(56 days)
ABTross ALIF Expandable Lumbar Cage System(K221719)
Not Found
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for intervertebral body fusion of the spine, specifically for the treatment of degenerative disc disease (DDD), which aims to alleviate pain and restore function, thereby providing therapy.
No
The PathLoc-TA Expandable Lumbar Cage System is an interbody fusion device designed for use in spinal fusion surgery, not for diagnosing medical conditions. Its purpose is therapeutic, to facilitate fusion of the spine.
No
The device description clearly states the device is a physical implant made of Titanium 6AL-4V Alloy, which is a hardware component.
Based on the provided information, 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, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The PathLoc-TA Expandable Lumbar Cage System is a physical implant designed for surgical insertion into the lumbar spine to facilitate bone fusion. It is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Testing: The description focuses on the mechanical properties and surgical application of the device, not on analyzing biological samples for diagnostic purposes.
Therefore, the PathLoc-TA Expandable Lumbar Cage System falls under the category of a surgical implant or medical device used for treatment, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
PathLoc-TA Expandable Lumbar Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. PathLoc-TA Expandable Lumbar Cage System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).
Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The PathLoc-TA Expandable Lumbar Cage System is interbody fusion devices. This cage system is made of Titanium 6AL-4V Alloy (ASTM F136). And cages are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies.
The cage can be expanded in height using the system instrument after being inserted in the unexpanded state. The cages have serrations on the superior endplate and inferior endplate surfaces area to contact vertebrae bone endplate. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g., posterior pedicle screw and rod systems, anterior or lateral plate systems, and anterior screw and rod systems). All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to S1
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)
Performance testing was performed to demonstrate that the subject PathLoc-TA Expandable Lumbar Cage System is substantially equivalent to other predicate devices.
Static compression, dynamic compression, static and dynamic shear testing according to ASTM F2077, was presented to demonstrate the substantial equivalency of the PathLoc-TA Expandable Lumbar Cage System to the predicate devices.
- Static Axial Compression Test ASTM F 2077 -18 .
- . Static Compression-Shear Test - ASTM F 2077 -18
- . Static Expulsion Test - ASTM draft F-04.25.02.02
- . Static Subsidence Test – ASTM F 2267 – 04 (Reapproved 2018)
- . Dynamic Axial Compression Test- ASTM F 2077 -18
- . Dynamic Compression-Shear Test - ASTM F 2077 -18
Bench testing to evaluate the mechanical properties of the PathLoc-TA Expandable Lumbar Cage System showed a higher or similar mechanical value than predicate marketed devices.
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.
ABTross ALIF Expandable Lumbar Cage System(K221719)
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.
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January 13, 2023
L&K Biomed Co., Ltd. Katherine Kim RA 101, 201, 202 16-25, Dongbaekjungang-ro16 beon-gil Giheung-gu Yongin-si, Gyeonggi-do 17015 Korea
Re: K223474
Trade/Device Name: PathLoc-TA Expandable Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 15, 2022 Received: November 18, 2022
Dear Katherine Kim:
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.
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Katherine D. Kavlock -S
for
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K223474
Device Name
PathLoc-TA Expandable Lumbar Cage System
Indications for Use (Describe)
PathLoc-TA Expandable Lumbar Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. PathLoc-TA Expandable Lumbar Cage System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).
Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
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
| Submitter's Name: | L&K BIOMED Co., Ltd. |
|---|---|
| Submitter's Address: | #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil |
| Giheung-gu, Yongin-si, Gyeonggi-do, 17015, Korea | |
| Submitter's Telephone: | +82-2-6717-1983 |
| Contact Person: | Katherine Kim |
| khkim@lnkbiomed.com / ra@lnkbiomed.com |
2. DEVICE NAME
| Trade or Proprietary Name | PathLoc-TA Expandable Lumbar Cage System |
|---|---|
| Common or Usual Name | Intervertebral Body Fusion Device, Intervertebral cage, Spacer |
| Regulation class / Number | ClassII, CFR 888.3080 |
| Regulation Name | Intervertebral Body Fusion Device |
| Product Code | MAX |
| Classification Panel | Spinal Devices (DHT6B) |
3. PREDICATE DEVICE
The subject PathLoc-TA Expandable Lumbar Cage System is substantially equivalent to the following devices:
Primary Predicate Device: ABTross ALIF Expandable Lumbar Cage System(K221719)
4. DESCRIPTION OF THE DEVICE
The PathLoc-TA Expandable Lumbar Cage System is interbody fusion devices. This cage system is made of Titanium 6AL-4V Alloy (ASTM F136). And cages are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies.
The cage can be expanded in height using the system instrument after being inserted in the unexpanded state. The cages have serrations on the superior endplate and inferior endplate surfaces area to contact vertebrae bone endplate. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g., posterior pedicle screw and rod systems, anterior or lateral plate systems, and anterior screw and rod systems). All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances.
INDICATION FOR USE న్.
PathLoc-TA Expandable Lumbar Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. PathLoc-TA Expandable Lumbar Cage System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease
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Image /page/4/Picture/0 description: The image shows the text "K223474 Page 2 of 3" at the top. Below that is the logo for L&K BIOMED. The logo consists of the text "LEARNING & KNOWLEDGE BASED L&K BIOMED" in a sans-serif font, with the "L&K BIOMED" text being larger and bolder. To the right of the text is a circular graphic made up of smaller blue circles.
(DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation.
6. PERFORMANCE DATA
Performance testing was performed to demonstrate that the subject PathLoc-TA Expandable Lumbar Cage System is substantially equivalent to other predicate devices.
Static compression, dynamic compression, static and dynamic shear testing according to ASTM F2077, was presented to demonstrate the substantial equivalency of the PathLoc-TA Expandable Lumbar Cage System to the predicate devices.
- Static Axial Compression Test ASTM F 2077 -18 .
- . Static Compression-Shear Test - ASTM F 2077 -18
- . Static Expulsion Test - ASTM draft F-04.25.02.02
- . Static Subsidence Test – ASTM F 2267 – 04 (Reapproved 2018)
- . Dynamic Axial Compression Test- ASTM F 2077 -18
- . Dynamic Compression-Shear Test - ASTM F 2077 -18
Bench testing to evaluate the mechanical properties of the PathLoc-TA Expandable Lumbar Cage System showed a higher or similar mechanical value than predicate marketed devices.
7. MATERIAL
The PathLoc-TA Expandable Lumbar Cage System is manufactured from Ti-6A1-4V ELI titanium alloy (ASTM F136). This this is the same material used in the predicate devices.
COMPARISON OF TECHNICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 8.
The subject and predicate devices have identical technological characteristics and there is not any new issues of safety and effectiveness. the following characteristics are same between the subject and predicates:
- י Instruction for use
- י Design and sizes
- -Expanding Mechanism
- . Material
- י Approach
- . Sterilization & Method
- . Manufacturing process
SUBSTANTIAL EQUIVALENCE AND CONCLUSION 9.
The subject PathLoc-TA Expandable Lumbar Cage System have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial
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Image /page/5/Picture/0 description: The image shows the text 'K223474' and 'Page 3 of 3' at the top. Below that is the logo for L&K BIOMED. The logo has the text 'LEARNING & KNOWLEDGE JOINED' above 'L&K BIOMED'. To the right of the text is a circular graphic made of smaller blue circles.
equivalence of the subject device to the predicate devices.
The overall data lead to the conclusion that the PathLoc-TA Expandable Lumbar Cage System is substantially equivalent to the predicate devices.