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Lucent - Lucent

by Spinal Elements, Inc.

510(k) K150061

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK150061 Date19 May 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MAX
Models / Variants
Lucent
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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.