DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient . history and radiographic studies)
. Spondylolisthesis
. Spinal stenosis
. Fracture/dislocation
. Failed previous fusion
. Tumors

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 -T3) spine.

The pedicle screws are limited to placement in T1 -T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

Device Description

The purpose of this 510(k) submission is to add reduction polyaxial screws and curved rods. The LEXUS Cervical Spinal Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyaxial screws, reduction poly screws, straight rods, curved rods, set screws, and hooks.

Materials: All products are made of titanium alloy (Ti-6A1-4V ELI/ in conformance with ASTM F136) approved for medical use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the LEXUS Cervical Fixation System:

This device (LEXUS Cervical Fixation System) is a Spinal Fixation System, and its "performance" is evaluated based on mechanical testing, not on parameters usually associated with AI/software devices (like sensitivity, specificity, or accuracy in diagnosing conditions). Therefore, many of the typical questions for AI medical devices (like expert adjudication, MRMC studies, training set details, etc.) are not applicable to this type of medical device submission.

The acceptance criteria here relate to the structural integrity and mechanical properties of the implants.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Measure)	Reported Device Performance (Reference Standard)
Static Axial Compression Strength	Tested according to ASTM F1717
Dynamic Axial Compression Strength	Tested according to ASTM F1717
Static Tension Strength	Tested according to ASTM F1717
Static Torsion Strength	Tested according to ASTM F1717

Explanation: The "acceptance criteria" for this physical device are the standards set by ASTM F1717 for spinal fixation systems. The "reported device performance" indicates that the device was tested against and found to meet these established standards. The submission asserts that because it meets these recognized consensus standards, it is substantially equivalent in safety and effectiveness to predicate devices.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of a number of physical implants, but mechanical testing typically involves a sufficient number of samples to ensure statistical validity for the specific tests outlined in ASTM F1717.
- Data Provenance: The testing was conducted in the context of the manufacturer's submission for regulatory approval. The country of origin for the device manufacturer is South Korea. The study is prospective in the sense that the sponsor conducted the tests specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a mechanical device, ground truth in terms of clinical diagnosis or interpretation by experts is not relevant. The "ground truth" for mechanical testing is established by the specifications and methodologies defined in the ASTM F1717 standard itself. The results are physical measurements, not expert interpretations.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used for expert disagreements on qualitative assessments (e.g., image interpretation). This is a mechanical performance test.
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:
- Not Applicable. This is not an AI/software device and does not involve human readers interpreting data.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is adherence to the mechanical performance standards and methodologies specified by ASTM F1717. This includes physical properties like strength, stiffness, and resistance to fatigue under various loads, which are measured objectively.
The sample size for the training set:
- Not Applicable. This is a hardware medical device, not a machine learning model; therefore, there is no "training set."
How the ground truth for the training set was established:
- Not Applicable.

Summary of Device Performance Claim:

The L&K BIOMED LEXUS Cervical Fixation System's performance and safety are demonstrated by its compliance with internationally recognized mechanical testing standards (ASTM F1717). This standard evaluates static and dynamic axial compression, static tension, and static torsion. By meeting these benchmarks, the manufacturer asserts substantial equivalence to predicate devices, implying its safety and effectiveness for its intended use as a spinal fixation system.

Summary

{0}------------------------------------------------

K120879,

MAY 2 3 2012

ge if2:

L&K BIOMED

510(k) SUMMARY

The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):

1.	Submitter:	L&K BIOMED Co., Ltd.#1104, Ace High-end Tower 3 cha, 371-50, Gasan-Dong,Geumcheon-gu, Seoul 153-803 Republic of KoreaPhone.82-2-2624-1475FAX.82-2-2624-1477
	Contact Person:	KiHyang KimE-mail : khkim@lnkbiomed.com
	Date prepared:	March 23, 2012

2. Device Identification

Proprietary Name	LEXUS Cervical Fixation System
Common Name	Spinal Fixation System
Product Code	MNI, KWP
Regulatory Class	II
Classification Name	Pedicle Screw Spinal System (21CFR888.3070)Spinal Interlaminal Fixation Orthosis (21CFR888.3050)

3. Predicate or legally marketed devices which are substantially equivalent

. Spinal Concept Inc. / Nex-Link Spinal Fixation (K031985)
. Aesculap Inc. / S4 Spinal Fixation (K050979, K060152)
Medtronic Sofamor Danek USA Inc. / VERTEX "M Reconstruction System (K003780)
L&K BIOMED Co.,Ltd. / LEXUS Cervical Fixation System (K103414)

4. Description of the Device

Materials: All products are made of titanium alloy (Ti-6A1-4V ELI/ in conformance with ASTM F136) approved for medical use.

Special 510(K)

Page 16/ 55

{1}------------------------------------------------

page 2 of 2

L&K BIOMED

5. Intended use

The LEXUS Cervical Fixation System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by . patient history and radiographic studies)
. Spondylolisthesis
. Spinal stenosis
. Fracture/dislocation
. Failed previous fusion
. Tumors '

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 -T3) spine.

The pedicle screws are limited to placement in T1 -T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

6. Comparison of the technology characteristics of the device to predicate and legally marketed devices

The LEXUS Cervical Fixation System is considered substantially equivalent to other legally marketed devices. They are similar in design, material, and indications for use and are expected to be equivalent in safety and effectiveness.

7. Performance Data

The LEXUS Cervical Fixation System is tested according to the ASTM F1717, specifically, Static and Dynamic Axial Compression, Static Tension and Static Torsion.

8. Conclusion

The LEXUS Cervical Fixation System is substantially equivalent to the devices referenced above and is therefore safe and effective for its intended use.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be a sans-serif font.

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

L&K Biomed Co., Ltd. % Ms. Ki Hyang Kim #1104, Ace High-End Tower 3 cha 371-50, Gasan-Dong, Geumcheon-gu Seoul, 153-803, Republic of Korea

Re: K120879

Trade/Device Name: Lexus Cervical Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, KWP Dated: May 03, 2012 Received: May 04, 2012

Dear Ms. Kim:

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

7 3 2012 MAY

{3}------------------------------------------------

Page 2 - Ms. Ki Hyang Kim

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

Sincerely your

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

L&K BIOMEI

Indications for Use

510(k) Number : K120879

Device Name : LEXUS Cervical Fixation System

Indications for Use :

The LEXUS Cervical Fixation System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient . history and radiographic studies)
. Spondylolisthesis
. Spinal stenosis
. Fracture/dislocation
. Failed previous fusion
. Tumors

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 -T3) spine.

The pedicle screws are limited to placement in T1 -T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ V (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)

Special 510(K)

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

Page 14/ 55

	1000
--	------

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.