(23 days)
No
The summary describes a physical implant (interbody fusion cage) made of PEEK and Tantalum, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies focus on mechanical testing of the physical device.
Yes
The device is indicated for degenerative disc disease of the cervical spine with accompanying radicular symptoms to facilitate intervertebral body fusion. This clearly indicates a therapeutic purpose.
No
The device is an interbody fusion cage system used for treatment of degenerative disc disease, not for diagnosis.
No
The device description explicitly states the device is made of PEEK-OPTIMA® LTI with marker pins made of Unalloyed Tantalum, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The LnK Cervical Interbody Fusion Cage System is a physical implant made of PEEK and Tantalum, designed to be surgically placed in the cervical spine.
- Intended Use: Its purpose is to facilitate bone fusion in the spine, not to analyze biological samples.
The provided information clearly describes a surgical implant, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
LnK Cervical Interbody Fusion Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. LnK Cervical Interbody Fusion Cage System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. LnK. Cervical Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
Product codes
ODP
Device Description
LnK Cervical Interbody Fusion Cage System intended for use as an interbody fusion cage device and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA® LTI with marker pins made of Unalloyed Tantalum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at the C3 to C7 disc levels
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
Mechanical performance of additional components of LnK Cervical Interbody Fusion Cage System is same with predicated LnK Cervical Interbody Fusion Cage System(K143360). They are same product in all aspect, except angle of cage. Predicate components have only 0° angle. The additional components have 7° angle. The additional components are not worse case as demonstrated through finite element (FE) analysis. Therefore, we substitute mechanical test data of additional components of LnK Cervical Interbody Fusion Cage System with it of LnK Cervical Interbody Fusion Cage System (K143360).
The LnK Cervical 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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, connected by flowing lines.
July 15, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
L&K Biomed Company, Limited Ms. Yerim An Regulatory Affairs Specialist #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si Gyeonggi-do, 446-916 Republic of Korea
Re: K151677
Trade/Device Name: LnK Cervical Interbody Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: June 19, 2015 Received: June 22, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K151677
Device Name
LnK Cervical Interbody Fusion Cage System
Indications for Use (Describe)
LnK Cervical Interbody Fusion Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. LnK Cervical Interbody Fusion Cage System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. LnK. Cervical Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92:
| 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: | July 10, 2015 | | | |
Device Identification 2.
| Trade Name | LnK Cervical Interbody Fusion Cage System |
|---|---|
| Common Name | Intervertebral Body Fusion Device |
| Product Code | ODP |
| Classification | Class II |
| Classification Name | intervertebral fusion device with bone graft, cervica |
| 21 CFR 888.3080 |
Primary Predicate or legally marketed devices which are substantially equivalent 3.
• Primary Predicate:
L&K BIOMED Co., Ltd_LnK Cervical Interbody Fusion Cage System (K143360)
Description of the Device 4.
LnK Cervical Interbody Fusion Cage System intended for use as an interbody fusion cage device and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA® LTI with marker pins made of Unalloyed Tantalum.
ട്. Intended use
LnK Cervical Interbody Fusion Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. LnK
4
Cervical Interbody Fusion Cage System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. LnK Cervical Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks 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 |
| No | Item | LnK Cervical Interbody
Fusion Cage System | LnK Cervical Interbody
Fusion 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 | - | K143360 |
| 4 | Product Code | ODP | ODP |
| 5 | Class | ClassII | ClassIl |
| 6 | Intended Use | LnK Cervical Interbody
Fusion Cage System is
indicated for use in skeletally
mature patients with
degenerative disc disease
(DDD) of the cervical spine
with accompanying radicular
symptoms at one disc level.
DDD is defined as discogenic
pain with degeneration of the
disc confirmed by patient
history and radiographic
studies. LnK Cervical
Interbody Fusion Cage
System is used to facilitate
intervertebral body fusion in
the cervical spine at the C3 to
C7 disc levels using autograft
bone. LnK Cervical Interbody
Fusion Cage System is to be
used with supplemental
fixation. Patients should have
at least six (6) weeks of non-
operative treatment prior to
treatment with an
intervertebral cage | LnK Cervical Interbody
Fusion Cage System is
indicated for use in skeletally
mature patients with
degenerative disc disease
(DDD) of the cervical spine
with accompanying radicular
symptoms at one disc level.
DDD is defined as discogenic
pain with degeneration of the
disc confirmed by patient
history and radiographic
studies. LnK Cervical
Interbody Fusion Cage
System is used to facilitate
intervertebral body fusion in
the cervical spine at the C3 to
C7 disc levels using autograft
bone. LnK Cervical Interbody
Fusion Cage System is to be
used with supplemental
fixation. Patients should have
at least six (6) weeks of non-
operative treatment prior to
treatment with an
intervertebral cage |
5
Performance Data 7.
Mechanical performance of additional components of LnK Cervical Interbody Fusion Cage System is same with predicated LnK Cervical Interbody Fusion Cage System(K143360). They are same product in all aspect, except angle of cage. Predicate components have only 0° angle. The additional components have 7° angle. The additional components are not worse case as demonstrated through finite element (FE) analysis. Therefore, we substitute mechanical test data of additional components of LnK Cervical Interbody Fusion Cage System with it of LnK Cervical Interbody Fusion Cage System (K143360).
The LnK Cervical 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 Cervical Interbody Fusion Cage System are substantially equivalent to the device referenced above.