LITe Plate System
510(k) K150449
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k) | NumberK150449 | Date20 Mar 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- Withdrawn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
- 510(k) Number
- FDA product code
- KWQ
- FDA applicant
- Stryker Corporation
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The LITe Plate System is an orthopedic fixation device designed for spinal stabilization. It features a spring-loaded bar mechanism that automatically locks over screw heads upon insertion, providing secure fixation with visual and tactile confirmation. The system incorporates a secondary blocker for added stability, ensuring proper alignment and support during spinal procedures. It is categorized under orthopedic implants and is intended for use in spinal surgeries requiring rigid fixation.
The LITe Plate System is supplied as a reusable surgical instrument set, intended for use in controlled clinical environments such as operating rooms. It includes plates with screw sizes ranging from 5.0/5.5mm and lengths of 40mm to 60mm, tailored for lumbar spinal fixation. The device is regulated under FDA 510(k) clearance (K142699) and adheres to traditional review standards. Sterility and handling instructions must be followed as per manufacturer guidelines, and its use requires adherence to standard surgical protocols and aseptic techniques.
Other devices from Stryker Corp.
Questions
AI-generated answers, 20 Sep 2026
What types of spinal surgeries is the LITe Plate System designed for, and how does its spring-loaded mechanism improve fixation stability?
The LITe Plate System is specifically designed for lumbar spinal fixation during surgeries requiring rigid stabilization. Its spring-loaded bar mechanism automatically locks over screw heads upon insertion, providing secure fixation with both visual and tactile confirmation. This ensures immediate stability and proper alignment, reducing the risk of loosening or misalignment during the procedure.
Is the LITe Plate System intended for single-use or reusable applications, and what screw sizes and plate lengths are available?
The LITe Plate System is supplied as a reusable surgical instrument set, intended for use in controlled environments like operating rooms. It includes plates with screw sizes of 5.0mm and 5.5mm, and lengths ranging from 40mm to 60mm, tailored for lumbar spinal fixation.
How does the secondary blocker in the LITe Plate System contribute to its overall stability during spinal procedures?
The secondary blocker in the LITe Plate System acts as an additional safety feature, ensuring proper alignment and support of the fixation hardware. It helps prevent unintended movement of screws or plates, reinforcing the primary locking mechanism and enhancing overall stability during spinal surgeries.
What regulatory pathway was followed for FDA clearance of the LITe Plate System, and what does this mean for its use in clinical settings?
The LITe Plate System received FDA 510(k) clearance (K142699) under the Traditional Review pathway, categorized under orthopedic implants (Product Code: KWQ). This means it was determined to be substantially equivalent to a legally marketed device, allowing its use in clinical settings while adhering to standard surgical protocols and aseptic techniques as outlined by the manufacturer.