(53 days)
Not Found
No
The device description and intended use clearly define a mechanical implant system for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended for "immobilization and stabilization of the spine as an adjunct to fusions," which aligns with the definition of a therapeutic device designed to treat medical conditions.
No
Explanation: The device is an implantable surgical system (plate and screws) used for stabilization and immobilization of the cervical spine as an adjunct to fusions. It is a treatment device, not one that identifies or characterizes a disease or condition.
No
The device description explicitly states it is composed of plates and screws made from titanium alloy, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the LEXUS Anterior Cervical Plate System is for "anterior screw fixation to the cervical spine (C2-C7)" and is used for "immobilization and stabilization of the spine as an adjunct to fusions". This describes a surgical implant used directly on the patient's body.
- Device Description: The device is described as being composed of "plates and screws" made from titanium alloy. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The LEXUS Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:
- degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis,
- trauma (i.e. fractures or dislocations),
- tumors.
- deformity (defined as kyphosis, lordosis or scoliosis),
- pseudarthrosis,
- failed previous fusion,
- spinal stenosis.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The LEXUS Anterior Cervical Plate System is composed of plates and screws which are made from titanium alloy Ti-6A1-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates range in length to accommodate one, two, three, and four level procedures. The screws in the LEXUS Anterior Cervical Plate System are 3.5mm and 4.0mm diameter bone screws. They are fixed self-tapping, variable self-tapping, fixed self-drilling, variable self-drilling and are available in lengths ranging from 12 to 20mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7)
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)
Static compression bending, tension, torsion and dynamic compression bending were performed according to ASTM F1717 on a worst-case, cervical plate construct. The mechanical test results demonstrated that the LEXUS Anterior Cervical Plate System performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K061002, K031276, K994239, K030327
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
KII 3509
JAN 2 0 2012 L&K BIOME
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 Korea | ||
| Phone. 82-2-2624-1471 | ||
| FAX. 82-2-2624-1477 | ||
| Contact Person: | Hee Kyeong Joo | |
| Prepared Date | November 24, 2011 |
2. Device Identification
| Trade Name | LEXUS Anterior Cervical Plate System |
|---|---|
| Common Name | Anterior Cervical Plate |
| Classification Name | Spinal Intervertebral Body Fixation Orthosis |
| Regulation Number | 21 CFR 888.3060 |
| Product Code | KWQ |
| Device Classification | Class II |
3. Identification of Legally Marketed Devices
- U&I Corporation: Maxima™ Anterior Cervical Plate System (K061002) .
- . Synthes: Synthes Anterior Cervical Locking Plate(ACLP) System (K031276)
- Medtronic: ZEPHIR™ Anterior Cervical Plate System(K994239, K030327) .
4. Description of the Device
The LEXUS Anterior Cervical Plate System is composed of plates and screws which are made from titanium alloy Ti-6A1-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates range in length to accommodate one, two, three, and four level procedures. The screws in the LEXUS Anterior Cervical Plate System are 3.5mm and 4.0mm diameter bone screws. They are fixed self-tapping, variable selftapping, fixed self-drilling, variable self-drilling and are available in lengths ranging from 12 to 20mm.
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KI13509
Image /page/1/Picture/1 description: The image shows the logo for L&K BIOMED. The logo consists of the text "L&K BIOMED" in a bold, sans-serif font. Above the text is a graphic element that appears to be a stylized circle or ring made up of smaller circles or dots. The overall design is simple and modern.
5. Intended use
The LEXUS Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:
- degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis, •
- trauma (i.e. fractures or dislocations), .
- tumors. .
- . deformity (defined as kyphosis, lordosis or scoliosis),
- pseudarthrosis, .
- failed previous fusion, t
- spinal stenosis.
6. Comparison of the Technology Characteristics
The LEXUS Anterior Cervical Plate System shares technological characteristics similar to the predicate devices. These characteristics include similar design, the same materials, substantially equivalent performance characteristics and the same intended use.
7. Discussion of the Non-Clinical Testing
Static compression bending, tension, torsion and dynamic compression bending were performed according to ASTM F1717 on a worst-case, cervical plate construct. The mechanical test results demonstrated that the LEXUS Anterior Cervical Plate System performs as well as the predicate device.
8. Conclusion
The LEXUS Anterior Cervical Plate System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a triple-stranded helix representing the interconnectedness of health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002
JAN 2 0 2012
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
Re: K113509
Trade/Device Name: LEXUS Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 24, 2011 Received: November 28, 2011
Dear Ms. Hee Kyeong 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 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
3
Page 2 - Ms. Hee Kyeong Joo
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
Sincerely yours,
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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Image /page/4/Picture/1 description: The image shows the logo for L&K BIOMED. The logo consists of the text "L&K BIOMED" in bold, black letters. Above the text is a smaller line of text that is difficult to read. To the right of the text is a circular graphic that is also in black.
Indications for Use Statement
510(k) Number (if known): K113509
Device Name: LEXUS Anterior Cervical Plate System
Indications For Use:
The LEXUS Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:
- degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis, י
- trauma (i.e. fractures or dislocations), ,
- tumors. .
- deformity (defined as kyphosis, lordosis or scoliosis), .
- pseudarthrosis, .
- failed previous fusion, .
- spinal stenosis.
| Prescription Use | √ |
|---|---|
| (Part 21 CER801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (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 | K113509 |
|---|---|
| --------------- | --------- |
LEXUS Anterior Cervical Plate System
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