The Ancora LLC Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. The device must be used with supplemental fixation (i.e., lateral plating or pedicle screw systems), which is in addition to the integrated locking plates provided in the system. When used with the integrated locking plates, it is indicated to be used at one level from L2-L5. When used without the integrated locking plates, it is indicated to be used at one or two contiguous levels, from L2-S1. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone.

Device Description

The Ancora system consists of different footprints and heights to provide options that correlate best to an individual's anatomy and pathology. The system offers optional integrated locking plates with corresponding locking pins. Implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F136 and PEEK Optima LT1 per ASTM F2026 with tantalum markers per ASTM F560. Supplemental anterior and/or posterior fixation is intended for use with the device to ensure stability of the spine.

The purpose of this submission is to add implant configurations to the Ancora LLC line of implants, and modify the indications for use so the locking plates are optional fixation devices. Surgical Instruments are also available for use with the system.

AI/ML Overview

This document describes the Ancora LLC Interbody Fusion Device, a medical device designed to facilitate spinal fusion. The information provided outlines its intended use, technical specifications, and the testing conducted to demonstrate its substantial equivalence to previously approved devices.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Description	Reported Device Performance (from Performance Data section)
Static Axial Compression	Completed following ASTM F2077. Indicated substantial equivalence to predicate devices and adequacy for intended use.
Dynamic Axial Compression	Completed following ASTM F2077. Indicated substantial equivalence to predicate devices and adequacy for intended use.
Static Compression Shear	Completed following ASTM F2077. Indicated substantial equivalence to predicate devices and adequacy for intended use.
Dynamic Compression Shear	Completed following ASTM F2077. Indicated substantial equivalence to predicate devices and adequacy for intended use.
Expulsion Testing	Conducted following a recognized protocol to allow comparison evaluation of intervertebral body fusion device assemblies, and characterize their resistance to expulsion. Indicated substantial equivalence to predicate devices and adequacy for intended use.

Note: The document states that the pre-clinical testing "indicated that the Ancora LLC Interbody Fusion Device is substantially equivalent to the predicate devices and is adequate for the intended use." Specific quantitative performance metrics (e.g., measured load capacities, displacement values) are not provided in this summary, only that the testing was performed according to relevant standards and the results met the criteria for substantial equivalence.

Sample Size Used for the Test Set and Data Provenance:
The provided document describes pre-clinical bench testing (static and dynamic axial compression, static and dynamic compression shear, and expulsion testing) of the device. This type of testing typically involves physical samples of the device itself rather than patient data. Therefore, the concepts of "sample size used for the test set" in terms of patients and "data provenance" (country of origin, retrospective/prospective) are not applicable to this pre-clinical performance data. The testing was conducted on device specimens in a laboratory setting.
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. As this is pre-clinical bench testing, there is no "ground truth" established by human experts in the way it would be for clinical data interpretation (e.g., radiologists assessing images). The acceptance criteria for mechanical performance tests are defined by ASTM standards and scientific principles, not expert consensus on individual cases.
Adjudication Method for the Test Set:
Not applicable. Since expert human assessors are not involved in establishing ground truth for mechanical bench testing, an adjudication method is not relevant. The results are physical measurements compared against predefined engineering standards.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document does not describe any MRMC comparative effectiveness study, as the filing pertains to pre-clinical bench testing of a spinal fusion device, not an AI or imaging diagnostic tool.
Standalone Performance Study:
Yes, implicitly. The "Performance Data" section describes pre-clinical bench testing of the Ancora LLC Interbody Fusion Device itself. This testing evaluates the device's mechanical properties and resistance to expulsion in isolation, without human interaction during its function. This is a standalone evaluation of the device's physical performance.
Type of Ground Truth Used:
For the mechanical performance testing, the "ground truth" is defined by the acceptance criteria established by engineering standards (ASTM F2077) and a "recognized protocol" for expulsion testing. The device's performance measurements are compared against these established specifications to determine if they meet the requirements for substantial equivalence.
Sample Size for the Training Set:
Not applicable. This document describes the pre-clinical bench testing of a physical medical device. It does not involve AI algorithms, machine learning models, or the use of training data sets in the computational sense.
How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for the type of device and testing described, the method for establishing its ground truth is irrelevant.

Summary

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

February 26, 2015

Frontier Medical Devices, Incorporated % Rich Jansen, Pharm.D. Silver Pine Consulting, LLC 11821 Bramble Cove Drive Ft. Myers, Florida 33905

Re: K143228

Trade/Device Name: Ancora LLC Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: November 28, 2014 Received: December 01, 2014

Dear Dr. Jansen:

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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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 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) K143228

Device Name Ancora LLC Interbody Fusion Device

Indications for Use (Describe)

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)

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FOR FDA USE ONLY

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

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510(k) SUMMARY

Frontier Medical's Ancora Lateral Locking Cage (LLC) Interbody Fusion Device

Date:	February 24, 2015
Submitter:	Frontier Medical, LLC512 Fourth StreetGwinn, MI 49841906-232-1200
Contact Person:	Rich Jansen, Pharm. D.Silver Pine Consulting612-281-5505
Name:	Ancora LLC Interbody Fusion Device
Product Class:	Class II
Classification:	21 CFR §888.3080 (Intervertebral body fusion device)
Product Codes:	MAX, OVD
Panel Code:	87
Common or Usual Name:	Intervertebral body fusion device

Predicate Devices

The Ancora LLC was shown to be substantially equivalent to legally marketed predicate devices. The primary predicate device is the Ancora LLC (K112700). Additional predicate devices are the CoRoent XL-F Device (K140479), and the BAK Device (P950002).

Device Description

Indications for Use

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plates, it is indicated to be used at one or two contiguous levels, from L2-S1. Patients should have received 6 months of non-operative treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

Performance Data

Static and dynamic axial compression and static and dynamic compression shear were completed following ASTM F2077. Expulsion testing was conducted following a recognized protocol to allow comparison evaluation of intervertebral body fusion device assemblies, and characterize their resistance to expulsion. The above pre-clinical testing performed on the Ancora LLC Interbody Fusion Device indicated that the Ancora LLC Interbody Fusion Device is substantially equivalent to the predicate devices and is adequate for the intended use.

Technological Characteristics

The Ancora LLC Interbody Fusion Device and predicate devices have the same intended use, to provide mechanical stability in the lumbar disc space to facilitate biologic fusion. The indications for use of the Ancora LLC Interbody Fusion Device are the same as the predicate devices. Moreover, the device is very similar in its size to the predicate devices. The materials used are also the same as in the predicate device. There are no significant differences in technological characteristics compared to the predicate devices, and the minor differences that do exist do not raise any new types of safety or efficacy issues. Furthermore, bench testing demonstrates that these differences do not adversely impact device performance.

Conclusion

Frontier Medical Devices concludes that the Ancora LLC Interbody Fusion Device is substantially equivalent to the predicate devices.

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.