(142 days)
List of Reference Device(s) K/DEN numbers:
Not Found
No
The summary describes a physical implantable device and its mechanical properties, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "intervertebral body fusion device" intended for spinal fusion procedures at specific levels of the spine in patients with degenerative disc disease, indicating a direct therapeutic purpose.
No
The device is an intervertebral body fusion device intended for spinal fusion procedures, acting as an implant to treat degenerative disc disease. It does not perform any diagnostic functions like analyzing patient data or images to identify a medical condition.
No
The device description clearly states it is a physical implantable device made of titanium alloy, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is an "intervertebral body fusion device" intended for surgical implantation in the spine to facilitate bone fusion. It is a physical implant used within the body, not a device used to test samples outside the body.
The information provided describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
Lucent® 3D intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
These devices are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).
This device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
Product codes
MAX
Device Description
The subject devices are intervertebral body fusion devices for use in lumbar spinal surgery. They may also be referred to as interbody fusion devices or interbody cages. The devices are generally box-shaped with various holes throughout their design to allow for the placement of autograft or allogenic bone graft. They include a lid which further facilitates installation of bone graft and which is shut prior to implantation. The exterior of the devices has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the devices from migrating once they are implanted.
The devices submitted herein are additively manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, 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)
Performance testing included:
- Static Compression Testing per ASTM F 2077-18
- Static Compression Shear Testing per ASTM F 2077-18
- Dynamic Compression Testing per ASTM F 2077-18
- Dynamic Compression Shear Testing per ASTM F 2077-18
- Subsidence Testing per ASTM F 2267-18
All data indicates that the device will perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
March 26, 2021
Spinal Elements, Inc. Julie Lamothe, Ph.D., MBA Vice President of Regulatory Affairs 3115 Melrose Dr., Suite 200 Carlsbad, California 92010
Re: K203254
Trade/Device Name: Lucent® 3D Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: February 23, 2021 Received: February 25, 2021
Dear Dr. Lamothe:
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
1
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,
Brent L. 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
2
Indications for Use
510(k) Number (if known)
Device Name Lucent® 3D
Indications for Use (Describe)
Lucent® 3D intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
These devices are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).
This device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary Lucent® 3D
510(k) Number: K203254
| Manufacturer Identification
Submitted by: | Spinal Elements, Inc.
3115 Melrose Dr., Suite 200
Carlsbad, CA 92010
P. 760-607-0121
F. 760-607-0125 |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Julie Lamothe
Spinal Elements, Inc.
3115 Melrose Dr., Suite 200
Carlsbad, CA 92010
760-607-1816
jlamothe@spinalelements.com |
| Date Prepared: | October 22, 2020 |
| Proprietary Name | Lucent® 3D |
| Regulation Name | Intervertebral Body Fusion Device |
| Device Classification | 21 CFR 888.3080 (Appliance, Fixation Spinal
Intervertebral Body) |
| Proposed Regulatory Class | Class II |
| Device Product Code | MAX |
Device Description
The subject devices are intervertebral body fusion devices for use in lumbar spinal surgery. They may also be referred to as interbody fusion devices or interbody cages. The devices are generally box-shaped with various holes throughout their design to allow for the placement of autograft or allogenic bone graft. They include a lid which further facilitates installation of bone graft and which is shut prior to implantation. The exterior of the devices has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the devices from migrating once they are implanted.
The devices submitted herein are additively manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001.
Indication for Use
Lucent® 3D intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2- S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration
4
of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
These devices are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
This device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
Substantial Equivalence
The subject devices are substantially equivalent in indications for use, surgical technique, design features, manufacturing methods and raw materials to the following predicate devices:
Lucent® devices (K150061): Primary Predicate
OmegaLIF devices (K150395): Additional Predicate
Technological Characteristics
The subject device was established as substantially equivalent to another predicate device cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate device through comparison in areas including design, intended use, operating principle and function.
Performance Data
Performance testing included:
- Static Compression Testing per ASTM F 2077-18
- Static Compression Shear Testing per ASTM F 2077-18
- . Dynamic Compression Testing per ASTM F 2077-18
- Dynamic Compression Shear Testing per ASTM F 2077-18 ●
- . Subsidence Testing per ASTM F 2267-18
All data indicates that the device will perform as intended.
CONCLUSIONS
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject device has been shown to be substantially equivalent to the aforementioned predicate devices cleared by FDA for commercial distribution in the United States.