(111 days)
Not Found
No
The summary describes a passive implantable device (lumbar interbody fusion cage) made of PEEK and Tantalum. There is no mention of software, algorithms, image processing, AI, ML, or any computational components. The performance studies are mechanical tests of the device's structural integrity.
Yes.
This device is designed to aid in spinal fixation and address degenerative disc disease, which involves treating a medical condition.
No.
This device is an implantable intervertebral body fusion cage intended for spinal fixation, not for diagnosing medical conditions.
No
The device description clearly states it is a physical intervertebral body fixation device made from PEEK-OPTIMA® LT1 and Tantalum, available in various sizes and shapes for surgical implantation. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the LnK Lumbar Interbody Fusion Cage System is an "intervertebral body fixation device" intended for use as an aid in spinal fixation. It is a physical implant made of PEEK and Tantalum, designed to be surgically placed in the spine.
- Intended Use: The intended use is for "intervertebral body fusion procedures" in patients with degenerative disc disease. This is a surgical procedure involving the implantation of a device, not a diagnostic test performed on a sample.
The information provided describes a surgical implant used for spinal fusion, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
LnK Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. LnK Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The LnK Lumbar Interbody Fusion Cage System is intervertebral body fixation devices intended for use as an aid in spinal fixation. This system is fabricated and manufactured from PEEK-OPTIMA® LT1 as described by ASTM F2026. The Tantalum marker used for this product is made to the voluntary standard of ASTM F560. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. LnK Lumbar Interbody Fusion Cage System Implants are supplied as sterile or non-sterile.
The LnK PLIF PEEK Cages are to be implanted via posterior approach. These devices are placed two implants on each side of the interbody space (right and left).
The LnK T-PLIF PEEK Cages which is used in transforaminal posterior lumbar interbody fusion technique. However, this kind of cage is to be implanted only one implant on interbody space.
The LnK TLIF PEEK Cages are a "banana" shaped. Implants are dedicated to transforaminal approach. TLIF technique involves placing only one bone graft spacer in the middle of the interbody space, without retraction of the spinal nerves.
The LnK ALIF PEEK Cages are to be implanted via anterior approach.
The LnK DLIF PEEK Cages are to be implanted via direct lateral interbody fusion approach. LnK DLIF PEEK Cage can be used in an open approach and a percutaneous approach with MIS instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1
Indicated Patient Age Range
skeletally mature patients
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)
Mechanical performance of additional components is same with predicated (K121096). Additional sizes are not worst case. Therefore, We substitute mechanical test data of additional components of LnK Lumbar Interbody Fusion Cage System with it of LnK Lumbar Interbody Fusion Cage System(K121096).
The LnK Lumbar Interbody Fusion Cage System was tested according to the ASTM F 2077, specifically, Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing, Expulsion Testing and Static Subsidence testing under Axial Compression, per ASTM F 2267.
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2015
L&K BIOMED Co., Ltd Ms. Yerim An RA Specialist #201, 202 16-25, Dongaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si Gyeonggi-do, 446-916 Republic of Korea
Re: K151140
Trade/Device Name: LnK Lumbar Interbody Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 17, 2015 Received: July 20, 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
1
Page 2 - Ms. Yerim An
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 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 Statement
510(k) Number (if known): K151140 Device Name: LnK Lumbar Interbody Fusion Cage System
Indications For Use:
LnK Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. LnK Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
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)
3
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: | Aug. 13, 2015 |
2. Device Identification
| Trade Name | LnK Lumbar Interbody Fusion Cage System |
|---|---|
| Common Name | Intervertebral Body Fusion Device |
| Product Code | MAX |
| Classification Name | Intervertebral body fusion device (888.3080) |
3. Predicate or legally marketed devices which are substantially equivalent
The design feature and indications for use for the subject LnK Lumbar Interbody Fusion Cage System is substantially equivalent to the following predicates:
- . Primary Predicate: LnK Lumbar Interbody Fusion Cage System L&K BIOMED Co., Ltd (K121096)
- . Additional Predicate: LnK Lumbar Interbody Fusion Cage System_ L&K BIOMED Co., Ltd (K110783)
Description of the Device 4.
