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 grafi 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. TI- L5) for partial replacement (i.e., partial vertebrectonv) 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 purpose of this 510(k) submission is to include additional PEEK spacer and titanium screw fixation configurations to the Lanx SA System. The new Lanx Lateral-SA system has the same intended use, principles of operation, and technological characteristics as the current Lanx SA svstem.

The Lanx Lateral-SA System devices are made of PEEK (OPTIMA®) per ASTM F2026 and/or Titanium alloy (Ti-6AI-4V ELI) per ASTM F136. The PEEK components include Tantalum markers per ASTM F560. The Fusion System 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 Lanx Lateral-SA System is provided non-sterile.

AI/ML Overview

The Lanx Lateral-SA System is a medical device intended for spinal fusion procedures and vertebral body replacement. The acceptance criteria and supporting study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria	Reported Device Performance
Mechanical Performance	ASTM F2077 (Static Compression)	Not explicitly stated, but implied to meet or exceed predicate device performance.	"Modified device met or exceeded predicate device performance."
Mechanical Performance	ASTM F2077 (Dynamic Compression)	Not explicitly stated, but implied to meet or exceed predicate device performance.	"Modified device met or exceeded predicate device performance."
Mechanical Performance	ASTM F2077 (Static Torsion)	Not explicitly stated, but implied to meet or exceed predicate device performance.	"Modified device met or exceeded predicate device performance."
Subsidence Resistance	ASTM F2267 (Subsidence)	Not explicitly stated, but implied to meet or exceed predicate device performance.	"Modified device met or exceeded predicate device performance."
Wear Debris	ASTM F1877 (Wear Debris)	Not explicitly stated, but implied to meet or exceed predicate device performance.	"Modified device met or exceeded predicate device performance."
Overall Equivalence	Substantial Equivalence to Predicate Device (K102738)	Demonstrate comparable safety and effectiveness to the predicate device.	"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 SA system devices. Thus, the modified device has been shown to be substantially equivalent to the predicate device."

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

The document describes performance testing and engineering analysis to demonstrate substantial equivalence. It does not provide specific sample sizes (e.g., number of devices tested) for the ASTM tests mentioned (F2077, F2267, F1877). These tests typically involve a defined number of samples to ensure statistical validity, but the exact count is not disclosed in this summary.

The data provenance is laboratory-based engineering testing, rather than clinical data from human subjects. The report does not mention any country of origin for the data beyond being submitted to the FDA in the US, nor does it specify if the testing itself was retrospective or prospective in a clinical sense. It's prospective in the context of device development.

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

Not applicable. This submission relies on engineering and performance testing against established ASTM standards, not on expert interpretation of medical images or patient outcomes. Therefore, there's no "ground truth" in the sense of expert consensus on clinical findings.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

Not applicable. There was no clinical study involving human readers or interpretation requiring adjudication. Performance was evaluated against objective engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This document does not describe an MRMC study or any study involving human readers with or without AI assistance. The submission focuses on the mechanical and material equivalence of the device to its predicate.

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

Not applicable. This is a physical medical device (spinal implant), not a software algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant here.

7. The Type of Ground Truth Used:

The ground truth for the performance claim is based on established engineering standards (ASTM F2077, ASTM F2267, ASTM F1877) and a comparison to the mechanical properties of a predicate device (K102738). The "ground truth" is that the device must meet or exceed the performance of the predicate device under these standardized conditions.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

Not applicable. As described above, there is no "training set" in the context of this device's evaluation.

Summary

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510(k) SUMMARY

MAR 1 8 2013

Lanx, Inc's Intervertebral Body/VBR Fusion System

Submitter's Information

Name and Address:	Lanx, Inc.310 Interlocken Parkway, Suite 120Broomfield, CO 80021(303) 443-7500
Contact Person:	Alan Burkholder
Date Prepared:	March 12, 2013

Device Identification

Proprietary Name:	Lanx Lateral-SA 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 § 888.3080and/or § 888.3060) (OVD, MAX, MQP, ODP)

Predicate Device Information

K102738 Lanx SA System

Intended Use / Indications for Use

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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.

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 torsion). ASTM F2267 (subsidence) and ASTM F1877 (wéar debris). In all instances, the modified device met or exceeded predicate device performance,

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functioned as intended and therefore demonstrated substantial equivalence to the predicate device.

Substantial Equivalence

The Lanx Lateral-SA system implants included in the product line extension have the same intended use, technological characteristics, and principles of operation as the previously cleared Lanx SA devices (K102738). 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 SA system devices. Thus, the modified device has been shown to be substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 18, 2013

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

Re: K123767

Trade/Device Name: Lanx Lateral-SA System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX, MQP, ODP Dated: February 8, 2013 Received: February 7, 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

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Page 2 – Mr. Alan Burkholder

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 yours,

Erin] 《eith

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 Statement

510(k) Number (if known): K123767

Device Name: Lanx Lateral-SA 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 ("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 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. 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.

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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)

Stephanie Bechtold -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123767

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.