Tarsa-Link Stand-Alone Wedge Fixation System

K161037 · Life Spine, Inc. · HRS · Aug 15, 2016 · Orthopedic

Device Facts

• Record ID: K161037
• Device Name: Tarsa-Link Stand-Alone Wedge Fixation System
• Applicant: Life Spine, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Aug 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TARSA-LINK Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as: Opening wedge osteotomies of Hallux Valgus Evans lengthening osteotomies Metatarsal/cuneiform arthrodesis

Device Story

TARSA-LINK Stand-Alone Wedge Fixation System provides internal bone fixation for ankle and foot procedures; includes wedge implants in various sizes/footprints. Implants are hollow for autogenous bone graft packing; C-shape version available for procedures not requiring graft. Features two pockets for titanium bone screws to provide fixation; available with midline or offset screw configurations. Used by surgeons in clinical settings for bone fractures, fusions, or osteotomies. Benefits patient by stabilizing bone segments to facilitate fusion and healing.

Clinical Evidence

Bench testing only. Evidence includes Finite Element Analysis, engineering rationale, and benchtop testing to demonstrate substantial equivalence.

Technological Characteristics

Materials: PEEK (ASTM F2026) or Titanium (Ti 6Al-4V ELI, ASTM F136). Includes tantalum markers (ASTM F560) and titanium pins/screws (Ti 6Al-4V ELI, ASTM F136). Form factor: Wedge-shaped implant with screw pockets. Single-use. No software or energy source.

Indications for Use

Indicated for patients requiring internal bone fixation for fractures, fusions, or osteotomies in the ankle and foot, including Hallux Valgus opening wedge osteotomies, Evans lengthening osteotomies, and metatarsal/cuneiform arthrodesis.

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

• Tarsa-Link Wedge Fixation System (K150368)
• MaxLock Extreme® System (K113048)
• MaxLock Extreme® System (K120157)
• Mini MaxLock Extreme® Plating System (K120157)
• BIOFOAM® Wedge (K142724)
• Pro-Link® Wedge System (K141905)

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

August 15, 2016

Life Spine Incorporated Mr. Randy Lewis General Manager 13951 South Quality Drive Huntley, Illinois 60142

Re: K161037

Trade/Device Name: Tarsa-Link Stand-Alone Wedge Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: July 15, 2016 Received: July 18, 2016

Dear Mr. Lewis:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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" (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 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,

# 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

ions for Use

510(k) Number (if known) K161037

#### Device Name

TARSA-LINK Stand-Alone Wedge Fixation System

Indications for Use (Describe)

The TARSA-LINK Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:

· Opening wedge osteotomies of Hallux Valgus

· Evans lengthening osteotomies

· Metatarsal/cuneiform arthrodesis

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

| <div> <span> <svg height="16" width="16"> <path d="M2 2h12v12H2z" fill="none" stroke="currentColor" stroke-width="2"></path> <path d="M4 8l4 4 6-6" fill="none" stroke="currentColor" stroke-width="2"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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## 510(k) Summary

#### The TARSA-LINK Stand-Alone Wedge Fixation System

| Submitted By: | Life Spine<br>13951 S. Quality Drive<br>Huntley, IL 60142<br>Telephone: [phone]<br>Fax: [phone] |
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| 510(k) Contact: | Randy Lewis<br>General Manager<br>Life Spine<br>13951 S. Quality Drive<br>Huntley, IL 60142<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | August 12th, 2016 |
| Trade Name: | TARSA-LINK Stand-Alone Wedge Fixation System |
| Classification: | HRS, CFR 888.3030, Class II<br>HWC, CFR 888.3040, Class II |
| Predicate Device: | Tarsa-Link Wedge Fixation System (K150368) |
| Additional Predicate: | MaxLock Extreme® System (K113048)<br>MaxLock Extreme® System (K120157)<br>Mini MaxLock Extreme® Plating System (K120157)<br>BIOFOAM® Wedge (K142724)<br>Pro-Link® Wedge System (K141905) |

### Device Description:

The TARSA-LINK Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot. The implant is available in a range of sizes and footprints to suit the individual anatomical conditions of the patient. Additionally, the wedge is fabricated and manufactured with two different materials: 1) Polyetheretherketone (PEEK) with tantalum markers and titanium pins (Ti 6Al-4V ELI). 2) Titanium (Ti 6Al-4V ELI).

The implant is hollow to permit packing with autogenous bone graft to help fusion. A C-Shape footprint of the device is also offered for use in procedures where bone graft is not required. The implant has two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) through the wedge to provide internal fixation. Devices are offered with either midline or offset screw pockets.

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All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the TARSA-LINK Stand-Alone Wedge Fixation System components with components from any other system or manufacturer. The TARSA-LINK Stand-Alone Wedge Fixation System components should never be reused under any circumstances.

# Intended Use of the Device:

The TARSA-LINK Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:

- Opening wedge osteotomies of Hallux Valgus ●
- Evans lengthening osteotomies ●
- Metatarsal/cuneiform arthrodesis

# Technological Characteristics:

The TARSA-LINK Stand-Alone Wedge Fixation System is substantially equivalent to the predicate systems in terms of design, materials, and indications for use.

# Material:

The TARSA-LINK Stand-Alone Wedge Fixation System is manufactured from either implantable grade Polyetheretherketone (PEEK) per ASTM F2026 or Titanium (Ti 6Al-4V ELI) per ASTM F136. The device incorporates tantalum markers per ASTM F560, and implantable grade titanium (Ti 6Al-4V ELI) per ASTM F136.

# Performance Data:

Finite Element Analysis, engineering rationale and benchtop testing was presented to demonstrate the substantial equivalency of the TARSA-LINK Stand-Alone Wedge Fixation System

# Conclusion:

The TARSA-LINK Stand-Alone Wedge Fixation System was shown to be substantially equivalent to the previously cleared devices in indications for use, design, function, and materials used.