(279 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the spinal plating system, with no mention of AI or ML.
No
The device is described as a plating system intended for temporary stabilization of the anterior spine, implying a mechanical and supportive function rather than an active therapeutic or diagnostic intervention.
No
This device is a surgical implant (cervical plate and screws) used for stabilization during spinal fusions, not for diagnosing conditions.
No
The device description explicitly states it is comprised of cervical plates and screws, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Cervical Spine Truss System Plating Solution (CSTS-PS) is a system of plates and screws intended for anterior interbody screw fixation of the cervical spine. This is a surgical implant used directly within the body for structural support and stabilization.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's health status.
Therefore, the CSTS-PS is a medical device (specifically, a surgical implant), but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cervical Spine Truss System Plating Solution (CSTS-PS) is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1.
The Cervical Spine Truss System Plation (CSTS-PS) is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Cervical Spine Truss System Plating Solution (CSTS-PS) is comprised of cervical plates and screws. The cervical plates have a rotating locking tab for each double screw position to prevent back-out of the screw. The plates are available in 1-level, 3-level, 4-level, and 5-level configurations. Each plate is available in multiple lengths to accommodate varying patient anatomy. The screws are available in two diameters and various lengths. All CSTS-PS plates and screws are made from Ti6Al4V alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at levels C2-T1
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
4WEB has conducted static compression bending, dynamic compression bending, static torsion, and screw push out testing per ASTM F1717 and ASTM F543 on the subject device. All performance testing has met the acceptance criteria established in FDA Guidance Document, Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway., December 11, 2020. The CSTS-PS implants are MR Conditional per ASTM F2503.
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.
K131025, K203065, K173159, K190870
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
May 18, 2022
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services USA and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
4WEB Medical, Inc. % Richard Jansen President Silver Pine Consulting 3851 Mossy Oak Drive Fort Myers, Florida 33905
Re: K212527
Trade/Device Name: Cervical Spine Truss System Plating Solution (CSTS-PS) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ
Dear Richard Jansen:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 17, 2022. Specifically, FDA is updating the device name in the Indications for Use as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Colin O'Neill, OHT6: Office of Orthopedic Devices, colin.oneill@fda.hhs.gov.
Sincerely,
Colin O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
May 17, 2022
Image /page/1/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
4WEB Medical, Inc. % Richard Jansen President Silver Pine Consulting 3851 Mossv Oak Drive Fort Myers, Florida 33905
Re: K212527
Trade/Device Name: Cervical Spine Truss System Plating Solution (CSTS-PS) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 14, 2022 Received: April 18, 2022
Dear Richard Jansen:
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
2
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,
Colin O'neill -S
Colin O'Neill, M.B.E. 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
3
Indications for Use
510(k) Number (if known) K212527
Device Name
Cervical Spine Truss System Plating Solution (CSTS-PS)
Indications for Use (Describe)
The Cervical Spine Truss System Plating Solution (CSTS-PS) is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1.
The Cervical Spine Truss System Plation (CSTS-PS) is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
| Date Prepared: | April 12, 2022 |
|---|---|
| Contact: | Jessee Hunt, President |
| 4WEB, Inc. | |
| 2801 Network Blvd., Suite 620 | |
| Frisco, TX 75034 | |
| Phone: (800) 285-7090 | |
| Fax: 972-488-1816 | |
| Regulatory Contact: | Rich Jansen, Pharm. D. |
| Silver Pine Consulting, LLC | |
| richj@s-pineconsulting.com | |
| Trade Name: | Cervical Spine Truss System Plating Solution (CSTS-PS) |
| Product Class: | Class II |
| Classification: | 21 CFR §888.3060 |
| Common Name: | Spinal intervertebral body fixation orthosis |
| Product Codes: | KWQ |
Indications for Use:
The Cervical Spine Truss System Plating Solution (CSTS-PS) is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1.
The Cervical Spine Truss System Plating Solution (CSTS-PS) is indicated for use in temporary stabilization of the anterior spine during the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Device Description:
The Cervical Spine Truss System Plating Solution (CSTS-PS) is comprised of cervical plates and screws. The cervical plates have a rotating locking tab for each double screw position to prevent back-out of the screw. The plates are available in 1-level, 3-level, 4-level, and 5-level configurations. Each plate is available in multiple lengths to accommodate varying patient anatomy. The screws are available in two diameters and various lengths. All CSTS-PS plates and screws are made from Ti6Al4V alloy.
5
Predicate Device(s):
The primary predicate device is the Nuvasive Archon Anterior Cervical Plate System (K131025). Additional predicates include the 4WEB Lumbar Spine Truss System Plating Solution (K203065), 4WEB Cervical Spine Truss System (K173159), and 4WEB Cervical Spine Truss System-Stand Alone (K190870).
Performance Standards:
4WEB has conducted static compression bending, dynamic compression bending, static torsion, and screw push out testing per ASTM F1717 and ASTM F543 on the subject device. All performance testing has met the acceptance criteria established in FDA Guidance Document, Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway., December 11, 2020. The CSTS-PS implants are MR Conditional per ASTM F2503.
Technological Characteristics:
4WEB, Inc. has compared these devices to the previously cleared predicate devices in regard to indications for use, materials, function, sizes and simulated testing. These comparisons demonstrate substantial equivalence to the predicate devices.
Conclusion:
4WEB, Inc. concludes that the CSTS-PS devices are substantially equivalent to the predicate devices and raise no new questions of safety or effectiveness.