(86 days)
Not Found
No
The summary describes a physical implant device and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as a vertebral body replacement and an intervertebral body fusion device, intended to treat conditions like tumor, trauma, and degenerative disc disease by repairing or replacing damaged spinal structures. This aligns with the definition of a therapeutic device that treats or prevents disease or injury.
No
The device is a medical implant (vertebral body replacement, intervertebral body fusion device) used in surgical procedures to treat conditions like tumor, trauma, or degenerative disc disease. It does not diagnose any condition.
No
The device description clearly states the device is composed of a main device body and fixation screws made from titanium alloy or PEEK, indicating it is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states this device is a surgical implant (vertebral body replacement and intervertebral body fusion device) intended to be surgically placed within the body to replace or fuse spinal structures. It is a physical device used in a surgical procedure, not a test performed on a specimen outside the body.
The text focuses on the device's material, shape, surgical placement, and intended anatomical location within the spine. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
N/A
Intended Use / Indications for Use
When used as a vertebral body replacement, the device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
When used as an intervertebral body fusion device is 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). This device is 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 autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
Product codes (comma separated list FDA assigned to the subject device)
MQP; MAX, OVD
Device Description
Spinal Elements' Lucent Magnum+ device is composed of a main device body and fixation screws. The main device body is generally oval-shaped with various holes throughout its geometry. The superior and inferior surfaces of the device have engagement members to prevent migration once surgically positioned. The main implant body has holes through it that allow for the passage of bone screws that affix to bone to help prevent migration.
Devices are available in a multitude of sizes. Device bodies are made from either titanium alloy (Ti-6Al-4V), conforming to ASTM F 136 or ISO 5832-3, or polyetheretherketone (PEEK-Optimal), conforming to ASTM F 2026. Screws are made from titanium alloy (Ti-6Al-4V), conforming to ASTM F 136 or ISO 5832-3. All implants are intended for single use only and should not be reused under any circumstances. Components from this system should not be used in conjunction with components from other systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and/or thoracolumbar spine (T1-L5), lumbosacral spine (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)
Not Found
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
510(k) Summary Lucent® Magnum+
510(k) Number
| Manufacturer Identification
Submitted by: | Spinal Elements, Inc.
2744 Loker Ave. W., Suite 100
Carlsbad, CA 92010
760-607-0121 | SEP 1 1 2008 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Information: | Kerri DiMartino
Regulatory Affairs Specialist
Spinal Elements, Inc.
2744 Loker Ave. W., Suite 100
Carlsbad, CA 92010
760-607-1816
kdimartino@spinalelements.com | |
| Date Prepared: | September 3, 2008 | |
| Device Identification | | |
| Proprietary Name | Lucent® Magnum+ | |
| Common Name | Vertebral Body Replacement;
Intervertebral Body Fusion Device | |
| Device Classification | 21 CFR 888.3060 (spinal intervertebral body
fixation orthosis);
21CFR 888.3080 (orthosis, spinal intervertebral
fusion) | |
| Proposed Regulatory Class | Class II | |
| Device Product Code | MQP; MAX | |
Device Description
Spinal Elements' Lucent Magnum+ device is composed of a main device body and fixation screws. The main device body is generally oval-shaped with various holes throughout its geometry. The superior and inferior surfaces of the device have engagement members to prevent migration once surgically positioned. The main implant body has holes through it that allow for the passage of bone screws that affix to bone to help prevent migration.
Devices are available in a multitude of sizes. Device bodies are made from either titanium alloy (Ti-6Al-4V), conforming to ASTM F 136 or ISO 5832-3, or polyetheretherketone (PEEK-Optimal), conforming to ASTM F 2026. Screws are made from titanium alloy (Ti-6Al-4V), conforming to ASTM F 136 or ISO 5832-3. All implants are intended for single use only and should not be reused under any
1
K081711 (pg 2 of 2)
Spinal Elements, Inc.
Premarket Notification - Lucent® Magnum+
circumstances. Components from this system should not be used in conjunction with components from other systems.
Intended Use of the Device
When used as a vertebral body replacement:
When used as a vertebral body replacement, the device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
When used as an intervertebral body fusion device:
When used as an intervertebral body fusion device is 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 at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
This device is 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 autogenous bone graft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
Substantial Equivalence
The Lucent Magnum+ device was shown to be substantially equivalent in indications for use, general design features, function, and materials to the following predicates: Lucent® by Spinal Elements (K071724), Lucent® Magnum by Spinal Elements (K073348), and STALIF TTM by Surgicraft (K073109).
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is an abstract symbol resembling a stylized human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spinal Elements, Incorporated % Ms. Kerri DiMartino Regulatory Affairs Specialist 2744 Loker Avenue West. Suite 100 Carlsbad, California 92010
SEP 1 2 2011
Re: K081711 Trade/Device Name: Lucent® Magnum+ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD. MOP Dated: June 13, 2008 Received: June 17, 2008
Dear Ms. DiMartino:
This letter corrects our substantially equivalent letter of September 11, 2008.
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 (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.
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
3
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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
Director
Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): ¡ՀՀՑ ) 7 ||
Lucent® Magnum+ Device Name:
Indications for Use:
When used as a vertebral body replacement:
When used as a vertebral body replacement, the device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
When used as an intervertebral body fusion device:
When used as an intervertebral body fusion device is 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).
This device is 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 autogenous bone graft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use
(21 CFR 807 Subpart C) |
| ------------------------------------------------- | --- | -------- | ------------------------------------------------ |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Page 1 of 1
Division of General, Restorative, and Neurological Devices
16081711
510(k) Number_