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 implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Spinal Fixation System.

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 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 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 lissues, 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 svstem.

Device Description

All implants in the Lanx Fusion System are manufactured from PEEK-OPTIMA® LT1 per ASTM F2026, titanium alloy (Ti-6Al-4V) per ASTM F136, and tantalum per ASTM F560. The implants have a hollowed out area to accommodate autogenous bone graft, and transverse grooves to improve fixation and stability. The implants are offered in a variety of footprints and heights to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Fusion System is provided non-sterile.

AI/ML Overview

Lanx Intervertebral Body/VBR Fusion System - Acceptance Criteria and Study Details

The provided document describes a 510(k) submission for a product line extension of the Lanx Intervertebral Body/VBR Fusion System. As such, the focus of the study is to demonstrate that the modified device is substantially equivalent to previously cleared predicate devices and does not raise new safety or efficacy concerns.

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Stated)	Reported Device Performance
Static Compression	Meets established criteria for mechanical properties comparable to predicate devices.	"In all instances, the Lanx Fusion System met the established acceptance criteria and performed as intended."
Dynamic Compression	Meets established criteria for mechanical properties comparable to predicate devices.	"In all instances, the Lanx Fusion System met the established acceptance criteria and performed as intended."
Static Torsion	Meets established criteria for mechanical properties comparable to predicate devices.	"In all instances, the Lanx Fusion System met the established acceptance criteria and performed as intended."
Dynamic Torsion	Meets established criteria for mechanical properties comparable to predicate devices.	"In all instances, the Lanx Fusion System met the established acceptance criteria and performed as intended."
Subsidence Testing	Meets established criteria for mechanical properties comparable to predicate devices.	"In all instances, the Lanx Fusion System met the established acceptance criteria and performed as intended."
Overall Substantial Equivalence	The modified device is as safe and effective as the predicate devices and does not raise new issues related to safety or efficacy.	"Performance data demonstrate that these additions to the Lanx Fusion System do not raise new issues related to safety or efficacy; hence the modified system is as safe and effective as the predicate devices. Thus, the modified device is substantially equivalent."

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

The document describes mechanical testing performed to establish performance. Specific sample sizes for each test are not explicitly stated in the provided text. The data provenance is also not explicitly stated beyond being part of the manufacturer's internal testing process for regulatory submission. It is implicitly prospective data generated to support the 510(k) submission.

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

This type of information is not applicable to the described study. The study consisted of mechanical testing of the device itself, not an evaluation of diagnostic accuracy or clinical outcomes requiring human expert interpretation or a "ground truth" to be established in that sense.

4. Adjudication Method for the Test Set

This is not applicable to mechanical testing. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints where discrepancies in observations need to be resolved.

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

No, an MRMC comparative effectiveness study was not conducted. This study focused on the mechanical performance of the device itself, not on the impact of the device on human reader performance.

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

This is not applicable to the described medical device. The Lanx Fusion System is a physical orthopedic implant, not an algorithm or a software device. The "standalone" performance here refers to the device's mechanical integrity on its own.

7. The Type of Ground Truth Used

The "ground truth" for this study was established through recognized industry standards (ASTM F2077 and ASTM F2267) and the performance characteristics of the predicate devices. The criteria against which the mechanical tests were judged were based on these established standards and the expected performance of similar, already cleared devices.

8. The Sample Size for the Training Set

This concept is not applicable to the described study. There is no "training set" in the context of mechanical performance testing of a physical implant. The design and manufacturing process for the device would have been developed and refined, but this is distinct from a "training set" for an algorithm.

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

This is not applicable for the reasons stated in point 8.

Summary

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

FEB 2 8 2011

510(k) SUMMARY

Lanx Intervertebral Body/VBR Fusion System

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

Lanx, Inc. 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021

Phone: 303-443-7500 Facsimile: 303-443-7501

Contact Person: William Sandul Date Prepared: December 14, 2010

Name of Device and Name/Address of Sponsor

Lanx Fusion System

Lanx, Inc. 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021

Common or Usual Name

Intervertebral Body/VBR Fusion System

Classification Name

21 CFR 888.3080 - Intervertebral Body Fusion Device 21 CFR 888.3060 - Spinal Intervertebral Body Fixation Orthosis

Predicate Device(s)

Lanx Intervertebral Body/VBR Fusion System (K083815) LDR Spine MC+ Cervical Interbody Fusion System (K091088) Spinal Elements Crystal Cervical Cage System (K073351)

Description of Device Modification

This submission is intended to seek clearance for a product line extension to the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System"). The product line extension includes additional cervical intervertebral body fusion device implants with increased graft volume, additional larger implant footprints, implants with a convex superior endplate, and modifications to accommodate a threaded inserter.

sheet 1 of 3

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

Statement of Technological Comparison

The additional cervical intervertebral body fusion device implants have the same intended use and indications, principles of operation, and technological characteristics as the cervical intervertebral body fusion device implants of the previously-cleared Lanx Fusion System. The minor differences between the modified and previously-cleared systems do not raise any new issues related to safety or efficacy. Mechanical testing demonstrated comparable mechanical properties between the modified and predicate devices.

Intended Use / Indications for Use

sheet 2 of 3

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

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 svstem.

Performance Data

Performance was established via mechanical testing that included static and dynamic compression and static and dynamic torsion per ASTM F2077 and subsidence testing per ASTM F2267. In all instances, the Lanx Fusion System met the established acceptance criteria and performed as intended.

Substantial Equivalence

The Lanx Fusion System is as safe and effective as the predicate Lanx Fusion System (K083815), LDR Spine MC+ Cervical Interbody Fusion System (K091088), and the Spinal Elements Crystal Cervical Cage System (K073351).

The additional cervical intervertebral body fusion device implants included in the product line extension have the same intended use, indications, technological characteristics, and principles of operation as the cervical intervertebral body fusion device implants of the previously-cleared Lanx Fusion System (K083815). Performance data demonstrate that these additions to the Lanx Fusion System do not raise new issues related to safety or efficacy; hence the modified system is as safe and effective as the predicate devices. Thus, the modified device is substantially equivalent.

sheet 2 of 3

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

Lanx, Inc. % Mr. William Sandul 390 Interlocken Crescent, Suite 890 Broomfield, Colorado 80021

Re: K103660

Trade/Device Name: Lanx Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MQP Dated: February 15, 2011 Received: February 17, 2011

FEB 2 8 2011

Dear Mr. Sandul:

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

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

Page 2 - Mr. William Sandul

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 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Aing B. M
fu

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

Enclosure

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

Indications for Use Statement

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 skeletally mature patients with degenerative disc disease ("DD") 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 ("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 or retrolisthesis at the involved level(s). The Lanx Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Spinal Fixation System.

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., TI- 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

sheet 1 of 2

{6}------------------------------------------------

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of 2

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

510(k) Number K103660

sheet 2 of 2

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.