(257 days)
Not Found
No
The summary describes a mechanical spinal fixation system with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a fixation system used to stabilize the spine, which is a therapeutic intervention for conditions like DDD, spondylolisthesis, and fractures.
No
The device is a fixation system used to stabilize the spine as an adjunct to fusion; it treats conditions rather than diagnosing them.
No
The device description clearly states it is a "multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyscrew, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, curved rod, transitional rod, set screw and hooks". These are physical implants and surgical components, not software.
Based on the provided information, 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 and Intended Use: The description clearly states that this is a "posterior (cervical-thoracic) spinal fixation system" consisting of implants like screws, rods, and hooks. Its intended use is to provide "stabilization as an adjunct to fusion" in the spine for various conditions.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens from a patient. Its function is purely mechanical and surgical.
Therefore, the LnK Posterior Cervical Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LnK Posterior 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 following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-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 (comma separated list FDA assigned to the subject device)
KWP, MNI
Device Description
The LnK Posterior Cervical Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyscrew, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, curved rod, transitional rod, set screw and hooks that can be used via an open surgical approach.
Materials:
Cervical Screw: Ti-6Al-4V ELI (ASTM F136)
Rod: Ti-6Al-4V ELI (ASTM F136), Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537)
Hook: Ti-6Al-4V ELI (ASTM F136)
Set Screw: Ti-6Al-4V ELI (ASTM F136)
Any implant components other than the rods are not manufactured from cobalt chrome.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical/upper thoracic (CI-T3) spine, T1-T3
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 testing was performed per ASTM F1717.
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(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" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right. The profiles are connected and flow together, creating a sense of unity and collaboration.
July 29, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
L&K BIOMED Company, Limited Ms. Yerim An #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si Gyeonggi-do, 446-916 Republic of Korea
Re: K143278
Trade/Device Name: LnK Posterior Cervical Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI Dated: July 3, 2015 Received: July 6, 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 (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143278
Device Name
LnK Posterior Cervical Fixation System
Indications for Use (Describe)
The LnK Posterior 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 following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-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.
| Type of Use (Select one or both, as applicable) | ||||
|---|---|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.
#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: | July 24, 2015 |
Device Identification 2.
| Trade Name | LnK Posterior Cervical Fixation System |
|---|---|
| Common Name | Spinal Fixation System |
| Product Code | KWP, MNI |
| Regulatory Class | II |
| Classification Name | 21CFR888.3050 Spinal Interlaminal Fixation Orthosis |
| 21CFR888.3070 Pedicle Screw Spinal System |
3. Purpose of 510(k)
The L&K BIOMED Co.Ltd, here by submits this traditional 510(k): device modification to request a modification for our LnK Posterior Cervical Fixation System. The modifications are adding sizes and additional components.
4. Primary Predicate or legally marketed devices which are substantially equivalent
- Primary predicate: L&K BIOMED Co.,Ltd. / LnK Posterior Cervical Fixation System (K120879)
5. Description of the Device
The LnK Posterior Cervical Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyscrew, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, curved rod, transitional rod, set screw and hooks that can be used via an open surgical approach.
Materials:
| Product | Material | Standard |
|---|---|---|
| Cervical Screw | Ti-6Al-4V ELI | ASTM F136 |
| Rod | Ti-6Al-4V ELI | ASTM F136 |
| Cobalt-28Chromium-6Molybdenum-4Vanadium ELI | ASTM F1537 |
4
| Hook | Ti-6Al-4V ELI | ASTM F136 |
|---|---|---|
| Set Screw | Ti-6Al-4V ELI | ASTM F136 |
Any implant components other than the rods are not manufactured from cobalt chrome.
6. Indication for use
The LnK Posterior 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 (CI-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.
7. Comparison of the technological characteristics of the subject and predicate devices
The LnK Posterior Cervical Fixation System is considered substantially equivalent to other legally marketed devices. They are similar in design, material, and indications for use.
| No | Item | LnK Posterior Cervical Fixation System | LnK Posterior Cervical Fixation System (Primary Predicate) |
|---|---|---|---|
| 1 | Manufacturer | L&K BIOMED Co., Ltd. | L&K BIOMED Co., Ltd. |
| 2 | Material | Ti-6Al-4V ELI and CoCrMo alloy | Ti-6Al-4V ELI |
| 3 | 510(K) number | K143278 | K120879 |
| 4 | Product Code | MNI, KWP | MNI, KWP |
| 5 | Class | ClassIl | ClassIl |
| 6 | Intended Use | The LnK Posterior 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) | The LnK Posterior 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) |
5
| 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 (CI-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. | 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 (CI-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. |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
8. Performance Data
Static compression bending testing was performed per ASTM F1717.
9. Conclusion
The LnK Posterior Cervical Fixation System is substantially equivalent to legally marketed predicates.