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 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.

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.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the "TARSA-LINK Stand-Alone Wedge Fixation System." It's for a medical device that provides internal bone fixation. Therefore, the "acceptance criteria" and "study" refer to engineering and benchtop tests to demonstrate substantial equivalence to predicate devices, not clinical studies with human participants or AI performance metrics.

Here's the breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance: The device must demonstrate mechanical integrity and function comparable to predicate devices for internal bone fixation.	Finite Element Analysis (FEA) and benchtop testing were presented.
Material Compatibility: Materials used must be implantable grade and meet established standards.	Polyetheretherketone (PEEK) per ASTM F2026 or Titanium (Ti 6Al-4V ELI) per ASTM F136. Tantalum markers per ASTM F560. Titanium screws per ASTM F136.
Design and Function: The design and function of the device must be substantially equivalent to predicate devices.	The TARSA-LINK system is described as substantially equivalent to the predicate systems in terms of design, materials, and indications for use. It is available in various sizes and footprints, with both hollow and C-shape options, and allows for screw placement.
Indications for Use: The device must be suitable for its stated indications: internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot (e.g., Opening wedge osteotomies of Hallux Valgus, Evans lengthening osteotomies, Metatarsal/cuneiform arthrodesis).	The device's intended use matches the stated indications and is compared to predicate devices which also have these indications for use.

2. Sample Size Used for the Test Set and the Data Provenance

This document does not describe a test set in the context of clinical data for AI or human reader performance. Instead, it refers to benchtop testing and Finite Element Analysis (FEA) for a physical medical device. Therefore:

Sample Size: Not specified in terms of number of "samples" in a clinical or AI dataset. For benchtop testing, typically a certain number of devices would be tested, but the exact quantity is not detailed here. For FEA, it's a computational simulation.
Data Provenance: Not applicable in the context of country of origin or retrospective/prospective data as this is a physical device and engineering tests. The data comes from internal testing and analysis performed by the manufacturer, Life Spine.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable to this type of submission. "Ground truth" in this context would refer to the expected mechanical performance, material properties, and design specifications, which are established through engineering standards and internal design verification, not through expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers (e.g., radiologists) when establishing ground truth for diagnostic studies. The evaluation for this device involves engineering tests, not human interpretation of data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This document is for a physical medical implant, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted or mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for evaluating this device's performance is based on:

Engineering Standards: Adherence to material specifications (e.g., ASTM F2026, F136, F560) and mechanical performance criteria derived from established biomechanical principles for bone fixation.
Comparison to Predicate Devices: The reference point for "truth" is the known performance and safety profile of the legally marketed predicate devices. The new device must demonstrate "substantial equivalence" in design, materials, and performance.

8. The sample size for the training set

This is not applicable. This device is not an AI algorithm, so there is no "training set."

9. How the ground truth for the training set was established

This is not applicable. As there is no training set, there is no ground truth established for it.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

The TARSA-LINK Stand-Alone Wedge Fixation System

Submitted By:	Life Spine13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Randy LewisGeneral ManagerLife Spine13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	August 12th, 2016
Trade Name:	TARSA-LINK Stand-Alone Wedge Fixation System
Classification:	HRS, CFR 888.3030, Class IIHWC, CFR 888.3040, Class II
Predicate Device:	Tarsa-Link Wedge Fixation System (K150368)
Additional Predicate:	MaxLock Extreme® System (K113048)MaxLock Extreme® System (K120157)Mini MaxLock Extreme® Plating System (K120157)BIOFOAM® Wedge (K142724)Pro-Link® Wedge System (K141905)

Device Description:

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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.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.