(165 days)
No
The summary describes a physical implantable device (cervical cage and screws) and its mechanical properties. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device is an interbody cage designed to facilitate fusion in anterior cervical interbody fusion procedures for patients with cervical disc disease, indicating a direct therapeutic action on a medical condition.
No
The device is an interbody fusion device, not a diagnostic device. It is used in surgical procedures to facilitate fusion, not to diagnose a condition.
No
The device description clearly states it is an interbody device made of PEEK and Titanium, including screws and radiographic markers. This indicates it is a physical implant, not a software-only device.
Based on the provided information, the Romero Cervical Cage is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Romero Cervical Cage Function: The Romero Cervical Cage is an implantable medical device designed to be surgically placed in the cervical spine to facilitate bone fusion. It is a physical device used in the body, not a tool for analyzing samples from the body.
- Intended Use: The intended use clearly describes a surgical procedure and the purpose of the implant in that procedure. It does not involve any analysis of biological specimens.
- Device Description: The description details the materials, dimensions, and features of a physical implant and associated screws.
- Performance Studies: The performance studies focus on mechanical testing of the device's structural integrity and stability, not on the accuracy or reliability of diagnostic results from biological samples.
Therefore, the Romero Cervical Cage falls under the category of an implantable surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Romero Cervical Cage consists of an interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one or two contiguous levels from the C2 to the T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Romero Cervical Cage includes cages with and without screw holes. For cages with internal screw holes, the provided screws must be used for internal fixation. The Romero Cervical Cage requires additional supplemental fixation cleared for the cervical spine. The Romero Cervical Cage is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Product codes
OVE, ODP
Device Description
The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK HA or PEEK OPTIMA interbody cage with tantalum radiographic markers and two Titanium (Ti-6Al-4V ELI) fixation screws for cages with screw holes. The PEEK material used conforms to ASTM F2026, the Titanium screws conforms to ASTM F136 and the Tantalum radiographic markers conforms to ASTM F560. The interbody cage is provided in 6° lordosis, anatomic (domed), and lordotic (tapered) profiles in footprints ranging from (WxD) 14x12 to 20x16 (by increments of 2 mm in either direction) and sizes ranging from 5.5 mm (H04) to 14.5 mm (H13) (excluding H04 and H05 in the (WxD) 14x12 to 14x16 footprint for the self-anchored cages). The two radiographic markers are present on the posterior wall to confirm position and orientation relative to the AP plane. The bone screws are provided as self-drilling and self-tapping options in 3.5 mm and 4.0 mm diameters and 8-20 mm lengths and feature an anti-backout / tri-lobe screw head design. Both cages and screws are available in separate, single-use sterile packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2 to the T1 disc
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: static compression, static compression shear, static torsion, dynamic compression, dynamic compression shear, and dynamic torsion testing per ASTM F2077-18. Subsidence testing per ASTM F2267-04, expulsion and axial push out testing.
The result showed that the worst-case constructs were substantially equivalent to legally marketed devices. No clinical or animal studies were performed.
