The PRO-LINK Wedge and screws are 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 PRO-LINK Wedge 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. It is fabricated and manufactured from Polyetheretherketone (PEEK-OPTIMA LT1) with tantalum markers and titanium pins (Ti 6A1-4V ELI). The implant is hollow to permit packing with autogenous bone graft to help fusion. The implant has two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) through the wedge to provide internal fixation. The implant also has one central threaded hole to permit the insertion of a titanium lock plate (Ti 6Al-4V ELI) to prevent screw back out.

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

AI/ML Overview

This document describes the Pro-Link Wedge System, a medical device for internal bone fixation in the ankle and foot. However, the provided text does not contain the information requested in points 1 through 9 regarding acceptance criteria and a study proving the device meets those criteria.

The document is a 510(k) premarket notification summary submitted to the FDA. It details the device's intended use, materials, and technological characteristics, and presents performance data based on mechanical testing and Finite Element Analysis to demonstrate substantial equivalency to predicate devices. This type of submission focuses on showing that a new device is as safe and effective as a legally marketed predicate device, rather than providing a detailed study against specific acceptance criteria for a novel AI or diagnostic system.

Therefore, I cannot fulfill your request for the specific points because the information is not present in the provided text. The text primarily addresses regulatory submission requirements for a bone fixation system, not a study evaluating performance against acceptance criteria typically associated with AI or diagnostic devices.

Summary

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

September 26, 2014

Life Spine, Inc. Mr. Randy Lewis General Manager 2401 West Hassell Road, Suite 1535 Hoffman Estates, Illinois 60169

Re: K141905

Trade/Device Name: Pro-Link Wedge 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: August 04, 2014 Received: August 05, 2014

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 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 - Mr. Randy Lewis

forth in the quality systems (OS) 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/Resourcesfor You/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Lori A. Wiggins -S

for

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K141905

Device Name The Pro-Link Wedge System

Indications for Use (Describe)

The PRO-LINK Wedge and screws are 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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Pro-Link Wedge System

Submitted By:	Life Spine2401 W. Hassell Road, Suite 1535Hoffman Estates, IL 60169Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Randy LewisGeneral ManagerLife Spine2401 W. Hassell Road, Suite 1535Hoffman Estates, IL 60169Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	July 11th, 2014
Trade Name:	Pro-Link Wedge System
Classification:	HWC, CFR 888.3040, Class IIHRS, CFR 888.3030, Class II
Predicate Device:	BioFoam Wedge System (K093950)OrthoHelix Maxlock Extreme System (K113048)

Device Description:

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Intended Use of the Device:

The PRO-LINK Wedge and screws are 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 Pro-Link Wedge System is substantially equivalent to the predicate systems in terms of design, materials, and indications for use.

Material:

The PRO-LINK Wedge System is manufactured from implantable grade PEEK-Optima per ASTM F2026, incorporates tantalum markers per ASTM F560, and implantable grade titanium (Ti 6Al-4V ELI) per ASTM F136.

Performance Data:

Static and Dynamic Compression and Torsion testing in accordance with ASTM F2077, in addition to Finite Element Analysis, was presented to demonstrate the substantial equivalency of the Pro-Link Wedge System.

Conclusion:

The Pro-Link Wedge 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.