Biomet Sports Medicine · MBI · Oct 18, 2013 · Orthopedic

Device Facts

• Record ID: K122437
• Device Name: NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS
• Applicant: Biomet Sports Medicine
• Product Code: MBI · Orthopedic
• Decision Date: Oct 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Soft tissue fixation to bone, specifically during ligament reconstructive procedures.

Device Story

WasherLoc™ and No-Profile Screw and Washer Systems consist of titanium alloy (Ti-6Al-4V) screws and washers used for soft tissue fixation to bone during ligament reconstructive procedures. The system includes 4.5mm and 6.0mm diameter screws (30mm-70mm lengths) and 14mm, 16mm, and 18mm diameter washers (with or without spikes). The device is used by surgeons in clinical settings. This submission updates the labeling to designate the devices as MR Conditional. The device functions as a mechanical fastener to secure soft tissue to bone.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on non-clinical MR evaluation.

Technological Characteristics

Materials: Titanium Alloy (Ti-6Al-4V). Form factor: Screws (4.5mm/6.0mm diameter, 30-70mm length) and washers (14mm/16mm/18mm diameter, with/without spikes). Principle: Mechanical bone fixation fastener. MR status: MR Conditional.

Indications for Use

Indicated for soft tissue fixation to bone during ligament reconstructive procedures.

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

• WasherLoc™, Ligament Washer, Lo-Profile™, Heckman™, and Channel Ligament Screw Systems - Biomet Sports Medicine (K981967)
• Cancellous Fixation Screw & Washer - Concept Inc. (K871037)

Submission Summary (Full Text)

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## 510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

| Submitter Information | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Name | Biomet Sports Medicine | |
| Address | 56 East Bell Drive<br>P.O. Box 587<br>Warsaw, IN 46581-0857 | |
| Phone number | [phone] | |
| Fax number | [phone] | |
| Establishment | 1825034 | |
| Registration Number | | |
| Name of contact person | Elizabeth Wray / Senior Regulatory Affairs Specialist | |
| Date prepared | August 7, 2012 | |
| Name of device | | |
| Trade or proprietary<br>name | WasherLoc™ and No-Profile Screw and Washer Systems | |
| Common or usual<br>name | Soft Tissue Fixation Devices | |
| Classification name | Fastener, fixation, nondegradable, soft tissue and smooth or<br>threaded metallic bone fixation fastener | |
| Classification panel | Orthopedic | |
| Regulation | 888.3040 | |
| Product Code(s) | MBI or HWC | |
| Legally marketed device(s)<br>to which equivalence is<br>claimed | WasherLoc™, Ligament Washer, Lo-Profile™, Heckman™, and<br>Channel Ligament Screw Systems - Biomet Sports Medicine<br>K981967<br>Cancellous Fixation Screw & Washer - Concept Inc., K871037 | |
| Reason for 510(k)<br>submission | Addition of magnetic resonance (MR) compatibility language to<br>the product labeling. | |
| Device description | The WasherLoc™ and No-Profile Screw and Washer Systems<br>include titanium alloy (Ti-6Al-4V) screws and washers in various<br>lengths and sizes. Both 4.5mm and 6.0mm diameter screws in<br>lengths from 30mm to 70mm are available, with washer sizes in<br>14mm, 16mm, and 18mm diameters with and without spikes. | |
| Intended use of the device | Soft Tissue Fixation | |
| Indications for use | Soft tissue fixation to bone, specifically during ligament<br>reconstructive procedures. | |
| Summary of the technological characteristics of the device compared to the predicate | | |
| Characteristic | WasherLoc™ and No-Profile<br>Screw and Washer Systems<br>(Modified Device) | Predicate - WasherLoc™,<br>Ligament Washer, Lo-Profile™,<br>Heckman™, and Channel<br>Ligament Screw Systems<br>(K981967) |
| Material | Titanium Alloy (Ti-6Al-4V) | K981967 |
| Magnetic Resonance<br>Information | MR Conditional | Not evaluated |
| PERFORMANCE DATA | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF<br>SUBSTANTIAL EQUIVALENCE | | |
| Summary of Technologies | | |
| The WasherLoc™ and No-Profile Screw and Washer Systems have been evaluated for the effects<br>of magnetic resonance (MR) and deemed MR Conditional. | | |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL<br>EQUIVALENCE AND/OR OF CLINICAL INFORMATION | | |
| None provided as a basis for substantial equivalence. | | |

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### CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

·

The results of the MR evaluation indicated that the devices are MR Conditional.

All trademarks are the property of Biomet, Inc.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like shapes, representing the department's mission related to health and human well-being.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Flealth Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

October 18, 2013

Biomet Sports Medicine Ms. Elizabeth Wray Senior Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581

Rc: K122437

Trade/Device Name: WasherLoc" and No-Profile Screw and Washer Systems Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: October 8, 2013 Received: October 9, 2013

Dear Ms. Wray:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 (2 l 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

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Page 2 - Ms. Elizabeth Wray

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/gefault.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.

Sincercly yours,

Mark N: Melkerson -S

Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K122437

Device Name: WasherLoc™ and No-Profile Screw and Washer Systems

Indications For Use:

Soft tissue fixation to bone, specifically during ligament reconstructive procedures.

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)

**Casey L. Hanley, Ph.D.**
Division of Orthopedic Devices

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