The Lanx Cervical SA System is a stand-alone cervical fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The Lanx Cervical SA is to be filled with autogenous bone graft material, and is to be used with titanium alloy screws which accompany the implant.

Device Description

The product includes the Lanx Cervical SA PEEK implant models with titanium components for additional fixation. All devices in the Lanx Cervical SA System are made of PEEK-OPTIMA® LT1 per ASTM F2026 and/or Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136. The PEEK components include Tantalum markers per ASTM F560. The Lanx Cervical SA implants have a central cavity to accommodate bone graft, and transverse grooves to improve fixation and stability. Additional fixation and stability is provided by screws and plates which are made from an implant grade titanium alloy (Ti-6Al-4V ELI) meeting the requirements of ASTM F136. The device is available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Cervical SA System is provided non-sterile.

AI/ML Overview

The provided information describes a medical device submission (510(k) summary) for the Lanx Cervical SA Intervertebral Body Fusion System. The core of this document focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving performance of a novel AI/software-as-a-medical-device (SaMD) through a clinical study with detailed acceptance criteria and expert reviews.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of traditional medical device submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Source)	Reported Device Performance (Source)
Mechanical Performance	Per ASTM F2077: Static & Dynamic Compression, Static & Dynamic Compression Shear, Static & Dynamic Torsion	"In all instances, the Lanx Cervical SA System met acceptance criteria and functioned as intended." (Performance Data section)
	Per ASTM F2267: Subsidence	"In all instances, the Lanx Cervical SA System met acceptance criteria and functioned as intended." (Performance Data section)
	ASTM Z8423Z (draft standard): Expulsion testing	"In all instances, the Lanx Cervical SA System met acceptance criteria and functioned as intended." (Performance Data section)
	Flexion/Extension testing	"In all instances, the Lanx Cervical SA System met acceptance criteria and functioned as intended." (Performance Data section)
	Wear debris analysis	"In all instances, the Lanx Cervical SA System met acceptance criteria and functioned as intended." (Performance Data section)

2. Sample size used for the test set and the data provenance

Not Applicable: This document describes mechanical performance testing of an implantable device, not a classification or diagnostic AI/SaMD. The "test set" in this context refers to the physical samples of the device used for mechanical stress tests according to ASTM standards. The specific number of physical units tested is not detailed, but it would adhere to the sample size requirements inherent in each ASTM standard. Data provenance is implicitly from the manufacturing facility where the device was produced for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: Ground truth, in the context of expert consensus, pathology, or outcomes data, is not relevant here. The "ground truth" for mechanical testing is defined by the established parameters and failure modes specified in the ASTM standards. Experts involved would be engineers conducting and interpreting the mechanical tests according to standard protocols, not medical experts establishing diagnostic ground truth.

4. Adjudication method for the test set

Not Applicable: Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert opinions in diagnostic studies. For mechanical testing, the results are quantitative measurements against predefined criteria in the ASTM standards.

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

Not Applicable: This device is a physical intervertebral body fusion system, not an AI or SaMD requiring human reader studies.

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

Not Applicable: This is a physical medical implant, not an algorithm.

7. The type of ground truth used

Mechanical Specifications/Standards: The "ground truth" for this device's performance is against established engineering and mechanical standards (e.g., ASTM F2077, F2267, F136, F2026, F560) which specify material properties, dimensions, and performance under various loads. The device must meet these predefined physical and performance characteristics.

8. The sample size for the training set

Not Applicable: This is not an AI/ML device; therefore, there is no "training set."

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

Not Applicable: As above, no training set. The "ground truth" for mechanical criteria is established by recognized national and international engineering standards (ASTM).

Summary

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DEC 1 6 2011

510(k) SUMMARY

Lanx, Inc's Cervical SA Intervertebral Body Fusion System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Lạnx, Inc. 310 Interlocken Parkway, Suite 120 Broomfield, CO 80021

Contact Person: Michael Funk Phone: 303-443-7500 Facsimile: 303-501-8444 Date Prepared: October 12, 2011

Name of Device and Name/Address of Sponsor

Lanx Cervical SA System Lanx, Inc. 310 Interlocken Parkway, Suite 120 Broomfield, CO 80021

Common or Usual Name

Intervertebral Body Fusion Device

Classification Name

21 CFR § 888.3080, Orthosis, spinal intervertebral fusion

Predicate Devices

Globus Coalition™ (K083389) Medtronic PEEK PREVAIL™ (K094042)

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Intended Use / Indications for Use

Technological Characteristics

This submission is intended to seek clearance for the Lanx Cervical SA Intervertebral Body Fusion System ("Lanx Cervical SA System"). The product includes the Lanx Cervical SA PEEK implant models with titanium components for additional fixation.

All devices in the Lanx Cervical SA System are made of PEEK-OPTIMA® LT1 per ASTM F2026 and/or Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136. The PEEK components include Tantalum markers per ASTM F560. The Lanx Cervical SA implants have a central cavity to accommodate bone graft, and transverse grooves to improve fixation and stability. Additional fixation and stability is provided by screws and plates which are made from an implant grade titanium alloy (Ti-6Al-4V ELI) meeting the requirements of ASTM F136. The device is available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy: The Lanx Cervical SA System is provided non-sterile.

The Lanx Cervical SA System has the same or similar intended use and indications, principles of operation and technological characteristics as predicated devices. Mechanical testing and engineering analysis demonstrated comparable mechanical properties to predicate devices.

Performance Data

Performance testing for comparison of mechanical performance included tests per ASTM F2077 (static and dynamic compression, static and dynamic compression shear, static and dynamic torsion), ASTM F2267 (subsidence), ASTM expulsion testing draft standard Z8423Z (expulsion), Flexion/Extension testing, and wear debris analysis. In all instances, the Lanx Cervical SA System met acceptance criteria and functioned as intended.

Substantial Equivalence

The Lanx Cervical SA System has the same or similar intended uses, indications, technological characteristics, and principles of operation as the previously cleared Globus Coalition™ (K083389) and Medtronic PEEK PREVAIL™ (K094042). The intended use of the subject device and predicate devices contain the same range of levels treated, the same stand-alone indications, and the same implantation methods. The technological characteristics of the subject device are substantially equivalent to the predicate devices, as they all contain a variety of footprints and sizes to accommodate patient anatomy; are available in a range of heights, footprints, and lordotic angles; contain a screw fixation feature to accept at least two bone screws; and provide a mechanism to limit screw back out. Performance data demonstrate that the Lanx Cervical SA System does not raise any issues of safety or effectiveness; hence it is as safe and effective as the predicate devices. Thus, the Lanx Cervical SA System is substantially equivalent to predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Lanx, Inc. % Mr. Michael Funk 310 Interlocken Parkway, Suite 120 Broomfield, Colorado 80021

DEC 1 6 2011

Re: K112388

Trade/Device Name: Lanx Cervical SA Intevertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: November 7, 2011 Received: November 9, 2011

Dear Mr. Funk:

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. Michael Funk

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Erica Keith

Sy Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

Device Name: Lanx Cervical SA Interbody Fusion System

Indications for Use:

The Lanx Cervical SA System is a stand-alone cervical fision device in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These patients should be sketetally mature and have had at least six (6) weeks of non-operative treatment. The Lanx Cervical SA is to be fitted with autogenous bone graft material, and is to be used with titanium alloy screws which accompany the implant.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number___K !!2388

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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.