Adjustable Fixation Device

K153186 · Arthrocare Corp. · MBI · Jan 28, 2016 · Orthopedic

Device Facts

• Record ID: K153186
• Device Name: Adjustable Fixation Device
• Applicant: Arthrocare Corp.
• Product Code: MBI · Orthopedic
• Decision Date: Jan 28, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Adjustable Fixation Device is indicated for soft tissue to bone fixation for: - 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

Device Story

Adjustable Fixation Device facilitates soft tissue-to-bone repair; consists of titanium cortical button and graft suspension loop. Device inserted into drilled bone tunnel; loop retains soft tissue graft against bone. Used by surgeons in orthopedic procedures (e.g., ACL/PCL reconstruction). Output is mechanical fixation of graft; provides stability during healing. Benefits patient through secure graft attachment.

Clinical Evidence

No clinical or animal data included. Bench testing only: comparative static and cyclic loading tests against predicates in simulated bone substrate and design verification testing.

Technological Characteristics

Materials: Titanium (Ti-6AL-4V Alloy) cortical button; UHMWPE/polyester suspension loop. Principle: Mechanical graft suspension via cortical button and adjustable loop. Form factor: Implantable fixation fastener. Sterilization: Ethylene Oxide.

Indications for Use

Indicated for patients requiring soft tissue to bone fixation for ACL/PCL repair/reconstruction, patellar bone-tendon-bone grafts, double-tunnel ACL reconstruction, extracapsular repair (MCL, LCL, posterior oblique ligament), iliotibial band tenodesis, patellar tendon repair, VMO advancement, or joint capsule closure.

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

• Biomet ToggleLoc (K083070, K130033)
• N8TIVE ACL Reconstruction System (K133606)

Submission Summary (Full Text)

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

January 28, 2016

ArthroCare Corporation Ms. Katherine Marcaccio Regulatory Affairs Specialist II 15285 Alton Parkway, Number 200 Irvine, California 92618

Re: K153186

Trade/Device Name: Adjustable Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 2, 2015 Received: November 3, 2015

Dear Ms. Marcaccio:

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. 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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the

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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 Industry and Consumer Education at its toll-free 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/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Mark N. Melkerson -S

Mark N. 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)

#### K153186

Device Name Adjustable Fixation Device

Indications for Use (Describe)

The Adjustable Fixation Device is indicated for soft tissue to bone fixation for:

- · 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

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

# ArthroCare® Corporation

Adjustable Fixation Device

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### General Information

| Submitter Name: | ArthroCare Corporation |
|-----------------|-----------------------------------------------------------------------------------------------------|
| Address | 15285 Alton Parkway, Suite 200<br>Irvine, CA 92618 |
| Contact Person: | Katherine Marcaccio<br>Regulatory Affairs Specialist II<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | 2 November 2015 |

#### Device Name

| Proprietary Name: | Adjustable Fixation Device |
|----------------------|----------------------------------------------------|
| Common Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Device Class: | II |
| Product Code: | MBI |
| CFR Section: | 888.3040 |

#### Predicate Devices

The predicate devices for the Adjustable Fixation Device are:

- Biomet ToggleLoc cleared via 510(k) K083070 and subsequently K130033.
- N8TIVE ACL Reconstruction System cleared via 510(k) K133606. ●

#### Description

The Adjustable Fixation Device consists of a graft suspension loop and a titanium cortical button. The suspension loop is threaded through the titanium cortical button to form a graft suspension construction. The device facilitates repair through placement and retention of the soft tissue graft within bone.

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| Characteristics | Biomet ToggleLoc<br>K083070, K130033 | N8TIVE ACL<br>Reconstruction System<br>K133606 | Adjustable<br>Fixation Device<br>Proposed<br>Device |
|----------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Intended Use | Fixation of soft tissue to bone | Same | Same |
| How Supplied | Sterile | Same | Same |
| Sterilization Method | Ethylene Oxide | Same | Same |
| Implant Materials | | | |
| • Cortical Button | Titanium (Ti-6AL-4V Alloy) | Same | Same |
| • Suspension Loop | UHMWPE/Polypropylene/<br>Polyester | UHMWPE/Polyester | Same as<br>N8TIVE |
| • Suture/Suture Tape | Not Applicable | UHMWPE | Not Applicable |
| • Graft Spacer | Not Applicable | PEEK Optima® | Not Applicable |
| • Screw | Not Applicable | Same | Not Applicable |
| • Sheath | Not Applicable | PEEK Optima | Not Applicable |
| • Tether Sutures | Not Applicable | UHMWPE | Not Applicable |
| Method of Insertion | Inserted into drilled<br>hole/tunnel | Same | Same |
| Design Technology | Graft suspension loop with<br>cortical button | Graft Spacer and<br>Suspension Loop with<br>Cortical Button | Same as Biomet<br>ToggleLoc |
| Implant<br>Size/Dimensions | | | |
| • Cortical Button | 13.2mm x 2.0mm x 1.8mm | 12.1mm x 3.9mm x<br>1.8mm (Femoral<br>Implant)<br><br>18mm x 11.5mm 6.1mm<br>(Tibial Implant) | Same as<br>N8TIVE<br>Femoral<br>Implant |
| • Suspension Loop | Adjustable | Same | Same |
| • Graft Spacer | Not Applicable | 23mm x 6mm x 6mm | Not applicable |
| • Screw | Not Applicable | Range of 29 to 36mm<br>length, 8mm diameter | Not Applicable |
| • Sheath | Not Applicable | Range of 33 to 40mm<br>length | Not Applicable |

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## Intended Use

The Adjustable Fixation Device is indicated for soft tissue to bone fixation for:

- 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

### Non-Clinical Data

Bench testing was conducted as follows:

- l Comparative testing of the proposed and predicate devices in which the proposed and predicate devices were inserted into a simulated human bone substrate and subjected to cyclic and static loading.
- I Design Verification testing to demonstrate conformance to design and performance specifications.

All test results confirm that Adjustable Fixation Device is substantially equivalent to the predicate devices. Additionally, the test results confirm that the devices meet their design, performance, and safety specifications.

### Clinical Data

No clinical or animal data are included in this submission.

#### Summary

All testing demonstrates that the Adjustable Fixation Device performs as intended and has acceptable mechanical properties when used in accordance with the device labeling.

As the intended use, operating principle, materials, and technological characteristics are comparable to the predicate devices, ArthroCare believes the Adjustable Fixation Device is substantially equivalent to the predicate devices. The minor differences between the ArthroCare devices and their predicate devices do not raise any new questions of safety or effectiveness.