Foundation™ Cervical Interbody Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical some with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by pairent history and radies. Foundation™ Cervical implants are used to facilitate interverebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation Cervical implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment. prior to treatment with an intervertebral cage

The Foundation™ Lumbar Interbody Devices are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ Lumbar implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

Device Description

The Foundation™ Interbody Devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the graft donation site. They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis).
The changes to the Foundation™ Interbody Devices cleared in K0733440 and included in this Special 510(k) are:
• Removal of specific surgical approaches for the lumbar devices
• Addition of additional sizes and configurations

AI/ML Overview

The provided text is a 510(k) premarket notification for the "Foundation™ Interbody Devices." It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information (like specific performance acceptance criteria, test set details, expert ground truth adjudication, MRMC studies, and standalone algorithm performance) is not applicable or available in this document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify performance acceptance criteria in terms of clinical outcomes or diagnostic accuracy, as it is a 510(k) submission for a physical medical device (an intervertebral body fusion device). The "performance" being evaluated here is primarily related to mechanical safety, materials, and functional equivalence to existing devices.

Acceptance Criteria (Implied by 510(k))	Reported Device Performance
Material Equivalence	Uses Invibio® PEEK Optima LT1 (ASTM F2026) and Tantalum (ASTM F560), which are standard materials for such implants and claimed to be substantially equivalent to predicate devices.
Design Equivalence	Available in a range of footprints and heights; hollow center for bone graft; superior and inferior surfaces open for bone growth. Changes from predicate (K0733440) include removal of specific surgical approaches for lumbar devices and addition of sizes/configurations. Claimed to be substantially equivalent to predicate devices.
Mechanical Safety/Performance	Finite Element Analysis for bone graft area, contact with endplates, graft volume, and cross-sectional area. Results indicate equivalence to predicate devices.
Intended Use Equivalence	Indications for Use (Cervical and Lumbar DDD with supplemental fixation) are comparable to predicate devices.

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

Test Set Sample Size: Not applicable. No clinical test set involving patients or data for measuring diagnostic/clinical performance was used in this 510(k) summary. The "test set" for this device's evaluation primarily consisted of engineering analyses (Finite Element Analysis) and material characterization.
Data Provenance: Not applicable. The evaluations were non-clinical, involving engineering simulations and material specifications.

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

Not applicable. As no clinical data or diagnostic performance was being evaluated, there was no need for expert ground truth establishment in this context. The "ground truth" for material properties and mechanical performance would be based on established engineering standards and material science data.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method was employed as there was no clinical test set requiring interpretation or consensus on outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This evaluation is for a physical orthopedic implant, not an AI or diagnostic imaging device that would typically undergo MRMC studies.

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

Not applicable. This device is a physical implant and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly based on engineering standards, material specifications (ASTM F2026, ASTM F560), and the established performance and safety profiles of the predicate devices. The device's substantial equivalence is a regulatory judgment based on these data points, not on clinical outcomes or pathology.

8. The Sample Size for the Training Set

Not applicable. No machine learning algorithm or AI was involved, so there was no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there was no training set, no ground truth needed to be established for it.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, arranged in a way that suggests unity and connection. The profiles are black and are set against a white background. Encircling the profiles are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

August 13, 2015

CoreLink, LLC % Mr. J.D. Webb Official Correspondent The Orthomedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K150847

Trade/Device Name: Foundation™ Interbody Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: June 22, 2015 Received: July 27, 2015

Dear Mr. Webb:

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

{1}------------------------------------------------

Page 2 - Mr. J.D. Webb

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/Resourcesfor You/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 vours.

Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

K150847

Device Name

Foundation™ Interbody Devices

Indications for Use (Describe)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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)

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)

{3}------------------------------------------------

510(k) Summary: Foundation™ Interbody Devices

Date Prepared	March 26, 2015
Submitted By	Corelink, LLC7606 Forsyth BlvdClayton, MO 63105888-349-7808 Tele
Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Tele512-692-3699 Faxe-mail: jdwebb@orthomedix.net
Trade Name	Foundation™ Interbody Devices
Common Name	intervertebral body fusion device
Classification Name	intervertebral body fusion device - cervicalintervertebral body fusion device - lumbar
Class	II
Product Code	ODPMAX
CFR Section	21 CFR section 888.3080
Device Panel	Orthopedic
Primary PredicateDevice	Foundation™ Interbody Devices - K073440
Secondary PredicateDevices	Amendia (Verticor) Zeus Cage - K081614DePuy Bengal - K081917Medtronic Verte-Stack Crescent - K094025, K133216Lanx Timberline - K073144Eminent Spine Cottonmouth - K090064Tyber Medical PLIF - K130573
Device Description	The Foundation™ Interbody Devices are implants developed for the substitutionof the classical autogenous bone graft blocks. The cages assist to avoidcomplications related to the graft donation site. They are available in a range offootprints and heights to suit the individual pathology and anatomical conditionsof the patient. The implants have a hollow center to allow placement ofautogenous bone graft. The superior and inferior surfaces are open to promotecontact of the bone graft with the vertebral end plates, allowing bone growth(arthrodesis).The changes to the Foundation™ Interbody Devices cleared in K0733440 andincluded in this Special 510(k) are:• Removal of specific surgical approaches for the lumbar devices• Addition of additional sizes and configurations

{4}------------------------------------------------

Materials	Invibio® PEEK Optima LT1 (ASTM F2026)Tantalum (ASTM F560).
SubstantialEquivalence Claimedto Predicate Devices	The Foundation™ Interbody Devices are substantially equivalent to the predicatedevices in terms of intended use, design, materials used, mechanical safety andperformances.
Indications for Use	Foundation™ Cervical Interbody Devices are indicated for use in skeletallymature patients with degenerative disc disease (DDD) of the cervical spine withaccompanying radicular symptoms at one disc level. DDD is defined asdiscogenic pain with degeneration of the disc confirmed by patient history andradiographic studies. Foundation™ Cervical implants are used to facilitateintervertebral body fusion in the cervical spine and are placed via an anteriorapproach at one disc level (C2-T1) using autograft bone. Foundation™ Cervicalimplants are to be used with supplemental fixation. Patients should have at leastsix (6) weeks of non-operative treatment prior to treatment with an intervertebralcage.The Foundation™ Lumbar Interbody Devices are indicated for intervertebral bodyfusion procedures in skeletally mature patients with degenerative disc disease(DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD isdefined as discogenic pain with degeneration of the disc confirmed by history andradiographic studies. These DDD patients may also have up to Grade Ispondylolisthesis or retrolisthesis at the involved level(s). Foundation™ Lumbarimplants are to be used with autogenous bone graft and supplemental fixation.Patients should have at least six (6) months of non-operative treatment prior totreatment with an intervertebral cage.
Non-clinical TestSummary	The following analyses were conducted:Finite Element Analysis Bone graft area in contact with endplates and graft volume Cross sectional area The results of these evaluations indicate that the Foundation™ Interbody Devicesare equivalent to predicate devices.
Clinical Test Summary	No clinical studies were performed
Conclusions: Non-clinical and Clinical	Corelink, LLC considers the Foundation™ Interbody Devices to be equivalent tothe predicate devices listed above. This conclusion is based upon the devices'similarities in principles of operation, technology, materials and indications foruse

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.