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:

o 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 (TI-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

Device Description

The Lanx Posterior Cervicothoracic Spinal Fixation System consists of various titanium alloy 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, allowing the surgeon to tailor the construct to the particular needs of the patient.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Lanx Posterior Cervicothoracic Spinal Fixation System," a Class II medical device. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing specific acceptance criteria and proving performance through detailed clinical or standalone studies with statistical endpoints as might be required for a PMA or novel device.

Therefore, the information requested regarding acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment, is largely not present in this 510(k) summary. The provided document emphasizes mechanical testing to show comparable properties to predicate devices.

Here's an attempt to answer based on the given text, noting when information is unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are implicitly based on demonstrating substantial equivalence to predicate devices, primarily through engineering analysis and performance testing showing comparable mechanical properties. Specific quantified acceptance criteria (e.g., "sensitivity > X%", "accuracy > Y%") for diagnostic performance are not applicable to this type of device and submission.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Summary)
Mechanical properties comparable to predicate devices.	"The device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate devices."
Intended use and indications for use are the same or similar to predicate devices.	"The Lanx Posterior Cervicothoracic Spinal Fixation System has the same or similar intended use, indications...as the predicate systems."
Technological characteristics and principles of operation are the same or similar to predicate devices.	"The Lanx Posterior Cervicothoracic Spinal Fixation System has the same or similar...technological characteristics, and principles of operation as the predicate systems."

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

The document mentions "Performance testing and engineering analysis was conducted." This typically refers to benchtop mechanical tests. The specific "sample size" (i.e., number of devices or components tested) is not specified. The "data provenance" (country of origin, retrospective/prospective) is not applicable as there is no human subject data or clinical data described here. The testing is laboratory-based.

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

This information is not applicable as the device is a spinal fixation system, not a diagnostic AI device requiring expert-established ground truth for its performance evaluation in this context. The "ground truth" for mechanical testing would be established by engineering standards and measurements.

4. Adjudication method for the test set

This information is not applicable as there is no diagnostic test set or human interpretation being adjudicated.

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

An MRMC study is not applicable here. This is a spinal fixation system, not an AI-powered diagnostic tool for human readers.

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

This is not applicable as the device is a spinal fixation system, not an algorithm. Performance of the device is assessed through mechanical testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the performance testing mentioned, the "ground truth" would be based on engineering specifications and measurements from mechanical testing (e.g., material strength tests, fatigue tests, torsional tests), benchmarked against established standards and predicate device performance. It is important to note that specific ground truth metrics (e.g., specific load at failure) are not detailed in this summary.

8. The sample size for the training set

This information is not applicable as the device is a hardware spinal fixation system, not an AI/machine learning model that uses a "training set."

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

This information is not applicable for the same reason as above; there is no training set for a hardware device.

Summary

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1092656

NUY 3 4 2009

510(k) SUMMARY

Lanx Posterior Cervicothoracic Spinal Fixation System

Submitter Information

Name and Address:	Lanx, Inc.
	390 Interlocken Crescent, Suite 890
	Broomfield, CO 80021
Contact Person:	Andrew Lamborne
Date Prepared:	August 26, 2009

Device Identification

Proprietary Name:	Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)
Common Name:	Spinal Fixation System
Classification:	MNI - 21 CFR 888.3070 - Pedicle Screw Spinal System
	KWP - 21 CFR 888.3050 - Spinal Interlaminal Fixation Orthosis

Predicate Device Information

K071905	Lanx PCFS	Lanx, Inc.
K030197	Ascent PCS	Blackstone Medical, Inc.
K042508	Summit/Mountaineer OCT	Depuy Spine, Inc.

Intended Use / Indications for Use

o 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 (TI-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

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Technological Characteristics

Performance Data

Performance testing and engineering analysis was conducted to characterize the performance of the Lanx Posterior Cervicothoracic Spinal Fixation System. The device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate devices.

Substantial Equivalence

The Lanx Posterior Cervicothoracic Spinal Fixation System has the same or similar intended use, indications, technological characteristics, and principles of operation as the predicate systems. Mechanical testing also demonstrated comparable mechanical properties to the predicate devices. Thus, the Lanx Posterior Cervicothoracic Spinal Fixation System is substantially equivalent to the predicate devices.

। ୧

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized caduceus symbol. The caduceus is a symbol of medicine and health, and it is depicted as a staff with two snakes coiled around it and wings at the top.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Lanx, Inc % Mr. Andrew Lamborne 390 Interlocken Crescent, Suite 890 Broomfield, Colorado 80021

NOV 2 4 2009

Re: K092656

Trade 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, MNI
Dated: August 26, 2009 Received: August 28, 2009

Dear Mr. Lambome:

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 (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.

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 mav 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 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

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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,

Jonetu Jr

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

KO92656

Device Name: Lanx Posterior Cervicothoracic Spinal Fixation System

Indications for Use:

510(k) Number (if known):

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)

signature

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

510(k) Number K092656

Pg 1 of 1

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.