(221 days)
Not Found
No
The summary describes a physical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used for spinal fusion procedures to treat symptomatic degenerative disc disease, which involves addressing a medical condition and restoring function.
No
Explanation: The Stable-L™ Standalone Lumbar Interbody System is an implantable device used for spinal fusion procedures. Its purpose is therapeutic (fusion) rather than diagnostic (identifying a condition).
No
The device description clearly states the device is made of Ti-6A1-4V and is an implant offered in various physical dimensions, indicating it is a hardware device.
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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Stable-L Standalone Lumbar Interbody System is a physical implant designed for surgical insertion into the lumbar spine to facilitate spinal fusion. It is a structural device, not a device that analyzes biological samples.
- Lack of Diagnostic Function: The description focuses on the mechanical properties, materials, and surgical application of the implant. There is no mention of it being used to diagnose, monitor, or screen for any condition by analyzing biological samples.
Therefore, the Stable-L Standalone Lumbar Interbody System falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Stable-L Standalone Lumbar Interbody System is indicated for spinal fusion procedures in skeletally mature patients. Stable-L is designed for use with autogenous and/or allogenic bone graft comprised of cancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. Stable-L is intended for use in interbody fusions in the lumbar spine from L2 to S1 at one or two adjacent levels in the treatment of symptomatic degenerative disc disease (DDD). The DDD patients may also have up to Grade 1 spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Each interbody fusion device having a lordotic angle 20° or less is intended to be used with the bone screws provided and requires no additional fixation. However, for hyperlordotic devices (> 20° lordosis), due to the increased risk of anterior migration with hyperlordotic implants, the devices should be used with the bone screws provided and supplemental fixation such as posterior fixation.
Product codes
OVD
Device Description
The Stable-L™ Standalone Interbody System is made of Ti-6A1-4V. The implant is offered in various angles, widths, heights, and lengths, and with various lengths of screws, to meet patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.
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
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 performance testing data was provided as part of this submission to establish substantial equivalence for its use. Static and dynamic compression and compression shear testing per ASTM F2077, screw pushout testing, and implant expulsion testing were performed to establish substantial equivalence. Documentation provided demonstrates that the Stable-L Standalone Lumbar Interbody System is substantially equivalent to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K203201, K203278, K181702, K162358, K101301, K073109, K101310
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 18, 2022
Nexus Spine, LLC Jared Crocker Vice President of Quality and Regulatory Affairs 2825 East Cottonwood Parkway, Suite 330 Salt Lake City, Utah 84121
Re: K212498
Trade/Device Name: Stable-L Standalone Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: February 17, 2022 Received: February 18, 2022
Dear Jared Crocker:
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,
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
2
Indications for Use
510(k) Number (if known) K212498
Device Name
Stable-L Standalone Lumbar Interbody System
Indications for Use (Describe)
The Stable-L Standalone Lumbar Interbody System is indicated for spinal fusion procedures in skeletally mature patients. Stable-L is designed for use with autogenous and/or allogenic bone graft comprised of cancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. Stable-L is intended for use in interbody fusions in the lumbar spine from L2 to S1 at one or two adjacent levels in the treatment of symptomatic degenerative disc disease (DDD). The DDD patients may also have up to Grade 1 spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Each interbody fusion device having a lordotic angle 20° or less is intended to be used with the bone screws provided and requires no additional fixation. However, for hyperlordotic devices (> 20° lordosis), due to the increased risk of anterior migration with hyperlordotic implants, the devices should be used with the bone screws provided and supplemental fixation such as posterior fixation.
| 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
| Submitter: | Nexus Spine LLC |
|---|---|
| Contact Person: | Mr. Jared Crocker, Vice President of Quality and Regulatory Affairs |
| 2825 East Cottonwood Parkway Suite 330 | |
| Salt Lake City, UT 84121 | |
| Telephone: (801) 702-8592 | |
| Fax: (801) 702-8585 | |
| Date Prepared: | March 17, 2022 |
| Trade Name: | Stable-L Standalone Lumbar Interbody System |
| Classification, Name | |
| and Number: | Class II |
| Intervertebral body fusion device | |
| 21 CFR 888.3080 | |
| Product Code: | OVD |
Predicate Device(s):
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| Primary Predicate | ||
| NuVasive, Incorporated | Brigade Standalone System | K203201 |
| Additional Predicates | ||
| Globus Medical | Independence MIS Anterior Lumbar | |
| Interbody Fusion System | K203278 | |
| Nexus Spine, LLC | Tranquil-L Interbody System | K181702 |
| Synthes USA Products, LLC | SYNFIX Evolution System | K162358 |
| Centinel Spine | STALIF Midline | K101301 |
| Centinel Spine | STALIF TT | K073109 |
| Theken Spine | Vu aPOD | K101310 |
Device Description: The Stable-L™ Standalone Interbody System is made of Ti-6A1-4V. The implant is offered in various angles, widths, heights, and lengths, and with various lengths of screws, to meet patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.
4
The purpose of this traditional 510(k) is to gain clearance for this device. Intended Use: The Stable-L Standalone Lumbar Interbody System is indicated for spinal fusion procedures in skeletally mature patients. Stable-L is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. Stable-L is intended for use in interbody fusions in the lumbar spine from L2 to S1 at one or two adjacent levels in the treatment of symptomatic degenerative disc disease (DDD). The DDD patients may also have up to Grade 1 spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Each interbody fusion device having a lordotic angle 20° or less is intended to be used with the bone screws provided and requires no additional fixation. However, for hyperlordotic devices (> 20° lordosis), due to the increased risk of anterior migration with hyperlordotic implants, the devices should be used with the bone screws provided and supplemental fixation such as posterior fixation. Statement of Technological Comparison: The subject spacer system is similar to predicate devices in regard to indications for use, manufacturing process, materials, means of primary and secondary fixation, operating principles, and non-clinical performance standards. Performance Data: Mechanical performance testing data was provided as part of this submission to establish substantial equivalence for its use. Static and dynamic compression and compression shear testing per ASTM F2077, screw pushout testing, and implant expulsion testing were performed to Conclusion: establish substantial equivalence. Documentation provided demonstrates that the Stable-L Standalone Lumbar Interbody System is substantially equivalent to predicate devices.