The LnK Lumbar Interbody Fusion Cage System is intervertebral body fixation devices intended for use as an aid in spinal fixation. This system is fabricated and manufactured from PEEK-OPTIMA® LT1 as described by ASTM F2026. The Tantalum marker used for this product is made to the voluntary standard of ASTM F560. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. LnK Lumbar Interbody Fusion Cage System Implants
4
are supplied as sterile or non-sterile.
The LnK PLIF PEEK Cages are to be implanted via posterior approach. These devices are placed two implants on each side of the interbody space (right and left).
The LnK T-PLIF PEEK Cages which is used in transforaminal posterior lumbar interbody fusion technique. However, this kind of cage is to be implanted only one implant on interbody space.
The LnK TLIF PEEK Cages are a "banana" shaped. Implants are dedicated to transforaminal approach. TLIF technique involves placing only one bone graft spacer in the middle of the interbody space, without retraction of the spinal nerves.
The LnK ALIF PEEK Cages are to be implanted via anterior approach.
The LnK DLIF PEEK Cages are to be implanted via direct lateral interbody fusion approach. LnK DLIF PEEK Cage can be used in an open approach and a percutaneous approach with MIS instrumentation.
5. Indication for use
LnK Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. LnK Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
5
| No | Item | LnK Lumbar Interbody Fusion | LnK Lumbar Interbody Fusion |
|---|---|---|---|
| Cage System | Cage System (Predicate) | ||
| 1 | Manufacturer | L&K BIOMED Co., Ltd. | L&K BIOMED Co., Ltd. |
| 2 | Material | PEEK and Tantalum | PEEK and Tantalum |
| 3 | 510(K) Number | K121096 | |
| 4 | Product Code | MAX | MAX |
| 5 | Class | ClassII | ClassII |
| 6 | Intended Use | LnK Lumbar Interbody | |
| Fusion Cage System is | |||
| indicated for intervertebral | |||
| body fusion procedures in | |||
| skeletally mature patients with | |||
| degenerative disc disease | |||
| (DDD) at one or two | |||
| contiguous levels from L2-S1. | |||
| DDD is defined as discogenic | |||
| back pain with degeneration | |||
| of the disc confirmed by | |||
| patient history and | |||
| radiographic studies. These | |||
| DDD patients may also have | |||
| up to Grade 1 | |||
| spondylolisthesis or | |||
| retrolisthesis at the involved | |||
| level(s).This device is to be | |||
| used with autogenous bone | |||
| graft. LnK Lumbar Interbody | |||
| Fusion Cage System is to be | |||
| used with supplemental | |||
| fixation. Patients should have | |||
| at least six (6) months of non- | |||
| operative treatment prior to | |||
| treatment with an | |||
| intervertebral cage | LnK Lumbar Interbody | ||
| Fusion Cage System is | |||
| indicated for intervertebral | |||
| body fusion procedures in | |||
| skeletally mature patients with | |||
| degenerative disc disease | |||
| (DDD) at one or two | |||
| contiguous levels from L2-S1. | |||
| DDD is defined as discogenic | |||
| back pain with degeneration | |||
| of the disc confirmed by | |||
| patient history and | |||
| radiographic studies. These | |||
| DDD patients may also have | |||
| up to Grade 1 | |||
| spondylolisthesis or | |||
| retrolisthesis at the involved | |||
| level(s).This device is to be | |||
| used with autogenous bone | |||
| graft. LnK Lumbar Interbody | |||
| Fusion Cage System is to be | |||
| used with supplemental | |||
| fixation. Patients should have | |||
| at least six (6) months of non- | |||
| operative treatment prior to | |||
| treatment with an | |||
| intervertebral cage |
Comparison of the technology characteristics of the device to predicate and 6. legally marketed devices
7. Performance Data
Mechanical performance of additional components is same with predicated (K121096). Additional sizes are not worst case. Therefore, We substitute mechanical test data of additional components of LnK Lumbar Interbody Fusion Cage System with it of LnK Lumbar Interbody Fusion Cage System(K121096).
6
The LnK Lumbar Interbody Fusion Cage System was tested according to the ASTM F 2077, specifically, Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing, Expulsion Testing and Static Subsidence testing under Axial Compression, per ASTM F 2267.
Conclusion 8.
The additional components of LnK Lumbar Interbody Fusion Cage System are substantially equivalent to the device.