(94 days)
Not Found
No
The provided text describes a mechanical spinal fixation system and its intended use. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies listed are mechanical tests.
Yes
The devices are described as "Posterior Cervical Fixation System[s]" intended to "provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine... and the thoracic spine". They are used to treat various medical conditions such as "traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions... tumors involving the cervical spine; and degenerative disease". These uses clearly fall under the definition of a therapeutic device.
No
The device is a spinal fixation system intended to provide immobilization and restore the integrity of the spinal column, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components (screws, rods, hooks, etc.) and describes an open surgical approach, indicating it is a physical implant system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant system designed to provide mechanical support and stabilization to the cervical and thoracic spine. This is a therapeutic intervention, not a diagnostic test performed on biological samples.
- Device Description: The device is described as a "top-loading, multiple component, posterior (cervicalthoracic) spinal fixation system" consisting of screws, rods, hooks, and accessories used in an open surgical approach. 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 treatment.
- Performance Studies: The performance studies listed (ASTM F 1717 and ASTM F 1798) are mechanical tests evaluating the structural integrity and performance of the implant under various loads, which is typical for surgical implants, not IVDs.
In summary, the CastleLoc-S Posterior Cervical Fixation System and LnK Posterior Cervical Fixation System are surgical implants used to stabilize the spine, not devices used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
CastleLoc-S Posterior Cervical Fixation System:
The CastleLoc-S Posterior Cervical Fixation System is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (TI-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Castelor Cervical Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System and PathLoc-C Posterior Cervical Fixation System via rod to rod connector and transitional rod.
LnK Posterior Cervical Fixation System:
The LnK Posterior Cervical Fixation System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The LnK Posterior Cervical Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion
The LnK Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System and PathLoc-C Posterior Cervical Fixation System via rod to rod connector and transitional rod.
Product codes (comma separated list FDA assigned to the subject device)
NKG, KWP, MNI
Device Description
The CastleLoc-S Posterior Cervical Fixation System and LnK Posterior Cervical Fixation System are a top-loading, multiple component, posterior (cervicalthoracic) spinal fixation system which consists of polyscrew, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, curved rod, transitional rod, set screw, hooks and accessories that can be used via an open surgical approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C1 to C7) and the thoracic spine (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)
Performance testing conducted:
- ASTM F 1717
- Static and Dynamic Compression Bending
- Static Torsion
- Static Tension
- ASTM F 1798
- Axial Gripping Capacity
- Torsional Gripping Capacity
- Transverse Moment
Key Results: Not Found
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
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
0
Image /page/0/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized representation of a human figure, composed of three overlapping profiles facing to the right. The profiles are rendered in a simple, abstract style, with flowing lines suggesting hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 3, 2016
L&K BIOMED Co., Ltd. % Ms. Yerim An RA Specialist L&K Biomed Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil Giheung-gu, Yongin-si, 446-916 KOREA
Re: K162136
Trade/Device Name: LnK Posterior Cervical Fixation System/CastleLoc-S Posterior Cervical Fixation System Regulatory Class: Unclassified Product Code: NKG, KWP, MNI Dated: October 5, 2016 Received: October 7, 2016
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 Parts 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/ResourcesforYou/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,
Vincent J. Devlin -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) K162136
Device Name
CastleLoc-S Posterior Cervical Fixation System LnK Posterior Cervical Fixation System
Indications for Use (Describe)
CastleLoc-S Posterior Cervical Fixation System:
The CastleLoc-S Posterior Cervical Fixation System is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (TI-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Castelor Cervical Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System and PathLoc-C Posterior Cervical Fixation System via rod to rod connector and transitional rod.
LnK Posterior Cervical Fixation System:
The LnK Posterior Cervical Fixation System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The LnK Posterior Cervical Fixation System is also intended to
restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion
The LnK Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System and PathLoc-C Posterior Cervical Fixation System via rod to rod connector and transitional rod.
