Lucent Ti-Bond Systems
510(k) K150061
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150061 | Date19 May 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- Withdrawn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
- Lucent; Lucent Ti-Bond Systems
- 510(k) Number
- FDA product code
- MAX
- Models / Variants
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Lucent Ti-Bond Systems are interbody fusion devices designed for posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) procedures. Constructed from radiolucent PEEK-OPTIMA®, these implants feature a titanium porous coating (Ti-Bond) to enhance osseointegration and stability. The system includes anatomically shaped cages available in varying heights and configurations to accommodate different spinal anatomies and surgical approaches.
Supplied as a reusable surgical instrument set, the Lucent Ti-Bond Systems are intended for use in orthopedic spine surgery under sterile conditions. The devices are not single-use and require proper sterilization between procedures. They are MRI-safe and comply with FDA 510(k) clearance under the Traditional pathway (K150061). Storage and handling must adhere to manufacturer guidelines to maintain sterility and structural integrity.
Other devices from Spinal Elements, Inc.
Questions
AI-generated answers, 1 Oct 2026
What procedures are the Lucent Ti-Bond Systems designed for?
The Lucent Ti-Bond Systems are specifically engineered for posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) procedures. Their anatomically shaped cages and titanium porous coating are optimized to provide stability and promote osseointegration in these spinal fusion surgeries.
How are the Lucent Ti-Bond Systems supplied, and are they single-use?
The Lucent Ti-Bond Systems are supplied as a reusable surgical instrument set. They are not designed for single-use and must be properly sterilized between procedures to maintain safety and functionality. Sterilization protocols must follow manufacturer guidelines to preserve sterility and structural integrity.
What material is used in the Lucent Ti-Bond Systems, and why?
The cages in the Lucent Ti-Bond Systems are constructed from radiolucent PEEK-OPTIMA®, a material chosen for its radiolucency and biocompatibility. The titanium porous coating (Ti-Bond) is added to enhance osseointegration, improving the stability and integration of the implant with the surrounding bone during spinal fusion.
Are the Lucent Ti-Bond Systems compatible with MRI imaging?
Yes, the Lucent Ti-Bond Systems are MRI-safe. This compatibility allows for post-operative MRI imaging without interference from the implant, which is particularly useful for monitoring spinal fusion progress or diagnosing related conditions.
What storage and handling guidelines should be followed for the Lucent Ti-Bond Systems?
To maintain sterility and structural integrity, the Lucent Ti-Bond Systems must be stored and handled according to the manufacturer’s guidelines. Proper storage conditions prevent contamination and ensure the devices remain functional for repeated use, as they are not single-use items.