TiLock2 Spinal System
510(k) K152039
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152039 | Date28 Oct 2015 | 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- Withdrawn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
- Full name
- Genesys Spine TiLock2 Spinal System
- 510(k) Number
- FDA Product Code
- NKB
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The TiLock2 Spinal System is a modular orthopedic implant designed for posterior spinal fixation and stabilization. It includes pedicle screws, reduction screws, minimally invasive (MIS) screws, cross-links, hooks, offset connectors, and rod-to-rod connectors. These components are intended for use in open and minimally invasive surgical procedures to address thoracolumbar spine instability or deformity. The system is classified under the product code NKB and is intended for spinal stabilization applications.
The TiLock2 Spinal System is supplied as a reusable set of surgical implants, requiring sterilization before use. It is intended for use in operating room settings by orthopedic surgeons. The system is regulated under the FDA’s 510(k) pathway, with clearance granted as substantially equivalent to a predicate device. No specific sterility or single-use designation is stated in the data, though implants must be sterilized prior to surgical use. Sizes and configurations vary based on anatomical requirements and surgical approach.
Other devices from Genesys Spine
Questions
AI-generated answers, 1 Oct 2026
What is the TiLock2 Spinal System used for?
The TiLock2 Spinal System is designed for posterior spinal fixation and stabilization in open or minimally invasive surgical procedures. It addresses thoracolumbar spine instability or deformity by providing secure attachment through pedicle screws, reduction screws, minimally invasive screws, cross-links, hooks, and connectors. The modular components allow customization to fit specific anatomical and surgical needs.
How is the TiLock2 Spinal System supplied and prepared for use?
The TiLock2 Spinal System is supplied as a reusable set of surgical implants. Before use, all components must be sterilized to ensure safety and efficacy in the operating room. This sterilization process is the responsibility of the surgical facility prior to surgery.
Is the TiLock2 Spinal System single-use or reusable?
The TiLock2 Spinal System is intended for reuse after proper sterilization. Unlike single-use devices, this system is designed to be cleaned, sterilized, and used multiple times in different procedures, provided it meets the facility’s sterilization protocols and remains in good condition.
What types of components are included in the TiLock2 Spinal System?
The system includes a variety of components such as pedicle screws, reduction screws, minimally invasive (MIS) screws, cross-links, hooks, offset connectors, and rod-to-rod connectors. These modular parts allow surgeons to tailor the system to the specific anatomical and surgical requirements of the patient, ensuring flexibility in both open and minimally invasive procedures.
How is the regulatory status of the TiLock2 Spinal System determined?
The TiLock2 Spinal System has received FDA clearance through the 510(k) pathway, specifically under the Traditional review process. It was determined to be substantially equivalent to a predicate device, meaning it meets the same performance standards and safety requirements as an existing, cleared device in the same product category (NKB). This clearance ensures compliance with U.S. regulatory standards for spinal fixation systems.