When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following:

Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
Spondylolisthesis .
◆ Spinal Stenosis
Trauma/Fracture/Dislocation .
Atlanto-Axial Fracture with Instability .
Occipito-Cervical Dislocation .
Failed Previous Fusion .
Tumor .

The use of occipital bone screws is limited to placement in the occiput only.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

Device Description

The purpose of this 510(k) submission is to add modified rods, screws and hooks to the Lanx Posterior Cervicothoracic Spinal Fixation System. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.

Both the modified and predicate Lanx Posterior Cervicothoracic Spinal Fixation System consists of various screws, hooks, plates, rods, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, with the anchors and connectors rigidly locked to the rod, allowing the surgeon to tailor the construct to the particular needs of the patient.

The predicate Lanx Posterior Cervicothoracic Spinal Fixation System is fabricated from medical grade titanium alloy per ASTM F136. The modified system includes components fabricated from medical grade cobalt chrome alloy per ASTM F1537 in addition to the titanium components. As documented within this premarket notification, the addition of cobalt chrome alloy components does not raise new issues of safety or effectiveness. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the Lanx Posterior Cervicothoracic Spinal Fixation System, seeking clearance to add modified components and demonstrate substantial equivalence to a predicate device. The information provided focuses on the mechanical testing conducted and does not contain details about acceptance criteria, clinical study design, or performance metrics typically associated with AI/software-as-a-medical-device (SaMD) evaluations.

Therefore, many of the requested categories (2-9) are not applicable or cannot be answered from the provided text.

Here's an analysis of what can be extracted:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Criterion: The modified Lanx Posterior Cervicothoracic Spinal Fixation System must demonstrate substantial equivalence to the predicate device in terms of mechanical properties. Specific Test Requirements (Implied): - Static axial compression bending per ASTM F1717 - Dynamic axial compression bending per ASTM F1717 - Static torsion tests per ASTM F1717	Performance: The modified device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device in static axial compression bending, dynamic axial compression bending, and static torsion tests in accordance with ASTM F1717.

Study that Proves Device Meets Acceptance Criteria:

A non-clinical performance study was conducted to characterize the modified Lanx Posterior Cervicothoracic Spinal Fixation System.

Type of Study: Non-clinical (mechanical) performance testing.
Tests Performed: Static and dynamic axial compression bending and static torsion tests in accordance with ASTM F1717.
Comparison: The results of the modified system were compared to those of the predicate systems (Lanx PCFS K092656 and Solanas K052201).
Conclusion: The study found that the modified device functioned as intended and the observed test results demonstrated substantial equivalence to the predicate device. This conclusion serves as the proof that the device meets the acceptance criteria of mechanical equivalence.

Information Not Applicable or Not Provided:

The following information is not present in the provided 510(k) summary, as it is primarily a mechanical device submission and not related to AI/SaMD or clinical trial performance in the way the questions are framed:

Sample size used for the test set and the data provenance: Not applicable for a mechanical performance study. The test "set" would refer to the number of components or constructs tested, but this detail is not provided, nor is data provenance in the context of patient data.
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. Ground truth for mechanical testing is based on objective measurements from standardized tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: No MRMC study was conducted, as this is not an AI-enabled device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical implant device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" is derived from the physical properties and performance against ASTM standards.
The sample size for the training set: Not applicable as this is not a learning algorithm.
How the ground truth for the training set was established: Not applicable as this is not a learning algorithm.

Summary

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APR 1 5 2010

510(k) SUMMARY

Lanx Posterior Cervicothoracic Spinal Fixation System

Submitter Information

Name and Address:	Lanx, Inc.390 Interlocken Crescent, Suite 890Broomfield, CO 80021(303) 443-7500
Contact Person:	Andrew Lamborne
Date Prepared:	April 9, 2010

Device Identification

Proprietary Name:	Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)
Common Name:	Spinal Fixation System
Classification:	KWP - 21 CFR 888.3050 - Spinal Interlaminal Fixation Orthosis

Predicate Device Information

K092656	Lanx PCFS	Lanx, Inc.
K052201	Solanas	Alphatec Spine, Inc.

Intended Use / Indications for Use

Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
Spondylolisthesis .
◆ Spinal Stenosis
Trauma/Fracture/Dislocation .
Atlanto-Axial Fracture with Instability .
Occipito-Cervical Dislocation .
Failed Previous Fusion .
Tumor .

The use of occipital bone screws is limited to placement in the occiput only.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

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Device Description & Technological Characteristics

Performance Data

Non-clinical performance testing was conducted to characterize the modified Lanx Posterior Cervicothoracic Spinal Fixation System. Static and dynamic axial compression bending and static torsion tests in accordance with ASTM F1717 were performed on the modified and predicate systems, and the results compared. The modified device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device.

Substantial Equivalence

The modified Lanx Posterior Cervicothoracic Spinal Fixation System has the same intended use, indications, technological characteristics, and principles of operation as the predicate system. The modifications to the Lanx Posterior Cervicothoracic Spinal Fixation System do not raise new issues of safety or effectiveness. Also, mechanical testing demonstrated comparable mechanical properties to the predicate device. Thus, the modified Lanx Posterior Cervicothoracic Spinal Fixation System is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

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

APR 1 5 2010

Lanx, Inc. % Mr. Andrew Lamborne Vice President of Product Development 390 Interlocken Crescent, Suite 890 Broomfield, Colorado 80021

Re: K100191

Trade/Device Name: Lanx Posterior Cervicothoracic Spinal Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: March 23, 2010 Received: March 25, 2010

Dear Mr. Lamborne:

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

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Page 2 - Mr. Andrew Lamborne

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark A. Milken

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

1-100191 510(k) Number (if known): __

Device Name: Lanx Posterior Cervicothoracic Spinal Fixation System

Indications for Use:

Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
Spondylolisthesis .
Spinal Stenosis .
Trauma/Fracture/Dislocation ●
Atlanto-Axial Fracture with Instability .
. Occipito-Cervical Dislocation
. Failed Previous Fusion
. Tumor

The use of occipital bone screws is limited to placement in the occiput only.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

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

Page of of

K100191 510(k) Number_

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.