(110 days)
Not Found
No
The document describes a physical implantable device (lumbar interbody fusion cage system) made of PEEK material. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on mechanical testing and finite element analysis, not algorithmic performance.
Yes
The device is used for intervertebral body fusion procedures for degenerative disc disease, which aims to treat a medical condition.
No
This device is an intervertebral body fixation device intended for use as an aid in spinal fixation during fusion procedures, not for diagnostic purposes.
No
The device description clearly states it is a physical intervertebral body fixation device fabricated from PEEK-OPTIMA® LT1 and Tantalum, available in various sizes and shapes for surgical implantation. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "intervertebral body fusion procedures" and is an "aid in spinal fixation." This describes a surgical implant used directly within the body for structural support and fusion.
- Device Description: The description details the physical characteristics of the implant (material, shape, sizes, teeth) and how it is surgically implanted (posterior, transforaminal, anterior, lateral approaches).
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples or diagnostic purposes.
Therefore, the LnK Lumbar Interbody Fusion Cage System is a surgical implant, not an In Vitro Diagnostic device.
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. LtK Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative 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 single-use devices. They have to be used in a healthcare setting or a hospital. The LnK PLIF PEEK Cages are to be implanted via posterior approach. Two PLIF PEEK cages are placed 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. One T-PLIF cage is implanted in 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 (LnK LLIF PEEK Cages/LnK Lateral PEEK Cages) are to be implanted via direct lateral interbody fusion approach. LnK DLIF PEEK Cage (LnK LLIF PEEK Cage/LnK Lateral PEEK Cage) can be used in an open approach and a percutaneous approach with MIS instrumentation. The LnK ATP PEEK Cages are to be implanted via anterior lateral approach.
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
healthcare setting or a hospital.
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 the predicate device (K151140). We performed finite element analysis to demonstrate that the additional components do not introduce a new worst case in terms of mechanical performance. Therefore, we leveraged the mechanical test data of the primary predicate (LnK Lumbar Interbody Fusion Cage System, K151140) to demonstrate the performance of the subject components. It is widely known that gamma sterilization does not affect the performance of the device. Therefore, only mechanical test data of non-sterilized cages was provided. The LnK Lumbar Interbody Fusion Cage System was tested according to the relevant standards, specifically, Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing per ASTM F2077, Static Subsidence testing under Axial Compression, per ASTM F2267, and Expulsion Testing and.
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
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L&K BIOMED Co., Ltd. Jihyeon Seo RA Associate #201, 202, 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, 17015 Korea
Re: K181380
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: August 23, 2018 Received: August 23, 2018
Dear Ms. Seo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
September 11, 2018
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter -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) K181380
Device Name
LnK Lumbar Interbody Fusion Cage System
Indications for Use (Describe)
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. LtK Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
| 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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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, 17015, Korea
Phone. 82-2-6717-1983
FAX .82-2-6717-1949 |
|----|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Jihyeon Seo |
| | Date prepared: | August 28, 2018 |
2. Device Identification
| Trade Name | LnK Lumbar Interbody Fusion Cage System |
|---|---|
| Common Name | Lumbar Interbody Fusion Cage System |
| Product Code | MAX |
| Regulatory Class | II |
| Classification Name | Intervertebral body fusion device (21 CFR 888.3080) |
Predicate or legally marketed devices which are substantially equivalent 3.
The design feature and indications for use for the subject LnK Lumbar Interbody Fusion Cage System is substantially equivalent to the following predicates:
- Unmodified device (predicate): LnK Lumbar Interbody Fusion Cage System (K151140) ●
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 are single-use devices. They have to be used in a healthcare setting or a hospital.
4
The LnK PLIF PEEK Cages are to be implanted via posterior approach. Two PLIF PEEK cages are placed 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. One T-PLIF cage is implanted in 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 (LnK LLIF PEEK Cages/LnK Lateral PEEK Cages) are to be implanted via direct lateral interbody fusion approach. LnK DLIF PEEK Cage (LnK LLIF PEEK Cage/LnK Lateral PEEK Cage) can be used in an open approach and a percutaneous approach with MIS instrumentation.
The LnK ATP PEEK Cages are to be implanted via anterior lateral approach.
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 | Subject device | Predicate device |
|---|---|---|---|
| LnK Lumbar Interbody Fusion | |||
| Cage System | LnK Lumbar Interbody Fusion | ||
| Cage System | |||
| 1 | Manufacturer | L&K BIOMED Co., Ltd. | L&K BIOMED Co., Ltd. |
| 2 | Material | PEEK and Tantalum | PEEK and Tantalum |
| 3 | 510(K) Number | K151140 | |
| 4 | Product Code | MAX | MAX |
| 5 | Class | Class II | Class II |
| 6 | Sterility | Non-sterile, Sterile | Non-sterile |
| 7 | 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. |
6. Comparison of the technology characteristics of the device to predicate and legally marketed devices
6
| Current | Previous | |
|---|---|---|
| PLIF, T-PLIF, TLIF, ALIF, DLIF, ATP PEEK Cage | PLIF, T-PLIF, TLIF, ALIF, DLIF Cage | |
| Width: 11~65mm | ||
| Length: 11~33mm | ||
| Height: 6~19mm | ||
| Lordosis: 0°~ 30° | Width: 11~65mm | |
| Length: 11~32mm | ||
| Height: 6~19mm | ||
| Lordosis : 0°~ 14° |
7. Performance Data
Mechanical performance of additional components is same with the predicate device (K151140). We performed finite element analysis to demonstrate that the additional components do not introduce a new worst case in terms of mechanical performance. Therefore, we leveraged the mechanical test data of the primary predicate (LnK Lumbar Interbody Fusion Cage System, K151140) to demonstrate the performance of the subject components. It is widely known that gamma sterilization does not affect the performance of the device. Therefore, only mechanical test data of non-sterilized cages was provided.
The LnK Lumbar Interbody Fusion Cage System was tested according to the relevant standards, specifically, Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing per ASTM F2077, Static Subsidence testing under Axial Compression, per ASTM F2267, and Expulsion Testing and .
Conclusion 8.
The additional components of LnK Lumbar Interbody Fusion Cage System are as safe, as effective and perform as well as the predicate device. Therefore, the additional components of LnK Lumbar Interbody Fusion Cage System are substantially equivalent to the predicate device (K151140).