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 a head-to-head cross connector and additional longitudinal rods and polyaxial pedicle screws. 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 consist 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,

Both the modified and predicate Lanx Posterior Cervicothoracic Spinal Fixation System implants are fabricated from medical grade titanium alloy per ASTM F136. The modified Lanx Posterior Cervicothoracic Spinal Fixation System implants are manufactured using the same manufacturing processes, and are passivated and anodized in the same manner as the implants in the predicate Lanx Posterior Cervicothoracic Spinal Fixation System.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (Lanx Posterior Cervicothoracic Spinal Fixation System) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving a device meets specific clinical acceptance criteria.

Therefore, many of the requested categories are not applicable to this type of regulatory submission, as it deals with mechanical performance and equivalence, not clinical efficacy or diagnostic accuracy.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance for Lanx Posterior Cervicothoracic Spinal Fixation System (K100888)

This submission is a 510(k) for adding a head-to-head cross connector, additional longitudinal rods, and polyaxial pedicle screws to an existing spinal fixation system. The primary goal is to demonstrate substantial equivalence to the predicate device (K092656), not to prove the device meets new, independent clinical performance acceptance criteria. The "acceptance criteria" here are implicitly related to the mechanical performance of the modified system being comparable to the predicate device, as tested by specific ASTM standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Implicit)	Specific Test/Standard	Reported Device Performance / Outcome
Mechanical Strength	Static and dynamic axial compression bending (in accordance with ASTM F1717)	Modified device performed as intended. Results compared to predicate system.
Mechanical Strength	Static and dynamic torsion testing (in accordance with ASTM F1717)	Modified device performed as intended. Results compared to predicate system.
Mechanical Strength	Axial grip testing (in accordance with ASTM F1798)	Modified device performed as intended. Results compared to predicate system.
Mechanical Strength	Cantilever bending testing (in accordance with ASTM F1798)	Modified device performed as intended. Results compared to predicate system.
Substantial Equivalence	Comparison of mechanical properties to predicate device	Mechanical testing demonstrated comparable mechanical properties to predicate.
Functionality	Meeting intended use	Modified device functioned as intended.
Safety and Effectiveness	No new issues raised by modifications	Modifications do not raise new issues of safety or effectiveness.
Material Equivalence	Fabricated from medical grade titanium alloy per ASTM F136	Implants are fabricated from the same material as the predicate.
Manufacturing Equivalence	Same manufacturing processes, passivation, and anodization as predicate	Implants are manufactured, passivated, and anodized in the same manner as predicate.

Study Proving Device Meets Acceptance Criteria:

The study was a series of mechanical performance tests conducted to characterize the modified Lanx Posterior Cervicothoracic Spinal Fixation System and compare it to the predicate device.

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

Sample Size: Not explicitly stated as numerical values for each test. The text mentions "the modified and predicate systems" were tested, implying a sufficient number of samples for each configuration to satisfy the ASTM standards.
Data Provenance: Not specified. This would typically be internal laboratory data generated by the manufacturer or a contracted testing facility. Given the regulatory context, it would be considered prospective for the purposes of this submission (i.e., tests specifically performed to support this submission). Country of origin is not mentioned.

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

Not Applicable. This is a mechanical testing study, not a study involving human interpretation or ground truth established by experts in a clinical context. The "ground truth" is defined by the physical properties and performance metrics specified by the ASTM standards.

4. Adjudication Method for the Test Set:

Not Applicable. Mechanical testing results are objective measurements from instruments; they do not involve human adjudication in the sense of reconciling subjective opinions.

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

No. This is a mechanical performance study, not a clinical or comparative effectiveness study involving human readers or cases.

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 fixation system), not an algorithm or AI software.

7. The Type of Ground Truth Used:

For the mechanical tests, the "ground truth" is defined by the metrics and pass/fail criteria established by the referenced ASTM standards (F1717 and F1798). The performance of the predicate device also serves as a comparative "truth" against which the modified device is evaluated for substantial equivalence.

8. The Sample Size for the Training Set:

Not Applicable. This is a physical device where "training sets" are not relevant in the way they are for AI/machine learning algorithms. Instead, the design and manufacturing processes are likely informed by prior engineering principles and data from similar devices.

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

Not Applicable. As above, the concept of a "training set" with established ground truth does not apply to this type of mechanical device submission. The design and testing methodologies are based on established engineering principles and industry standards (ASTM).

Summary

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K100888

NOV 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:	William Sandul
Date Prepared:	March 29, 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.
---------	-----------	------------

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 and Technological Characteristics

Performance Data

Performance testing was conducted to characterize the modified Lanx Posterior Cervicothoracic Spinal Fixation System. Static and dynamic axial compression bending and static and dynamic torsion testing were performed in accordance ASTM F1717 on the modified and predicate systems, and the results compared. Also, axial grip and cantilever bending testing was performed in accordance with ASTM F1798 on the modified and predicate system, and the results compared. The modified device functioned as intended and the observed test results demonstrate substantial equivalence to a 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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

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

NOV 1 5 2010

Re: K100888

Trade/Device Name: Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS) Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: October 19, 2010 Received: October 20, 2010

Dear Mr. Sandul:

We have reviewed vour 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

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Page 2 – Mr. William Sanduls

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 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 yours,

Barbary Mehind

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

NOV 1 5 2010

510(k) Number (if known): K100885

Device Name: Lanx Posterior Cervicothoracic Spinal Fixation System

Indications for Use:

When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occipyt-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 oriein 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 of Surgical, Orthopedic, and Restorative Devices

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K100888 510(k) Number_

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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.