The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The System is intended for use with autograft or allograft.

The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Device Description

The Lanx 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.

AI/ML Overview

The provided text describes the Lanx Spinal Fixation System, primarily focusing on its intended use, technological characteristics, and its substantial equivalence to predicate devices, which led to its FDA clearance. However, it does not include a detailed study with acceptance criteria and reported device performance in the way a clinical study or performance verification test report would.

The document is a 510(k) summary, which is a premarket notification to the FDA. For devices like spinal fixation systems, the primary "acceptance criteria" for 510(k) clearance often revolve around demonstrating substantial equivalence to a predicate device, as opposed to proving novel clinical efficacy or meeting specific statistical performance thresholds in a clinical trial.

Based on the provided text, here's a breakdown of the requested information, noting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with quantitative acceptance criteria and reported device performance metrics in the typical sense (e.g., sensitivity, specificity, accuracy for a diagnostic device, or specific load-bearing limits for an orthopedic implant compared to a defined standard).

Instead, the "acceptance criteria" are implied by the FDA's requirement for substantial equivalence. The performance reported is that "The Lanx Spinal Fixation System functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device."

Implied Acceptance Criterion: Demonstrate substantial equivalence to legally marketed predicate devices in terms of safety and effectiveness.
Reported Device Performance: "The Lanx Spinal Fixation System functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "Performance testing and engineering analysis was performed and submitted to characterize the system." However, it does not specify the sample size used for these tests, nor does it detail the nature of the "test set" (e.g., whether it refers to physical prototypes, cadaveric samples, or data from human subjects). It also does not mention data provenance (country of origin, retrospective/prospective). This information is typically found in detailed test reports, not the 510(k) summary.

3. 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)

This information is not applicable to this type of submission. The device is a spinal fixation system, not a diagnostic or AI-driven device requiring expert-established ground truths for performance evaluation during a 510(k) submission. The "ground truth" for a mechanical device is typically established through engineering standards and physical testing against those standards or predicate device performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable as there is no mention of a test set requiring adjudication in the context of human expert review for establishing ground truth or evaluating diagnostic performance.

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

This information is not applicable. An MRMC study is typically for evaluating diagnostic imaging devices or AI algorithms that assist human readers. The Lanx Spinal Fixation System is an orthopedic implant and does not involve "human readers" or AI assistance in this context.

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

This information is not applicable. The device is a mechanical implant, not an algorithm.

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

For a mechanical implant, the "ground truth" during performance testing would typically be established through engineering standards, biomechanical testing protocols, and comparison to the known performance of predicate devices. The document refers to "Performance testing and engineering analysis" which implies these methods were used. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for the engineering evaluation described.

8. The sample size for the training set

This information is not applicable. The device is a mechanical implant and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable for the same reason as point 8.

Summary of Study (Based on Provided Text):

The "study" described is primarily focused on demonstrating substantial equivalence for a 510(k) premarket notification.

Type of Study: Performance testing and engineering analysis (likely biomechanical testing, material testing, and design comparisons).
Purpose: To characterize the system and demonstrate that it is as safe and effective as identified predicate devices.
Key Finding: "The Lanx Spinal Fixation System functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device."
Absence of Detail: The 510(k) summary does not provide specific quantitative results, detailed test methodologies, sample sizes for testing, or information about expert involvement in establishing "ground truth" because these are not typically required at a high level in the summary document for this type of device. The FDA's clearance is based on the comprehensive testing performed and submitted to them, which is abstracted in this summary.

Summary

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510(k) SUMMARY

Lanx Spinal Fixation System

OCT 3 0 2009

Submitter Information

Name and Address:	Lanx, Inc.390 Interlocken Crescent, Suite 890Broomfield, CO 80021
Contact Person:	Andrew Lamborne
Date Prepared:	August 14, 2009

Device Identification

Proprietary Name:	Lanx Spinal Fixation System
Common Name:	Spinal Fixation System
Classification:	Pedicle Screw Spinal System 21 CFR 888.3070 and/or SpinalInterlaminal Fixation Orthosis 21 CFR 888.3050
Product Codes:	MNI, MNH, KWP, NKB

Predicate Device Information

Lanx Spinal Fixation System, Lanx, Inc.

Stryker Spine Xia 3 Spinal System, Stryker Spine

Expedium Spine System, DePuy Spine, Inc.

Intended Use / Indications for Use

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Technological Characteristics

Performance Data

Performance testing and engineering analysis was performed and submitted to characterize the system. The Lanx Spinal Fixation System functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device.

Substantial Equivalence

The modified Lanx Spinal Fixation System is as safe and effective as the predicate devices. The Lanx Spinal Fixation System has the same intended use, indications, technological characteristics, and principles of operation as the predicate systems. The modifications do not raise any new issues of safety or effectiveness. Thus, the modified Lanx Spinal Fixation System is substantially equivalent to the predicate devices.

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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 an abstract symbol that resembles a stylized human figure or bird in flight.

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

OCT 3 0 2009

Lanx, Inc. % Hogan & Hartson LLP Ms. Janice M. Hogan Regulatory Counsel 1835 Market Street Suite 2820 Philadelphia, Pennsylvania 19103

Re: K092536

Trade/Device Name: Lanx Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWP, MNH, MNI Dated: August 14, 2009 Received: August 19, 2009

Dear Ms. Hogan:

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.

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

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Page 2 - Ms. Janice M. Hogan

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerelv vours.

Mark M. Wilkerson

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

510(k) Number (if known):

Device Name: Lanx Spinal Fixation System

Indications for Use:

X Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

. Page of

K092536 510(k) Number_

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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.