The Lanx Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The Lanx Anterior Cervical Plate System is suitable for use to provide temporary stabilization of the anterior spine while awaiting bony fusion (healing) in patients with degenerative disc disease (neck or radicular pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), or pseudoarthrosis and/or failed previous fusion between C1 and C6.

Device Description

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct "sway back", scoliosis (lateral curvature of the spine), or other conditions.

General description of the new plate.
Materials:
Titanium Alloy ASTM F136-92 ISO 5832-3
Titanium ASTM F67 GR2-95 ISO 5832-2
Cervical plates are offered for the following levels/configurations. These are offerings as detailed in the original submission.
One Level Two Level Three Level Four Level Five Level
Anatomically curved metallic plate
Manually applied locking mechanism

AI/ML Overview

The provided document describes the Lanx Anterior Cervical Plate System's 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria. This type of submission is common for Class II medical devices and typically relies on design, material, and performance comparisons to a previously cleared device. Therefore, much of the requested information (like specific acceptance criteria, sample sizes for test and training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) is not usually part of a 510(k) summary for such a device.

However, based on the provided text, I can infer and extract some relevant details pertaining to "acceptance criteria" through the lens of substantial equivalence and performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the new plates' performance is "equivalent to the previously cleared anterior cervical plates." The criteria for this equivalence are not explicitly numerical acceptance values in the text but are implied through the performance tests conducted.

Feature/Test	Acceptance Criteria (Implied)	Reported Device Performance
Fatigue Testing	Perform in an equivalent manner to previously cleared anterior cervical plates.	"Fatigue... testing is complete." "Test results demonstrate that the new plates perform in a manner equivalent to the previously cleared anterior cervical plates."
Static Testing	Perform in an equivalent manner to previously cleared anterior cervical plates.	"Static testing is complete." "Test results demonstrate that the new plates perform in a manner equivalent to the previously cleared anterior cervical plates."
Mechanical Properties (Materials)	Conform to ASTM F136-92 (Titanium Alloy), ISO 5832-3 (Titanium Alloy), ASTM F67 GR2-95 (Titanium), ISO 5832-2 (Titanium).	"Materials: Titanium Alloy ASTM F136-92, ISO 5832-3; Titanium ASTM F67 GR2-95, ISO 5832-2."
Indications for Use (Clinical Equivalence)	Same as the predicate device.	"SAME" (Indications for Use compared to predicate).
Design (Structural Equivalence)	Anatomically curved metallic plate, same as predicate.	"SAME" (Design compared to predicate).
Sterilization Method (Processing Equivalence)	Must be Autoclaved (NON-STERILE as supplied), same as predicate.	"SAME" (Sterile status compared to predicate).
Plate Sizes (Dimensional Equivalence)	Equivalent to predicate (1-level to 5-level, 18mm-118mm length in 2-5mm increments).	"EQUIVALENT" (Plate Sizes compared to predicate).
Material (Composition Equivalence)	Titanium Alloy, same as predicate.	"SAME" (Material compared to predicate).
Locking Mechanism (Functional Difference)	Not equivalent; new device has "Manually applied locking mechanism" vs. predicate's "Integral locking mechanism". This is noted as a difference but not explicitly tied to failed acceptance criteria but rather a design variation that must still meet overall safety/effectiveness.	"NO" (Locking Mechanism compared to predicate).

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

Sample Size for Test Set: The document states "Samples were tested according to accepted engineering and scientific principals." However, it does not specify the exact number of samples used for fatigue and static testing.
Data Provenance: The testing was conducted by LANX, LLC (the manufacturer), based on "accepted engineering and scientific principals." There is no information provided on the country of origin of data beyond the fact that LANX, LLC is based in Boulder, CO, USA. The testing described is retrospective (performed as part of the device development and submission process).

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

This information is not applicable or not provided in this 510(k) summary. For mechanical tests on a physical device, "ground truth" is established by direct measurement and established engineering principles and standards, not typically by expert review panels in the way it would be for diagnostic AI.

4. Adjudication Method for the Test Set:

This information is not applicable or not provided. Since the testing involves mechanical performance rather than subjective interpretation, there would be no "adjudication method" in the conventional sense (e.g., 2+1 review).

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or algorithms where human readers interpret medical images. The Lanx Anterior Cervical Plate System is an orthopedic implant, and its evaluation focuses on mechanical performance and substantial equivalence.

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

This question is not applicable. The device is a physical medical implant, not an algorithm. Therefore, "standalone" performance in this context refers to the device's mechanical integrity and function, which was evaluated through fatigue and static testing.

7. The Type of Ground Truth Used:

The ground truth for the performance claim (equivalence) is based on established engineering and scientific principles, including specific ASTM and ISO material standards, and the mechanical performance of previously cleared predicate devices. The "ground truth" for the device's actual mechanical properties (e.g., fatigue life, static strength) would be the physical measurements obtained during the tests.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" for physical mechanical devices in the way there is for AI/ML algorithms. The device's design and manufacturing process are informed by engineering principles, material science, and the performance of existing devices, not by a data-driven training process.

