(149 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and components of a spinal fixation system, with no mention of software, algorithms, or any form of data processing that would suggest AI/ML.
Yes
The device is used to treat specific medical conditions, such as degenerative disc disease, spondylolisthesis, fractures, and deformities, by providing immobilization and stabilization of spinal segments, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a spinal fixation system, which is a surgical implant used to stabilize the spine and aid in fusion. Its purpose is mechanical support and stabilization, not to diagnose a condition.
No
The device description explicitly lists physical components made of titanium and CoCrMo alloys (screws, set screws, rods, crosslink, Hook, and connectors), indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for stabilizing the spine in skeletally mature patients with various spinal conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like screws, rods, and hooks made of specific alloys. This aligns with a surgical implant, not a device used to examine samples from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information based on in vitro testing.
Therefore, the LnK Spinal Fixation System is a medical device intended for surgical implantation and stabilization, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
LnK Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation system T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative dis disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis); tumor, stenosis; and failed previous fusion (pseudoarthrosis).
The LnK Spinal Fixation System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the LnK Spinal Fixation System is intended to provide immobilization 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNH, MNI, KWP, KWQ
Device Description
This system is comprised of screws, set screws, rods, crosslink, Hook and connectors. The components of this system are manufactured by Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 8.5mm diameters with lengths ranging from 20-150mm. The purpose of this submission is to add Hooks to this system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1-S2/ilium, T8-L5, L5-S1 vertebra, L3 to sacrum, thoracic, lumbar and sacral spine
Indicated Patient Age Range
skeletally mature patients
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)
Non-Clinical Performance and Conclusions:
Bench testing results demonstrate that LnK Spinal Fixation system performs equivalently to the predicates in static compression bending, static tension, static torsion, dynamic compression bending (in accordance with ASTM F1717-10) and gripping-push down (in accordance with ASTM F1798). Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this 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.
K120270, K071373, K083393, K091291
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
§ 888.3070 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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a human face in profile, with three overlapping profiles to represent the department's focus on health, human services, and the well-being of the nation. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 22, 2015
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: K143363
Trade/Device Name: LnK Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP, KWQ Dated: March 19, 2015 Received: March 23, 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 (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
1
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" (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,
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
510(k) Number (if known) K143363
Device Name LnK Spinal Fixation System
Indications for Use (Describe)
LnK Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation system T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative dis disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis); tumor, stenosis; and failed previous fusion (pseudoarthrosis).
The LnK Spinal Fixation System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the LnK Spinal Fixation System is intended to provide immobilization 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
March 19, 2015 Date prepared:
Device Identification 2.
| Trade Name | LnK Spinal Fixation System |
|---|---|
| Common Name | Spinal Fixation Appliances |
| Product Code | NKB, KWP, KWQ, MNH, MNI |
| Classification Name | Class III |
| Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050 | |
| Pedicle Screw Spinal System, 21 CFR §888.3070 |
3. Predicate or legally marketed devices which are substantially equivalent
-
- Primary- L&K Biomed: VENUS Spinal System K120270
4. Description of the Device
This system is comprised of screws, set screws, rods, crosslink, Hook and connectors. The components of this system are manufactured by Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 8.5mm diameters with lengths ranging from 20-150mm. The purpose of this submission is to add Hooks to this system.
4
5. Indications for Use
LnK Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use:
- degenerative disc disease (defined as discogenic back pain with degeneration of the disc ● confirmed by history and radiographic studies);
- spondylolisthesis; ●
- trauma (i.e., fracture or dislocation);
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
- tumor:
- stenosis, and
- failed previous fusion (pseudoarthrosis)
The LnK Spinal Fixation System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the LnK Spinal Fixation System is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).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
| Submitter | L&K BIOMED | Stryker |
|---|---|---|
| Device Name | LnK Spinal Fixation system | Xia 3 Spinal System |
| 510K # | K071373(T), K083393 (T),K091291 (S) | |
| Regulation | ||
| Number | 21 CFR 888.3050, 21 CFR 888.3060, | |
| 21 CFR 888.3070 | 21 CFR 888.3050, 21 CFR 888.3060, 21 CFR 888.3070 | |
| Class | III | III |
| Product | ||
| Code | MNI,MNH,KWQ,KWP,NKB | MNI,MNH,KWQ,KWP,NKB |
| Material | ASTM F136, ASTM F1537 | ASTM F136, ASTM F1537 |
| Sterility | Non-sterile | Non-sterile |
| Rod | Dia: 5.0/5.5/6.0mm | |
| Length:40~600mm | Dia:5.5 mm Length:30-600mm | |
| Screw | Dia:4.0~8.5mm Length:20-150mm | Dia: 4.0.-10.5mm Length: 20-100mm |
| Hooks | Ramped Hook - 6.0 Rod(Narrow, | |
| Standard, Wide) | ||
| General Hook - 6.0 Rod(Narrow, | ||
| Standard, Wide) | ||
| Pedicle Hook - 6.0 Rod(Narrow, | ||
| Standard, Wide) | ||
| Angled Hook - 6.0 Rod(Right, Left) | ||
| Offset Hook - 6.0 Rod(Right, Left) | Laminar Hook | |
| (Small Medium Large, Extended Body, Offset), (Narrow Blade, | ||
| Standard Blade) | ||
| Thoracic Laminar Hook (Small Medium Large, Extended Body, | ||
| Offset) | ||
| Offset Hook (Right, Left) | ||
| Pedicle Hook (Small, Medium, Large) | ||
| Transverse Process Hook (Right, Left) | ||
| Indication | LnK Spinal Fixation System is non- | The Stryker Spine XIA® 3 Spinal System is intended for use in the |
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Image /page/5/Picture/0 description: The image provides information on cervical and noncervical spinal fixation devices. Cervical spinal fixation devices are intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). The LnK Spinal Fixation System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra. The XIA® 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients.
The LnK Spinal Fixation 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. Performance Data
Non-Clinical Performance and Conclusions:
Bench testing results demonstrate that LnK Spinal Fixation system performs equivalently to the predicates in static compression bending, static tension, static torsion, dynamic compression bending (in accordance with ASTM F1717-10) and gripping-push down (in accordance with ASTM F1798). Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
8. Conclusion
The LnK Spinal Fixation System is substantially equivalent to the predicate device referenced above.