Key Metrics
Not Found
Predicate Device(s)
K141599, K173102, K202812, K142079
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
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January 10, 2022
SpineUp Inc. Ryan Weitzel VP of Quality Assurance & Regulatory Affairs 100 North Biscayne Blvd. Suite 3070 Miami, Florida 33132
Re: K212358
Trade/Device Name: Romero Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE, ODP Dated: December 10, 2021 Received: December 13, 2021
Dear Ryan Weitzel:
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
1
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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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 Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212358
Device Name Romero Cervical Cage
Indications for Use (Describe)
The Romero Cervical Cage consists of an interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one or two contiguous levels from the C2 to the T1 disc. Cervical disc disease is defined as intractable radior myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal confirmed by radiographic studies. The Romero Cervical Cage includes cages with and without screw holes. For cages with internal screw holes, the provided screws must be used for internal fixation. The Romero Cervical Cage requires additional supplemental fixation cleared for the cervical spine. The Romero Cervical Cage is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Submitter's Name: | SpineUp, Inc |
|---|---|
| Submitter's Address: | 100 North Biscayne Blvd |
| Suite 3070 | |
| Miami, FL 33132 | |
| Submitter's Telephone: | (786) 910-0234 |
| Company Contact Person: | Philippe Laurito |
| Contact Person: | Ryan Weitzel |
| VP of Quality Assurance and Regulatory Affairs | |
| ryan.w@upgroup.tech | |
| Date Summary was Prepared: | 1/7/2022 |
| Trade or Proprietary Name: | Romero Cervical Cage |
| Common or Usual Name: | Intervertebral body fusion device |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | OVE, ODP |
| Classification Panel: | Division of Orthopedic Devices |
| Panel Code: | 87 |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK HA or PEEK OPTIMA interbody cage with tantalum radiographic markers and two Titanium (Ti-6Al-4V ELI) fixation screws for cages with screw holes. The PEEK material used conforms to ASTM F2026, the Titanium screws conforms to ASTM F136 and the Tantalum radiographic markers conforms to ASTM F560. The interbody cage is provided in 6° lordosis, anatomic (domed), and lordotic (tapered) profiles in footprints ranging from (WxD) 14x12 to 20x16 (by increments of 2 mm in either direction) and sizes ranging from 5.5 mm (H04) to 14.5 mm (H13) (excluding H04 and H05 in the (WxD) 14x12 to 14x16 footprint for the self-anchored cages). The two radiographic markers are present on the posterior wall to confirm position and orientation relative to the AP plane. The bone screws are provided as self-drilling and self-tapping options in 3.5 mm and 4.0 mm diameters and 8-20 mm lengths and feature an anti-backout / tri-lobe screw head design. Both cages and screws are available in separate, single-use sterile packaging.
INDICATIONS FOR USE ROMERO CERVICAL CAGE
The Romero Cervical Cage consists of an interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one or two contiguous levels from the C2 to the T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Romero Cervical Cage includes cages with and without screw holes. For cages with internal screw holes, the provided screws must be used for internal fixation. The Romero Cervical Cage requires additional supplemental fixation cleared for the cervical spine. The Romero Cervical Cage is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
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PREDICATES
Romero Cervical Cage is substantially equivalent to the Medtronic DIVERGENCE™ Anterior Cervical Fusion System (K141599). The Romero Cervical Cage is provided sterile. The subject and predicate devices have identical technological characteristics. Specifically, the following characteristics are identical between the subject and predicates:
- Indications for Use (equivalent to Primary and Additional predicates) ●
- Materials of manufacture (combination of Primary predicate and FDA MAF references)
- Structural support mechanism (identical to Additional Predicate)
| 510k
Number | Trade or
Proprietary or
Model Name | Manufacturer | Type |
|-------------------------|------------------------------------------------------|--------------------------------------|-------------------------------------------------|
| K141599
(Primary) | DIVERGENCE™
Anterior Cervical
Fusion System | Medtronic Sofamor
Danek USA, Inc. | OVE - Intervertebral body fusion
device |
| K173102
(Additional) | Reliance Cervical
IBF System | Reliance Medical
Systems, LLC | ODP, OVE - Intervertebral body
fusion device |
| K202812
(Additional) | IdentiTi™ Cervical
Standalone Interbody
System | Alphatec Spine, Inc. | OVE - Intervertebral body fusion
device |
| K142079
(Additional) | STALIF C® | Centinel Spine, Inc. | OVE - Intervertebral body fusion
device |
Table 6-1: Predicate Devices
PERFORMANCE TESTING
SpineUp's Romero Cervical Cage was evaluated to demonstrate equivalence to the primary predicate device as well as the additional predicates for features that were being combined in the new device. Mechanical testing was performed to demonstrate substantial equivalence using static compression, static compression shear, static torsion, dynamic compression, dynamic compression shear, and dynamic torsion testing per ASTM F2077-18. Subsidence testing per ASTM F2267-04, expulsion and axial push out testing.
The result showed that the worst-case constructs were substantially equivalent to legally marketed devices. No clinical or animal studies were performed.
CONCLUSION
SpineUp concludes that the Romero Cervical Cage is substantially equivalent to the already marketed predicate in regard to indications for use, materials, function, sizes and mechanical test results.