(115 days)
Not Found
No
The summary describes intervertebral body fusion devices and their coating. There is no mention of AI, ML, image processing, or any software functionality that would suggest the use of these technologies. The performance studies focus on the coating's surface topography.
Yes
The device, an intervertebral body fusion device, is intended for spinal fusion procedures to treat degenerative disc disease and related conditions, which directly addresses a medical problem.
No
Explanation: The device is described as an intervertebral body fusion device and is intended for spinal fusion procedures, indicating a therapeutic rather than diagnostic purpose. Its use follows a diagnosis (DDD confirmed by history and radiographic studies), but the device itself does not perform diagnostics.
No
The device description explicitly states it is a "plasma sprayed coating of commercially pure titanium" applied to "Spinal Elements' devices," indicating a physical component. The intended use also describes "intervertebral body fusion devices," which are physical implants.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are 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 that these are intervertebral body fusion devices intended for surgical implantation in the spine to facilitate spinal fusion. They are physical implants used within the body, not for testing samples outside the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, diagnostic testing, or any of the typical characteristics of an IVD.
Therefore, this device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Lucent
Lucent 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).
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, 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 non-operative treatment prior to being treated with this device.
Lucent Magnum+ is an intervertebral body fusion device intended for spinal fusion procedure 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 autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
Crystal
Crystal devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach from the C2-C3 disc space to the C7-T1 disc space and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.
Vertu
Vertu devices are stand-alone interbody fusion devices intended for spinal fusion procedures at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed 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) weeks non-operative treatment prior to being treated with these devices.
The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.
Product codes (comma separated list FDA assigned to the subject device)
MAX, OVD, MQP, ODP, OVE
Device Description
Spinal Elements' Ti-Bond® is an additive plasma sprayed coating of commercially pure titanium conforming to ASTM F1580. Spinal Elements' devices are coated with Ti-Bond®f on their surfaces. Spinal Elements Ti-Bond® coating presents a macro-, a micro and a nano-surface structure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, Lumbosacral (L2-S1), Cervical C2-C3 disc space to C7-T1 disc space
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)
In support of this 510(k) Premarket Notification, Spinal Elements has conducted nonclinical testing demonstrating that the Spinal Elements Ti-Bond® coating present a surface topography at a macro, a micro and a nano scale.
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.
K110632, K150061, K133218, K152011, K122967/K170235
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food & Drug Administration. The Department of Health and Human Services logo is on the left and consists of a stylized caduceus. The U.S. Food & Drug Administration logo is on the right and consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 2, 2018
Spinal Elements Inc. Julie Lamothe Sr. Director Regulatory Affairs 3115 Melrose Dr., Suite 200 Carlsbad, California 92010
Re: K181837
Trade/Device Name: Spinal Elements Ti-Bond coated devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD, MQP, ODP, OVE Dated: August 3, 2018 Received: August 6, 2018
Dear Ms. 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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Melissa Hall -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181837
Device Name
Spinal Elements Ti-Bond coated devices
Indications for Use (Describe)
Lucent
Lucent 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).
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, 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 non-operative treatment prior to being treated with this device.
Lucent
Lucent Magnum+ is an intervertebral body fusion device intended for spinal fusion procedure 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 nonfusion spinal surgery at the involved spinal level(s).
This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
Crystal
Crystal devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach from the C2-C3 disc space to the C7-T1 disc space and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.
Vertu
Vertu devices are stand-alone interbody fusion devices intended for spinal fusion procedures at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed 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) weeks non-operative treatment prior to being treated with these devices.
The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.
3
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510(k) Summary
Spinal Elements Ti-Bond coated devices
510(k) Number: K181837
| Manufacturer Identification
Submitted by: | Spinal Elements, Inc.
3115 Melrose Dr., Suite 200
Carlsbad, CA 92010
760-607-0121 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Julie Lamothe
Senior Director, Regulatory Affairs/Quality Assurance
Spinal Elements, Inc.
3115 Melrose Dr., Suite 200
Carlsbad, CA 92010
760-607-1816
jlamothe@spinalelements.com |
| Date Prepared: | October 30th 2018 |
| Proprietary Name | Spinal Elements Ti-Bond coated devices |
| Device Classification | 21 CFR Section 888.3080 |
|---|---|
| Proposed Regulatory | Class II |
| Class Device Product Code | MAX, OVD, MQP, ODP, OVE |
Device Description
Spinal Elements' Ti-Bond® is an additive plasma sprayed coating of commercially pure titanium conforming to ASTM F1580. Spinal Elements' devices are coated with Ti-Bond®f on their surfaces. Spinal Elements Ti-Bond® coating presents a macro-, a micro and a nano-surface structure.
The indications for use of the devices coated with Ti-Bond® are not being modified from the ones cleared in their respective 510(k) and are as followed:
Indications for Use
Lucent
5
Lucent 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).
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 non-operative treatment prior to being treated with this device.
Lucent
Lucent Magnum+ is an intervertebral body fusion device intended for spinal fusion procedure 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 autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
Crystal
Crystal devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach from the C2-C3 disc space to the C7-T1 disc space and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.
Vertu
Vertu devices are stand-alone interbody fusion devices intended for spinal fusion procedures at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
6
K181837 Page 3 of 3
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.
The implant is designed to accommodate two screws should be used to ensure adequate fixation of the implant.
Substantial Equivalence
The proposed characterization of the Ti-Bond® coating does not modify the devices previously cleared by Spinal Elements. Devices design, device specifications, material, manufacturing process, operating principle and indication for use are identical. Ti-Bond® coating is identical to the coating of the predicate devices coating: Primary Predicate: Spinal Elements Lucent devices - K110632. Additional Predicate: Spinal Elements Lucent devices - K150061 Additional Predicate: Spinal Elements Crystal/Vertu devices - K133218 Additional Predicate: Spinal Elements Lucent XP devices - K152011 Additional Predicate: Spinal Elements Lucent Lateral devices – K122967/K170235
Technological Characteristics
There are no changes to the predicate devices coating. All technical characteristics remain identical.
Performance Data
In support of this 510(k) Premarket Notification, Spinal Elements has conducted nonclinical testing demonstrating that the Spinal Elements Ti-Bond® coating present a surface topography at a macro, a micro and a nano scale.
Conclusion
Based on the indications for use, technological characteristics, and comparison to predicate device, the subject device with the Ti-Bond® coating has been shown to be substantially equivalent to the aforementioned predicate device cleared by FDA for commercial distribution in the United States.