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

This information is not applicable as there is no training set in the context of this device. The design and validation of the device rely on adherence to established engineering standards and comparison to predicate devices, where the "ground truth" for those comparisons is derived from their own validated performance and specifications.

Summary

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KOSO774

APR 1 1 2005

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510(k) Summary Information	LANX, LLC.

Premarket Notification, Section 510(k)	MARCH 21, 2005

Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:

1. Device Name:

Lanx Anterior Cervical Plate System Trade Name:

Common Anterior cervical spine system Name(s):

Classification Spinal intervertebral body fixation orthosis. Name(s):

Establishment Name & Registration Number: 2.

Name:	LANX, LLC.
Number:	3004485144

3. Classification(s):

$ 888.3060 Spinal intervertebral body fixation orthosis. (a) Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct "sway back", scoliosis (lateral curvature of the spine), or other conditions. (b) Classification. Class 11.

Device Class:	Class II for all requested indications
Classification Panel:	Orthopaedic and Rehabilitation Devices Panel
Product Code(s):	KWQ

Equivalent Predicate Device: 4.

LANX, LLC. believes that the Lanx Anterior Cervical Plate System is substantially equivalent to the following:

Equivalence can be seen in the design, material composition, surgical technique and intended use.

5. Device Description:

General description of the new plate.

Materials:

Titanium Alloy	ASTM F136-92	ISO 5832-3
Titanium	ASTM F67 GR2-95	ISO 5832-2

Cervical plates are offered for the following levels/configurations. These are offerings as detailed in the original submission.

One Level Two Level Three Level Four Level Five Level

Cervical Special.doc

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Fatigue and static testing is complete. Samples were tested according to accepted Testing Summary. engineering and scientific principals. Test results demonstrate that the new plates perform in a manner equivalent to the previously cleared anterior cervical plates.

Applicant Name & Address: 6.

Lanx, LLC 1155 Alpine Avenue, Suite 320 Boulder, CO 80304 303-443-7500 Fax: 303-443-7501 fulton@lanx.us

7. Company Contact:

Michael Fulton, M.D. Lanx. LLC 1155 Alpine Avenue, Suite 320 Boulder, CO 80304 303-443-7500 Fax: 303-443-7501 fulton@lanx.us

Submission Correspondent: 8.

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

9. Performance Standards:

United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM, Standard Operating Procedures, vendor & process certification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality regulations.

LANX, LLC. also meets appropriate general controls authorized under Sections 501, 502, 518, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

Storage, Packaging & Sterilization Information: 10.

The Lanx Anterior Cervical Plate System is supplied "NON-STERILE" and must be sterilized prior The recommended sterilization process is high temperature steam autoclave sterilization. The to use. referenced sterilization cycle produces a Sterility Assurance Level (SAL) of at least 10°

The validated cycle is: Method: Steam Gravity Cycle: Temperature: 270°F (134°C) Exposure Time: 30 minutes

All packages containing implants or instruments should be intact upon receipt. Damaged packaging may indicate the presence of unsafe product. If the package or product is damaged, the product should not be used and should be returned.

Cervical Special.doc

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Product must be handled, stored and opened in such a way that it is protected from inadvertent damage or I rough mused, the product must be placed into use following cleaning, sterilization and accepted surgical sterile technique.

FEATURE	Lanx Anterior Cervical Plate System	Modified Anterior Cervical Plate.	SE?
Indications for Use:	Temporary stabilization of the anterior spine while awaitingbony fusion (healing) in patients with degenerative disc disease(neck or radicular pain of discogenic origin with degeneration ofthe disc confirmed by patient history and radiographic studies),trauma (including fractures), tumors, deformity (kyphosis,lordosis or scoliosis), or pseudoarthrosis and/or failed previousfusion.	SAME	YES
Design:	Anatomically curved metallic plate	SAME	YES
Sterile:	No - Must be Autoclaved	SAME	YES
Plate Sizes:	1-level to 5-level18mm - 118mm length in 2-5mm increments	EQUIVALENT	YES
Material:	Titanium Alloy	SAME	YES
LockingMechanism:	Manually applied locking mechanism	Intergral locking mechanism - no intra-operative assembly required	NO
Manufacturer:	Lanx, LLC	Lanx, LLC	YES
Product Code:	KWQ	KWQ	YES
K Number:	K040401	Pending	YES

Summary Comparison Table: 12.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - U.S.A." is arranged in a circular pattern around the eagle.

APR 1 1 2005

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lanx, LLC C/o Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523

Re: K050774

Trade/Device Name: Lanx Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: March 20, 2005 Received: March 25, 2005

Dear Mr. Schlerf:

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 such 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); 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.

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Page 2 - Mr. David W. Schlerf

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally presticated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general militiremational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Stup Rhodes
Miriam Provost, Ph.D.

Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KOSO774

Page l

510(k) Number: K050774

Lanx Anterior Cervical Plate System Device Name(s):

Indications For Use:

Warning: This device is not cleared for screw attachment to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Prescription Use OR Over-The-Counter Use PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Stypk Pluder

(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number K050774

(Optional format 1-2-96)

(Per 21 CFR 801.109)

Cervical Special.doc

Page 1 of 1

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.