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Reliance Lumbar IBF System

by Reliance Medical Systems, LLC 5 variants

510(k) K113540

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 NumberK113540 Date12 Mar 2012ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

The Reliance Lumbar IBF System is an intervertebral body fusion device intended for use in skeletally mature patients. It is designed to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery to facilitate bone fusion between two contiguous vertebral bodies. The device is typically used in the treatment of degenerative disc disease and is intended for use with autogenous bone graft.

The system consists of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical implant made of non-bioabsorbable material. It is supplied as a sterile, single-use device for implantation in a surgical setting. The device received FDA 510(k) clearance under K113540 and is classified under product code MAX with Orthopedic panel review.

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Questions

AI-generated answers, 22 Sep 2026

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

  • What is the Reliance Lumbar IBF System used for?

    The Reliance Lumbar IBF System is intended for use in skeletally mature patients to facilitate bone fusion between two contiguous vertebral bodies after partial or total removal of an intervertebral disc during surgery. It is typically used in the treatment of degenerative disc disease and is designed to be implanted with autogenous bone graft to promote spinal fusion.

  • How is the Reliance Lumbar IBF System supplied and is it reusable?

    The device is supplied as a sterile, single-use implant for implantation in a surgical setting. It is not intended for reuse; each device is designed for one-time implantation only to maintain sterility and structural integrity, and reusing it could compromise patient safety and device performance.

  • What materials and design features does the Reliance Lumbar IBF System have?

    The system consists of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical implant made of non-bioabsorbable material. This design allows for bone ingrowth through the porous structure and provides mechanical stability via threading or fenestrations, while the hollow center can be packed with autogenous bone graft to enhance fusion.