(242 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as a spinal fixation system that provides stabilization as an adjunct to fusion. This indicates it is a surgical implant designed to support the spine, rather than a device that delivers therapy to treat a condition directly.
No
The text indicates that the LEXUS Cervical Fixation System is a surgical implant designed to provide stabilization and promote fusion in the spine, particularly in the cervical/upper thoracic region, as an "adjunct to fusion." It is a "spinal fixation system" consisting of polyaxial screws, rods, set screws, and hooks. These are mechanical components used in surgical procedures, not diagnostic tools that identify or characterize diseases.
No
The device description explicitly states it is a "multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyaxial screws, rods, set screws, and hooks," all made of titanium alloy. This indicates it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The LEXUS Cervical Fixation System is a surgical implant designed to provide stabilization to the spine. It is a physical device implanted into the body.
- Intended Use: The intended use clearly describes the device's function as a fixation system for spinal conditions, not for testing biological samples.
Therefore, based on the provided information, the LEXUS Cervical Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
MNI, KWP
Device Description
The LEXUS Cervical Spinal Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyaxial screws, rods, set screws, and hooks.
Materials: All products are made of titanium alloy (Ti-6Al-4V ELI/ in conformance with ASTM F136) approved for medical use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (Cervical/Upper Thoracic C1-T3, Thoracic T1-T3)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The LEXUS Cervical Fixation System is tested according to the ASTM F1717, specifically, Static and Dynamic Axial Compression, Static Tension and Static Torsion.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K031985, K050979, K060152, K003780
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K103414 Page 1/2
L&K BIOMED
510(k) Summary
JUL 222 2011
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
| 1. Submission Information | |
|---|---|
| • US Agent: | Kevin Ahn |
| Address: | 20505 Valley Blvd, Suite 111 Walnut, CA91786 |
| Phone No: | 909-595-7746 |
| Fax: | 909-595-7747 |
| E-Mail: | Kevinahn@live.com |
| • Applicant: | L&K BIOMED Co., Ltd. |
| Address: | Room1104, ACE High-End Tower3, 371-50, Gasan-dong, |
| Geumcheon-gu, Seoul, 153-803 Republic of Korea | |
| Phone No: | 82-2-2624-1471 |
| Fax: | 82-2-2624-1477 |
| • Manufacturer: | L&K BIOMED Co., Ltd. |
| Address: | Room1104, ACE High-End Tower3, 371-50, Gasan-dong, |
| Geumcheon-gu, Seoul, 153-803 Republic of Korea | |
| Phone No: | 82-2-2624-1471 |
| Fax: | 82-2-2624-1477 |
| • Official Correspondent: | Hee-kyeong Joo |
| Address: | Room1104, ACE High-End Tower3, 371-50, Gasan-dong, |
| Geumcheon-gu, Seoul, 153-803 Republic of Korea | |
| Phone No: | 82-2-2624-1471 |
| Fax: | 82-2-2624-1477 |
| E-mail: | hkjoo83@gmail.com |
| Date Prepared: | July 04, 2011 |
2. Device Identification
| Trade Name | LEXUS Cervical Fixation System
(TRIUS Cervical Fixation System ) |
|---------------------|------------------------------------------------------------------------------------------------------|
| Common Name | Spinal Fixation System |
| Classification Name | Pedicle Screw Spinal System (21CFR888.3070)
Spinal Interlaminal Fixation Orthosis (21CFR888.3050) |
| Product Code | MNI, KWP |
| Device Class | Class II |
Predicate or legally marketed devices which are substantially equivalent 3.
- Spinal Concept,Inc. / Nex-Link Spinal Fixation (K031985) ー
- Aesculap, Inc. / S4 Spinal Fixation (K050979, K060152) -
- Medtronic Sofamor Danek USA,Inc. / VERTEX ™ Reconstruction System (K003780) "
1
K 103414 Page 2/2
L&K BIOMED
4. Device Description
The LEXUS Cervical Spinal Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyaxial screws, rods, set screws, and hooks.
Materials: All products are made of titanium alloy (Ti-6Al-4V ELI/ in conformance with ASTM F136) approved for medical use.
રું છ 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.
Performance Data 6.
The LEXUS Cervical Fixation System is tested according to the ASTM F1717, specifically, Static and Dynamic Axial Compression, Static Tension and Static Torsion.
Comparison of the technological characteristics of the device to predicate and legally 7. 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
L&K BIOMED Co., Ltd. % Ms. Hee Kyeong Joo Room 1104, ACE High-End Tower 3 371-50, Gasan-dong, Geumcheon-gu, Seoul, 153-803 Republic of Korea
JUL 2 2 2011
Re: K103414
Trade 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: July 05, 2011 Received: July 08, 2011
Dear Ms. Joo:
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
3
Page 2 - Ms. Hee Kyeong Joo
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,
Mark N. Mollenhauer
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/1 description: The image shows the logo for L&K BIOMED. The logo is in black and white, with the text "L&K BIOMED" in a bold, sans-serif font. To the right of the text is a circular graphic made up of dashed lines. The text is the main focus of the logo, and the circular graphic is a secondary element.
103414
Indications for Use Statement
510(k) Number (if known): K103414
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 AND/OR
Over-The-Counter Use
ન્દ્રન
(Part 21 CER801 Subpart D)
(21 CER801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OED)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | K103914 |
|---|---|
| --------------- | --------- |
Page 10 / 49