Synthes Titanium Locking Plate System (TiLPS)
by Synthes (Usa) 510(k)
Active
510(k) K970048
Overview
The Synthes Titanium Locking Plate System (TiLPS) is a spinal fixation device classified as an Appliance, Fixation, Spinal Intervertebral Body (Product Code: KWQ). It consists of a two-hole commercially pure titanium plate designed for anterior spinal stabilization, supplemented by 4.35 mm expansion screws and 1.8 mm locking screws. This system provides structural support and buttressing for bone grafts across a single motion segment in the L1-S1 region of the spine. Its locking mechanism ensures secure fixation, enhancing stability during the healing process.
The TiLPS is intended for surgical use in orthopedic settings and is supplied sterile for single-use applications. The system is MRI-unsafe due to its metallic components and must be handled according to standard orthopedic surgical protocols. Storage requires protection from moisture and physical damage. Authorized under FDA 510(k) clearance (K970048), the device was reviewed by the Orthopedic (OR) Advisory Committee in 1997 and classified as substantially equivalent to predicate devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK970048 | Date1 Aug 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Synthes(USA)Titanium Locking Plate System(Tilps)
- 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
Other devices from Synthes (Usa)
Questions
What is the TiLPS Titanium Locking Plate System used for?
The TiLPS Titanium Locking Plate System is designed for anterior spinal stabilization in the L1-S1 region of the spine. It provides structural support and buttressing for bone grafts across a single motion segment, ensuring secure fixation to enhance stability during the healing process. This is particularly useful in orthopedic surgeries requiring controlled spinal alignment.
How is the TiLPS system supplied and intended for use?
The TiLPS system is supplied sterile and is intended for single-use applications only. It adheres to standard orthopedic surgical protocols, ensuring safety and efficacy in clinical settings. The sterile packaging protects the device until immediate preoperative use.
Is the TiLPS system safe for MRI procedures?
No, the TiLPS system is not MRI-safe due to its metallic titanium components. Patients with this device implanted should avoid MRI scans to prevent potential complications such as heating or displacement of the hardware.
What storage conditions are required for the TiLPS system?
The TiLPS system must be stored in a protected environment to prevent exposure to moisture and physical damage. Proper storage ensures the integrity of the device and maintains its sterility until use. Follow manufacturer guidelines for optimal storage practices.
What are the key components of the TiLPS system?
The TiLPS system consists of a two-hole commercially pure titanium plate, 4.35 mm expansion screws, and 1.8 mm locking screws. These components work together to provide secure fixation and stability during spinal fusion procedures in the L1-S1 region.