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)
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
e-mail: yerim2706@gmail.com |
|----|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Yerim An |
| | Date prepared: | Nov. 1, 2016 |
Device Identification 2.
| Trade Name | CastleLoc-S Posterior Cervical Fixation System;
LnK Posterior Cervical Fixation System |
|---------------------|-------------------------------------------------------------------------------------------|
| Common Name | Spinal Fixation System |
| Product Code | NKG, KWP |
| Regulatory Class | Unclassified |
| Classification Name | Unclassified |
Purpose of 510(k) 3.
The L&K BIOMED Co.Ltd, here by submits this traditional 510(k): to request posterior cervical screw indications and to include new accessories and additional sizes of rods and partially screws in our previous LnK Posterior Cervical Fixation System and introduce CastleLoc-S Posterior Cervical Fixation System.
- Predicate or legally marketed devices which are substantially equivalent 4. Primary Predicate: OASYS® System (K151755) Additional Device: LnK Posterior Cervical Fixation System (K143278)
4
Description of the Device 5.
The CastleLoc-S Posterior Cervical Fixation System and LnK Posterior Cervical Fixation System are a top-loading, multiple component, posterior (cervicalthoracic) spinal fixation system which consists of polyscrew, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, curved rod, transitional rod, set screw, hooks and accessories 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 | |
| Hook | Ti-6Al-4V ELI | ASTM F136 |
| Set Screw | Ti-6Al-4V ELI | ASTM F136 |
| Accessories | Ti-6Al-4V ELI | ASTM F136 |
Any implant components other than the rods are not manufactured from cobalt chrome.
Indication for Use 6.
For CastleLoc-S Posterior Cervical Fixation System
The CastleLoc-S Posterior Cervical Fixation System is intended to provide immobilization and stabilization of spinal seqments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The CastleLoc-S Posterior Cervical Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion
The CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System and PathLoc-C Posterior Cervical Fixation System via rod to rod connector and transitional rod.
5
For LnK Posterior Cervical Fixation System
The LnK Posterior Cervical Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The LnK Posterior Cervical Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion
The LnK Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System and PathLoc-C Posterior Cervical Fixation System via rod to rod connector and transitional rod.
Comparison of the technological characteristics of the subject and 7. predicate devices
For CastleLoc-S Posterior Cervical Fixation System
The CastleLoc-S Posterior Cervical Fixation System is considered substantially equivalent to legally marketed devices OASYS system. They are similar in design, material, scientific technologies and indications for use.
| Applicant | L&K BIOMED Co.,Ltd. | Stryker |
|---|---|---|
| Device Name | CastleLoc-S Posterior Cervical Fixation | |
| System | OASYS System | |
| Subject Device | Primary Predicate Device | |
| 510K No. | K162136 | K151755 |
| Regulation No. | 888.3050 | 888.3050 |
| Product Code | NKG, KWP | NKG, KWP |
| Class | Unclassified | Unclassified |
| Material | Titanium alloy (ASTM F136) | |
| CoCr Alloy (ASTM F1537) | Titanium alloy, CP Titanium, Vitallium | |
| Sterile | Non-sterile | Non-sterile |
| Indication for use | The CastleLoc-S Posterior Cervical Fixation | |
| System is intended to provide immobilization | ||
| and stabilization of spinal segments as an | ||
| adjunct to fusion for the following acute and | ||
| chronic instabilities of the cervical spine (C1 to | ||
| C7) and the thoracic spine from T1-T3: | The Stryker Spine OASYS® System is | |
| intended to provide immobilization | ||
| and stabilization of spinal segments as an | ||
| adjunct to fusion for the | ||
| following acute and chronic instabilities of the | ||
| craniocervical junction, | ||
| the cervical spine (C1 to C7) and the thoracic |
6
| traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The CastleLoc-S Posterior Cervical Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion The CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System and PathLoc-C Posterior Cervical Fixation System via rod to rod connector and transitional rod. | spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Stryker Spine OASYS® System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Stryker Spine OASYS® System can be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors and transition rods. The Stryker Spine OASYS® System can also be linked to the polyaxial screws of the Xia® II and Xia® 3 Systems via |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
For LnK Posterior Cervical Fixation System
The LnK Posterior Cervical Fixation System is considered substantially equivalent to legally marketed devices OASYS system. They are similar in design, material,
| Applicant | L&K BIOMED Co.,Ltd. | Stryker |
|---|---|---|
| Device Name | LnK Posterior Cervical Fixation System | OASYS System |
| Subject Device | Primary Predicate Device | |
| 510K No. | K162136 | K151755 |
| Regulation No. | 888.3050 | 888.3050 |
| Product Code | NKG, KWP | NKG, KWP |
| Class | Unclassified | Unclassified |
| Material | Titanium alloy (ASTM F136) | |
| CoCr Alloy (ASTM F1537) | Titanium alloy, CP Titanium, Vitallium | |
| Sterile | Non-sterile | Non-sterile |
| Indication for use | The LnK Posterior Cervical Fixation System is intended to provide immobilization and | |
| stabilization of spinal segments as an adjunct | ||
| to fusion for the following acute and chronic | ||
| instabilities of the cervical spine (C1 to C7) and | The Stryker Spine OASYS® System is | |
| intended to provide immobilization | ||
| and stabilization of spinal segments as an | ||
| adjunct to fusion for the | ||
| following acute and chronic instabilities of the |
scientific technologies and indications for use.
7
| the thoracic spine from T1-T3: traumatic spinal
fractures and/or traumatic dislocations;
instability or deformity; failed previous fusions
(e.g., pseudarthrosis); tumors involving the
cervical spine; and degenerative disease,
including intractable radiculopathy and/or
myelopathy, neck and/or arm pain of
discogenic origin as confirmed by radiographic
studies, and degenerative disease of the
facets with instability. The CastleLoc-S
Posterior Cervical Fixation System is also
intended to restore the integrity of the spinal
column even in the absence of fusion for a
limited time period in patients with advanced
stage tumors involving the cervical spine in
whom life expectancy is of insufficient duration
to permit achievement of fusion
The LnK Posterior Cervical Fixation System
can be linked to the LnK Spinal Fixation
System and PathLoc-C Posterior Cervical
Fixation System via rod to rod connector and
transitional rod. | craniocervical junction,
the cervical spine (C1 to C7) and the thoracic
spine (T1-T3): traumatic
spinal fractures and/or traumatic dislocations;
instability or deformity;
failed previous fusions (e.g. pseudoarthrosis);
tumors involving the
cervical/thoracic spine; and degenerative
disease, including
intractable radiculopathy and/or myelopathy,
neck and/or arm pain
of discogenic origin as confirmed by
radiographic studies, and
degenerative disease of the facets with
instability.
The Stryker Spine OASYS® System is also
intended to restore the
integrity of the spinal column even in the
absence of fusion for a
limited time period in patients with advanced
stage tumors involving
the cervical spine in whom life expectancy is of
insufficient duration to
permit achievement of fusion.
The Stryker Spine OASYS® System can be
linked to the Xia® System,
SR90D System and Xia® 4.5 Spinal System
via the rod-to-rod
connectors and transition rods.
The Stryker Spine OASYS® System can also
be linked to the polyaxial
screws of the Xia® II and Xia® 3 Systems via
the saddle connector. |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Performance Testing 8.
- (1) ASTM F 1717
- Static and Dynamic Compression Bending ●
- Static Torsion .
- Static Tension .
- (2) ASTM F 1798
- Axial Gripping Capacity .
- Torsional Gripping Capacity ●
- Transverse Moment .
Conclusion 9.
The CastleLoc-S Posterior Cervical Fixation System and LnK Posterior Cervical Fixation System are substantially equivalent to legally marketed predicates.