When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion System is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Anterior Cervical Plate System.

When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Lanx Fusion System is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Lanx Spinal Fixation System. The Lanx SA standalone interbody implants, when implanted via an anterior approach and used with the integrated fixation screws, do not require use of supplemental fixation. The Lanx Lateral-SA implants are to be used with supplemental fixation.

When used as vertebral body replacement, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e. T1- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.

Device Description

The Lanx Fusion System devices are made of PEEK (OPTIMA®) per ASTM F2026 and/or Titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The PEEK components include Tantalum markers per ASTM F560. The implant has a hollowed out area to accommodate bone graft, and transverse grooves to improve fixation and stability. Additional fixation and stability is provided by screws which are made from an implant grade titanium alloy (Ti-6AI-4V ELI) meeting the requirements of ASTM F136. It is available in a variety of different sizes to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The purpose of this submission is to expand the available plate options for the Lanx Lateral-SA implants. The Lanx Fusion System is provided non-sterile.

AI/ML Overview

Here's an analysis of the provided text regarding the Lanx Fusion System, focusing on acceptance criteria and study details.

Based on the provided {0}-{5} text, this is a 510(k) summary for a spinal implant (Lanx Fusion System) seeking FDA clearance. The document describes the device, its intended use, and claims substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria or a study that "proves the device meets the acceptance criteria" in the way a clinical study for an AI/CADe device would.

Instead, the "Performance Data" section specifically refers to bench testing and engineering analysis performed to demonstrate substantial equivalence for a medical device implant. It evaluates mechanical properties of the implant, not diagnostic accuracy in interpreting medical images or data.

Therefore, many of your requested points regarding AI/CADe system evaluation metrics (such as test set sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this type of device submission.

Here's a breakdown of the requested information based on the provided text, indicating where information is present and where it is not applicable or not provided:

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Compliance with ASTM F2077 (static/dynamic compression, static compression shear, static torsion)	"In all instances, the modified device met or exceeded predicate device performance, functioned as intended..." (Implies compliance with F2077). Specific numerical performance values are not provided nor are the specific acceptance thresholds for these tests in this summary. Instead, it states the device met or exceeded the predicate device's performance.
Compliance with ASTM draft expulsion testing standard Z8423Z (expulsion tests)	"...met or exceeded predicate device performance, functioned as intended..." (Implies compliance with Z8423Z). Specific numerical performance values are not provided.
Compliance with ASTM F1877 (wear debris)	"...met or exceeded predicate device performance, functioned as intended..." (Implies compliance with F1877). Specific numerical performance values are not provided.
Substantial Equivalence to predicate device (K123767)	"The modified Lanx Fusion System implants... have the same intended use, indications, technological characteristics, and principles of operation as the previously cleared Lanx Fusion System devices (K123767). The minor differences... do not raise any new issues of safety or effectiveness. Performance data presented also demonstrated comparable properties..."

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This document describes mechanical bench testing of an implant, not a clinical study involving a "test set" of patient data in the typical sense. The "performance testing" refers to physical tests on the device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided. Ground truth by medical experts is relevant for diagnostic devices or AI systems. This is an implant, and its performance is evaluated physically against engineering standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. Adjudication methods are used in clinical studies to resolve discrepancies in expert interpretations. This is not a clinical study.
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 / Not Provided. MRMC studies are specifically for evaluating diagnostic performance, often for AI/CADe systems. This device is an implant for spinal fusion and replacement, not a diagnostic tool or an AI system.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable / Not Provided. This concept applies to AI algorithms. The Lanx Fusion System is a physical medical implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this device's performance would be the established engineering standards (ASTM F2077, ASTM draft Z8423Z, ASTM F1877) and the performance characteristics of its predicate device.
The sample size for the training set
- Not Applicable / Not Provided. This is a physical implant, not an AI system that requires a "training set."
How the ground truth for the training set was established
- Not Applicable / Not Provided. As above, this is not an AI system. "Ground truth" for its design and manufacturing would come from engineering specifications, material properties, and regulatory standards.

Summary

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

510(k) SUMMARY Lanx Fusion System

JUL 1 2 2013

Submitter's Information

Name and Address:	Lanx, Inc.310 Interlocken Parkway, Suite 120Broomfield, CO 80021(303) 501-8411
Contact Person:	Alan Burkholder
Date Prepared:	July 10, 2013
Device Identification
Proprietary Name:	Lanx Fusion System
Common Name:	Vertebral Body Replacement/Intervertebral Body FusionDevice with Integrated Fixation, Lumbar
Classification:	Orthosis, spinal intervertebral fusion and/or Spinalintervertebral body fixation orthosis (per 21 CFR § 888.3080

and/or § 888.3060)

Predicate Device Information

K123767 Lanx Fusion System

Intended Use / Indications for Use

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

have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Lanx Fusion System is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Lanx Spinal Fixation System. The Lanx SA standalone interbody implants, when implanted via an anterior approach and used with the integrated fixation screws, do not require use of supplemental fixation. The Lanx Lateral-SA implants are to be used with supplemental fixation.

Device Description & Technological Characteristics

Performance Data

Performance testing and engineering analysis was performed to demonstrate substantial equivalence to the predicate device. Performance testing included tests per ASTM F2077 (static and dynamic compression, static compression shear, static torsion), ASTM draft expulsion testing standard Z8423Z (expulsion tests), and ASTM F1877 (wear debris). In all instances, the modified device met or exceeded predicate device performance, functioned as intended and therefore demonstrated substantial equivalence to the predicate device.

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

Substantial Equivalence

The modified Lanx Fusion System implants included in the product line extension have the same intended use, indications, technological characteristics, and principles of operation as the previously cleared Lanx Fusion System devices (K123767). The minor differences in the new components do not raise any new issues of safety or effectiveness. Performance data presented also demonstrated comparable properties to the previously cleared Lanx Fusion system devices. Thus, the modified device has been shown to be substantially equivalent to the predicate device.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three legs. 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 Center - WO66-G609 Silver Spring, MD 20993-0002

July 12, 2013

Lanx, Incorporated % Mr. Alan Burkholder Director of Engineering 310 Interlocken Parkway, Suite 120 Broomfield, Colorado 80021

Re: K131547

Trade/Device Name: Lanx Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MQP, ODP, MAX Date: June 13, 2013 Received: June 14, 2013

Dear Mr. Burkholder:

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

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

Page 2 - Mr. Alan Burkholder

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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). plcase 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/MedicalDcvices/ResourcesforYou/Industry/default.htm.

Sincercly yours.

Erin I. Keith

For

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

Enclosure

{5}------------------------------------------------

Indications for Use Statement

K131547 510(k) Number (if known):

Device Name: Lanx Fusion System

Indications for Use:

When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in sketetally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Anterior Cervical Plate System.

When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disease ("DD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade I spondylolisthesis at the involved level(s). The Lanx Fusion System is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Lanx Spinal Fixation System. The Lanx SA standalone interbody implants, when implanted via an anterior approach and used with the integrated fixation screws, do not require use of supplemental fixation. The Lanx Lateral-SA implants are to be used with supplemental fixation.

When used as vertebral body replacement, the Lanx Intervertebrai Body/VBR Fusion System ("Lanx Fusion System") is indicated for use to replace a vertebral body that has been resected or excised due to turnor or traumalfracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e. T1- L5) for partial replacement (i.e., partial vertebral body resected or excised or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.

Prescription Use (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)

Anton E. Dmitriev, PhD Division of Orthopedic 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.