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

Device Description

The purpose of this Special 510(k) is to add a modified screw configuration in multiple sizes. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.
The Lanx Posterior Cervicothoracic Spinal Fixation System consists of various screws, hooks, rods, plates, 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.
The Lanx Posterior Cervicothoracic Spinal Fixation System implants are fabricated from medical grade titanium alloy and/or cobalt chrome alloy per ASTM F136 and ASTM F1537. 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

This document describes the Lanx Posterior Cervicothoracic Spinal Fixation System, which is a spinal fixation system that provides supplemental stabilization of spinal segments to support fusion. This submission is a Special 510(k) to add a modified screw configuration in multiple sizes. The device is substantially equivalent to a predicate device and is intended for use in the occipito-cervico-thoracic region of the spine in skeletally mature patients for various conditions.

Here's the information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (based on predicate device)	Reported Device Performance
Static Axial Compression	Functioned as intended and demonstrated substantial equivalence to the predicate device.	Functioned as intended and demonstrated substantial equivalence to the predicate device.
Dynamic Axial Compression	Functioned as intended and demonstrated substantial equivalence to the predicate device.	Functioned as intended and demonstrated substantial equivalence to the predicate device.
Static Torsion	Functioned as intended and demonstrated substantial equivalence to the predicate device.	Functioned as intended and demonstrated substantial equivalence to the predicate device.
Static Flexion-Extension	Functioned as intended and demonstrated substantial equivalence to the predicate device.	Functioned as intended and demonstrated substantial equivalence to the predicate device.

Note: The document explicitly states "functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device." This implies that the acceptance criteria for the modified device were to perform comparably to the previously-cleared predicate device in the specified mechanical tests. The specific quantitative thresholds for "substantial equivalence" or "functioned as intended" are not provided in this summary.

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

Sample Size: Not explicitly stated. The document mentions "Performance testing was conducted to characterize the modified components of the system. Tests were performed on the modified and predicate systems..." This implies a comparative test, but the number of units tested is not specified.
Data Provenance: Not applicable in the context of device performance testing. The tests are experimental/laboratory-based, not based on patient data.

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

Not applicable. This is mechanical performance testing of a physical device, not an AI/software device that requires expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is mechanical performance testing of a physical device.

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

No. This document describes the mechanical performance testing of a spinal fixation system, not a study involving human readers or AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This document is about a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the mechanical performance testing, the "ground truth" is established by the standardized test methods outlined in ASTM F1717 and ASTM F1798. The performance of the predicate device serves as the benchmark against which the modified device's performance is compared to establish substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model.

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

Not applicable. This is a physical medical device, not a machine learning model.

Summary

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K103040 age 1/2

510(k) SUMMARY

Lanx Posterior Cervicothoracic Spinal Fixation System

FEB - 8 2011

Submitter Information

Lanx, Inc. 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021 (303) 443-7500 Contact Person: Damon Belloni Date Prepared: January 12, 2011

Device Identification

Proprietary Name:	Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)
Common Name:	Spinal Fixation System
Classification:	Pedicle Screw Spinal System (MNI, NKB), 21 CFR 888.3070and/orSpinal Interlaminal Fixation Orthosis (KWP), 21 CFR 888.3050
Device Class:	Class II and Class III

Predicate Device Information

K071905, K092656, K100191, K100888 Lanx PCFS:

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 (TI-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

The Lanx Posterior Cervicothoracic Spinal Fixation System consists of various screws, hooks, rods, plates, 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.

The Lanx Posterior Cervicothoracic Spinal Fixation System implants are fabricated from medical grade titanium alloy and/or cobalt chrome alloy per ASTM F136 and ASTM F1537. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

Performance Data

Performance testing was conducted to characterize the modified components of the system. Tests were performed on the modified and predicate systems in accordance with ASTM F1717 (static and dynamic axial compression, static torsion) and ASTM F1798 (static flexion-extension). The Lanx Spinal Fixation System functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device.

Substantial Equivalence

The modified components of the Lanx Posterior Cervicothoracic Spinal Fixation System have the same intended use and indications, and the same or very similar technological characteristics and principles of operation as the predicate system. The minor differences in the modified components do not raise new issues of safety or effectiveness. Mechanical testing also demonstrated comparable mechanical properties to the previously cleared Lanx Posterior Cervicothoracic Spinal Fixation System. Thus, the modified Lanx Posterior Cervicothoracic Spinal Fixation System is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

FEB - 8 2011

Lanx, Inc. % Mr. Damon Belloni 390 Interlocken Crescent, Suite 890 Broomfield. Colorado 80021

Re: K103040

Trade/Device Name: Lanx Posterior Cervicothoracic Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, KWP Dated: January 12, 2011 Received: January 14, 2011

Dear Mr. Belloni:

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

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Page 2 – Mr. Damon Belloni

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/ReportalProblem/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.

Al. B. Rh

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

K103640 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-
(21 C

The-Counter Use FR 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

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

Page of of

510(k) Number K103040

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.