(230 days)
Not Found
No
The device description focuses on the mechanical components (plates, screws, lockers) and their material, intended use for spinal fixation, and performance testing based on mechanical standards. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is intended for "immobilization and stabilization of the spine as an adjunct to fusions in patients" with various spinal conditions, indicating it is used to treat or manage disease.
No
The device is an Anterior Cervical Plate System intended for surgical fixation and stabilization of the spine as an adjunct to fusions. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is composed of plates, screws, and lockers made from titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that the CastleLoc-P Anterior Cervical Plate System is composed of plates, screws, and lockers made from titanium alloy. These are implanted devices used for surgical fixation of the cervical spine.
- Intended Use: The intended use is for "anterior screw fixation to the cervical spine (C2-C7)" as an "adjunct to fusions." This is a surgical procedure involving the implantation of a device, not the analysis of a biological specimen.
The information provided describes a surgical implant, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The CastleLoc-P 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),
- failed previous fusion (pseudoarthrosis) .
- spinal stenosis. .
Product codes (comma separated list FDA assigned to the subject device)
KWO
Device Description
The CastleLoc-P Anterior Cervical Plate System is composed of plates, screws and lockers 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 are offered in one-level, two-level, three-level, four-level fusion configurations (19~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are selftapping and self-drilling threaded. This device is provided as non-sterile.
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
Prescription Use
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. These data demonstrate substantial equivalence in terms of performance bench testing.
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.
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
Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces or heads. The symbol is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 1, 2015
L&K Biomed Company, Limited Ms. Yerim An Regulatory Affairs Specialist #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si Gyeonggi-do, 446-916 Republic of Korea
Re: K143271
Trade/Device Name: CastleLoc-P Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: June 4, 2015 Received: June 5, 2015
Dear Ms. An:
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
1
Page 2 - Ms. Yerim An
(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number (if known): K143271 Device Name: CastleLoc-P Anterior Cervical Plate System
Indications For Use:
The CastleLoc-P 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),
- failed previous fusion (pseudoarthrosis) .
- 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 (CDRH)
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K143271
3
K143271 - Page 1 of 2
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
| 1. | Submitter: | Gook Jin Kang
L&K BIOMED Co., Ltd.
#201, 202 16-25, Dongbaekjungang-ro 16 beon-gil
Giheung-gu, Yongin-si, Gyeonggi-do, 446-916,
Korea
Phone. 82-2-6717-1985
FAX .82-2-6717-1989 |
|----|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Yerim An |
| | Date prepared: | June, 05, 2015 |
| 2. | Device Identification | |
| | Trade Name | CastleLoc-P Anterior Cervical Plate System |
| | Common Name | Anterior Cervical Plate |
| | Product Code | KWQ |
| | Classification Name | Spinal Intervertebral Body Fixation Orthosis
(21 CFR888.3060) |
| | Classification | Class II |
3. Primary Predicate or legally marketed devices which are substantially equivalent
■ Primary predicate device : L&K Biomed_LnK Anterior Cervical Plate System (K113509)
4. Description of the Device
The CastleLoc-P Anterior Cervical Plate System is composed of plates, screws and lockers 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 are offered in one-level, two-level, three-level, four-level fusion configurations (19~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are selftapping and self-drilling threaded. This device is provided as non-sterile.
4
5. Intended use
The CastleLoc-P 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),
- failed previous fusion (pseudoarthrosis)
- spinal stenosis. .
Comparison of the technology characteristics of the device to primary predicate 6. and legally marketed devices
There are no significant differences between the LnK Anterior Cervical Plate System and CastleLoc-P Anterior Cervical Plate System and other systems currently being marketed which would not adversely affect the use of the product. It is substantially equivalent to these other devices in design, function and intended use.
7. Performance Data
Static compression bending, tension, torsion and dynamic compression bending were performed according to ASTM F1717 on a worst-case, cervical plate construct. These data demonstrate substantial equivalence in terms of performance bench testing.
8. Conclusion
The CastleLoc-P Anterior Cervical Plate System is substantially equivalent to the devices referenced above and is therefore safe and effective for its intended use.