(121 days)
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing related to AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
No
Explanation: A therapeutic device is used to treat a disease or condition. While this device is used in a surgical procedure, its primary function is to facilitate fusion by providing structural support and space for bone graft, rather than actively treating the underlying disease or condition itself. It's a component of a larger therapeutic strategy (fusion surgery) but not a therapeutic device in its own right in this context.
No
This device is an interbody fusion system designed for the treatment of degenerative disc disease by facilitating fusion, not for diagnosing conditions.
No
The device description explicitly states it is comprised of a cage and two fixation anchors made from Ti-6Al-4V, which are physical hardware components. The performance studies also focus on mechanical testing of these physical components.
No, 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: The Stable-C Interbody System is a physical implant (cage and fixation anchors) designed to be surgically placed in the cervical spine to facilitate bone fusion.
- Intended Use: The intended use is for surgical implantation in patients with degenerative disc disease to promote fusion, not to analyze samples from the body.
The provided information clearly describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Stable-C Interbody System is an anterior cervical interbody fusion system. The Stable-C Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is to be used with supplemental fixation cleared for use in the cervical spine. The system is intended to be used with autogenous or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.
Product codes
OVE, ODP
Device Description
The Stable-C Interbody System is an anterior cervical interbody device comprised of a cage (lordotic angles of 0 , 6°, and 12°) made from Ti-6Al-4V per ASTM F3001 and two fixation anchors made from Ti-6-Al-4V ELI per ASTM F136. The device is offered in a variety of sizes to accommodate 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
Cervical spine, C2-T1
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
Mechanical testing was performed to demonstrate that the Stable-C Interbody System is substantially equivalent to the predicate devices listed above. The following tests were performed:
- Static and dynamic compression testing per ASTM F2077
- Static and dynamic compression-shear testing per ASTM F2077
- Static and dynamic torsion testing per ASTM F2077
- Wear debris/mass change analysis during ASTM F2077, per ASTM 1877 and ASTM F1714.
- Expulsion testing.
- Equivalence rationale for subsidence per ASTM F2267.
- Custom static compression testing of the locking mechanism.
Key Metrics
Not Found
Predicate Device(s)
Nexus Spine Tranquil (K170297), Genesys Spine AIS-C (K181295), LDR Spine ROI-C (K113559, K150765, K151934), Choice Spine Acapella (K171489), Osseus Red Ruby (K122008), Centinel Spine STALIF-C (K072415, K120819, K142079, K150053), Stryker Spine Anchor-C (K102606), Spinal Elements Mosaic-C (K133218, K071833), Renovis Tesera SC (K153250), NuVasive CoRoent Small Interlock II (K170961), Zimmer Trabecular Metal Fusion Device (K103033, K111119)
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
October 19, 2018
Image /page/0/Picture/1 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Nexus Spine, LLC Jared Crocker Director of Quality and Regulatory Affairs 2825 East Cottonwood Parkway, Suite 330 Salt Lake City, Utah 84121
Re: K181621
Trade/Device Name: Stable-C Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: September 18, 2018 Received: September 20, 2018
Dear Mr. 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 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
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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,
Brent Showalter -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181621
Device Name Stable-C Interbody System
Indications for Use (Describe)
The Stable-C Interbody System is an anterior cervical interbody fusion system. The Stable-C Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is to be used with supplemental fixation cleared for use in the cervical spine. The system is intended to be used with autogenous or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.
| 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) |
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510(k) Summary Submitted by:
Mr. Jared Crocker, Director 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: 18-Oct-2018
Device Name and Classification
| Trade Name: | Stable-C Interbody System |
|---|---|
| Common Name: | Stable-C Interbody System |
| Classification Name: | Intervertebral Body Fusion Device with Integrated Fixation, |
| Cervical | |
| Intervertebral Body Fusion Device | |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.3080 |
| Product Code: | OVE, ODP |
Predicate Devices
The subject Stable-C Interbody System is substantially equivalent to multiple predicate devices. The Nexus Spine Tranquil (K170297) serves as the primary predicate. Secondary predicates include the Genesys Spine AIS-C (K181295), LDR Spine ROI-C (K113559, K150765, K151934), Choice Spine Acapella (K171489), Osseus Red Ruby (K122008), Centinel Spine STALIF-C (K072415, K120819, K142079, K150053), Stryker Spine Anchor-C (K102606), Spinal Elements Mosaic-C (K133218, K071833), Renovis Tesera SC (K153250), NuVasive CoRoent Small Interlock II (K170961), and the Zimmer Trabecular Metal Fusion Device (K103033, K111119).
Device Description
The Stable-C Interbody System is an anterior cervical interbody device comprised of a cage (lordotic angles of 0 , 6°, and 12°) made from Ti-6Al-4V per ASTM F3001 and two fixation anchors made from Ti-6-Al-4V ELI per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.
Indications for Use
The Stable-C Interbody System is an anterior cervical interbody fusion system. The Stable-C Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is to be used with supplemental fixation cleared for use in the cervical spine. The system is intended to be used with autogenous or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.
4
Technological Characteristics
The Stable-C Interbody System is manufactured using both subtractive and additive manufacturing. Predicate devices are machined from the same material. The Stable-C Interbody System is substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use, and operational principles.
Performance Data
Mechanical testing was performed to demonstrate that the Stable-C Interbody System is substantially equivalent to the predicate devices listed above. The following tests were performed:
- Static and dynamic compression testing per ASTM F2077 ●
- Static and dynamic compression-shear testing per ASTM F2077 ●
- Static and dynamic torsion testing per ASTM F2077
- Wear debris/mass change analysis during ASTM F2077, per ASTM 1877 and ASTM ● F1714.
- Expulsion testing. ●
- Equivalence rationale for subsidence per ASTM F2267. ●
- Custom static compression testing of the locking mechanism. ●
Conclusion
Documentation provided demonstrates the Stable-C Interbody System is substantially equivalent to predicate devices.