Tectonic Cervical Plate System
by K2m, LLC
510(k) K051531
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK051531 | Date17 Oct 2005 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWQ
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Tectonic Cervical Plate System is an orthopedic spinal fixation device classified as a cervical plate and screw assembly. It is designed to provide mechanical stabilization and immobilization of cervical spine segments from C2 to C7, typically used as an adjunct to spinal fusion procedures.
This system is intended for surgical use by physicians in clinical settings and consists of titanium alloy cervical screws and plates available in various sizes to accommodate patient anatomy. The device is supplied sterile for single-use and holds FDA 510(k) clearance under the traditional review pathway, with a product code of KWQ. Components are engineered for internal fixation of the cervical spine.
Other devices from K2M, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of surgical procedures is the Tectonic Cervical Plate System intended to support, and why is it specifically designed for the cervical spine?
The Tectonic Cervical Plate System is designed as an adjunct to spinal fusion procedures to provide mechanical stabilization and immobilization of cervical spine segments from C2 to C7. It is specifically engineered for the cervical spine because its titanium alloy screws and plates are tailored to accommodate the unique anatomy and biomechanics of this region, ensuring secure fixation during recovery and fusion.
Is the Tectonic Cervical Plate System reusable, or is it intended for single-use only? How does this affect its sterility?
The Tectonic Cervical Plate System is supplied sterile and intended for single-use only. This design ensures patient safety by eliminating the risk of cross-contamination or degradation from repeated sterilization processes, which could compromise the integrity of the titanium alloy components over time.
What materials are used in the Tectonic Cervical Plate System, and why is this material choice important for spinal fixation?
The system is constructed from titanium alloy, a material chosen for its strength, biocompatibility, and resistance to corrosion. Titanium’s lightweight yet durable properties make it ideal for spinal fixation, as it minimizes stress shielding while providing reliable stability to support fusion and promote proper healing in the cervical spine.
How many sizes or models of the Tectonic Cervical Plate System are available, and what determines the selection of the appropriate size for a patient?
The system includes various sizes of titanium alloy screws and plates to accommodate different patient anatomies. The correct size is determined by preoperative imaging and surgical assessment to ensure proper alignment, load distribution, and secure fixation across the cervical spine segments (C2–C7), optimizing stability and fusion outcomes.