(34 days)
Not Found
No
The summary describes a mechanical interbody fusion device made of titanium with various sizes and expansion capabilities. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device, the BluEX Lumbar Expandable Cage System, is implanted in the spine for intervertebral body fusion to treat degenerative disc disease, which is a therapeutic intervention.
No
The device, BluEX Lumbar Expandable Cage System, is described as an interbody fusion device intended for use in spinal fusion surgery, not for diagnosing conditions. Its purpose is to facilitate fusion with bone graft.
No
The device description clearly states it is an interbody fusion device made of Titanium 6AL-4V Alloy, which is a physical hardware component. The summary also details mechanical performance testing of this hardware.
Based on the provided text, 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 detect diseases, conditions, or infections.
- Device Description: The BluEX Lumbar Expandable Cage System is an implantable surgical device made of Titanium. It is designed to be surgically inserted into the lumbar spine to facilitate bone fusion.
- Intended Use: The intended use is for intervertebral body fusion in the spine, a surgical procedure, not for testing biological samples.
The description clearly indicates a surgical implant used directly within the body, not a device used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
BluEX Lumbar Expandable 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.
BluEX Lumbar Expandable Cage System is intended for use at either one or two contiguous levels in the lumbar spine, from L1 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 radiographic studies.
Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device. The BluEX Lumbar Expandable Cage System must be used with supplementary internal spinal fixation system that are cleared by the FDA for use in the lumbar spine. 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 BluEX Lumbar Expandable Cage System is an interbody fusion device. This cage system is made of Titanium 6AL-4V Alloy (ASTM F136). And the cages are offered in a variety of widths, lengts and lordotic angles designed to adapt to a variety of patient anatomies.
This product consists of BluEX-T, BluEX-ATP, BluEX-LT and BluEX-A which are classified by surgical approach (refer to below table 1. BluEX Lumbar Expandable Cage System)
The cage can be expanded in height using the system inserted in the unexpanded state. The cages have serrations on the superior and inferior surfaces designed for fixation.
The BluEX Lumbar Expandable Cage System allows packing autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstance.
Surgical approach
- BluEX-T is to be implanted via transforaminal and posterior approach.
- BluEX-TC is to be implanted via transforaminal and posterior approach.
- BluEX-ATP is to be implanted via anterior to psoas approach and lateral approach.
- BluEX-L is to be implanted via direct lateral approach.
- BluEX-LT is to be implanted via direct lateral approach.
- BluEX-A is to be implanted via anterior approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine, from L1 to 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 test (performance test)
The results of these mechanical tests were found to be equivalent to or higher than the acceptable criteria compared to the predicate devices PathLoc Lumbar Interbody Fusion (K213441) for Static and Dynamic Compression and shear test and ANYPLUS ALIF PEEK CAGES, PLF PEEK CAGES, T-PLF PEEK CAGES (K131612) for subsidence value as stated in the Acceptable criteria. In addition, the dynamic tests were conducted and height changes observed at regular intervals were confirmed to be unchanged. Therefore, this test report concludes that the BluEX Lumbar Expandable Cage system has mechanical safety.
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.
K213441, K223474, K231680, K131612
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. Ms. Kihyang Kim Vice Chairman #101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu Yongin-si. Gyeonggi-do 17015 South Korea
Re: K242829
Trade/Device Name: BluEX Lumbar Expandable Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: September 18, 2024 Received: September 19, 2024
Dear Ms. 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
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 Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242829
Device Name
BluEX Lumbar Expandable Cage System
Indications for Use (Describe)
BluEX Lumbar Expandable 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.
BluEX Lumbar Expandable Cage System is intended for use at either one or two contiguous levels in the lumbar spine, from L1 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 radiographic studies.
Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device. The BluEX Lumbar Expandable Cage System must be used with supplementary internal spinal fixation system that are cleared by the FDA for use in the lumbar spine. Hyperlordotic interbody devices (≥20 lordosis) must be used with at least anterior supplemental fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K242829 Page 1 of 2
510(k) #:
510(k) Summary
Prepared on: 2024-10-22
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | L&K BIOMED Co., Ltd. |
|---|---|
| Applicant Address | #101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, |
| Yongin-si Gyeonggi-do 17015 Korea, South | |
| Applicant Contact Telephone | 82-10-5477-0325 |
| Applicant Contact | Ms. Kihyang Kim |
| Applicant Contact Email | khkim@lnkbiomed.com |
| Device Name | 21 CFR 807.92(a)(2) |
| Device Trade Name | BluEX Lumbar Expandable Cage System |
| Common Name | 3080 -Intervertebral body fusion device |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Regulation Number | 21 CFR 8 |
| Product Code(s) | MAX |
| Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) Product Code |
| K213441 | PathLoc Interbody Fusion Cage System MAX |
| K223474 | PathLoc-TA Expandable Lumbar Cage System MAX |
| K231680 | AccelFix Lumbar Expandable cage System MAX |
| K131612 | AnyPlus Peek Cage MAX |
| Device Description Summary 21 CFR 807.92(a)(4) |
Device Description Summary
The BluEX Lumbar Expandable Cage System is an interbody fusion device. This cage system is made of Titanium 6AL-4V Alloy (ASTM F136). And the cages are offered in a variety of widths, lengts and lordotic angles designed to adapt to a variety of patient anatomies.
This product consists of BluEX-T, BluEX-ATP, BluEX-LT and BluEX-A which are classified by surgical approach (refer to below table 1. BluEX Lumbar Expandable Cage System)
The cage can be expanded in height using the system inserted in the unexpanded state. The cages have serrations on the superior and inferior surfaces designed for fixation.
The BluEX Lumbar Expandable Cage System allows packing autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstance.
Surgical approach
- · BluEX-T is to be implanted via transforaminal and posterior approach.
- · BluEX-TC is to be implanted via transforaminal and posterior approach.
- · BluEX-ATP is to be implanted via anterior to psoas approach and lateral approach.
- BluEX-L is to be implanted via direct lateral approach.
5
- · BluEX-LT is to be implanted via direct lateral approach.
· BluEX-A is to be implanted via anterior approach.
Intended Use/Indications for Use
BluEX Lumbar Expandable 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.
BluEX Lumbar Expandable Cage System is intended for use at either one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DD) 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 radiosraphic studies.
Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device. The BluEX Lumbar Expandable Cage System must be used with supplementary internal spinal fixation system that are cleared by the FDA for use in the lumbar spine. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
Indications for Use Comparison
The subject BluEX Lumbar Expandable Cage System have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, material and intended use. The information provided within this premarket notification supports substantial equivalence of the predicate devices. The overall data lead to the conclusion that the BluEX Lumbar Expandable Cage System is substantially equivalent to the predicate devices.
Technological Comparison
The BluEX Lumbar Expandable Cage System is undergone a comprehensive battery of non-clinical testing, including chemical, physical. Testing has provided reasonable assurance of safety and effectiveness for its intended use and supports a determination of substantial equivalence. The design feature, indications for use the subject devices are substantially equivalent to the predicate devices.
Primary Predicate Device: PathLoc Lumbar Interbody Fusion Cage System(K213441) Additional Predicate Device: PathLoc-TA Expandable Lumbar Cage System(K223474) AccelFix Lumbar Expandable Cage System(K231860) AnyPlus Peek Cage(K131612)
The subject and predicate devices are substantially equivalent in the areas of materials, design, indications for use, intended use and operational principles.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Recognition No. 11-347 ASTM F2077-18 Test Methods for Intervertebral Body Fusion Devices Recognition No. 11-185 ASTM F2267-04 (Reapproved 2018) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
N/A
Mechanical test (performance test)
The results of these mechanical tests were found to be equivalent to or higher than the acceptable criteria compared to the predicate devices PathLoc Lumbar Interbody Fusion (K213441) for Static and Dynamic Compression and shear test and ANYPLUS ALIF PEEK CAGES, PLF PEEK CAGES, T-PLF PEEK CAGES (K131612) for subsidence value as stated in the Acceptable criteria. In addition, the dynamic tests were conducted and height changes observed at regular intervals were confirmed to be unchanged. Therefore, this test report concludes that the BluEX Lumbar Expandable Cage system has mechanical safety.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)