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Innesis PEEK TL Cage

FDA 510(k)

Class II (US FDA 510(k))

510(k) K140577

by Bk Meditech Co., Ltd.

Identifiers

510(k) Number
K140577 FDA 510(k)
FDA Product Code
MAX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is a hollow, porous, threaded and/or fenestrated cylindrical or geometrical intervertebral body fusion cage made of non-bioabsorbable synthetic polymer, specifically polyetheretherketone (PEEK). It provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur, with bone graft typically used to support osseointegration.

It is indicated for intervertebral body fusion of the lumbar spine from L2 to S1 in skeletally mature patients who have undergone six months of non-operative treatment. The device is supplied in various sizes, including model numbers such as 46208 and 52830-31, and is authorized under FDA 510(k) clearance K140577. It is intended for use in surgical settings as an implantable device for spinal fusion procedures.

Frequently asked questions

What is the INNESIS PEEK TL Cage used for?

The INNESIS PEEK TL Cage is indicated for intervertebral body fusion of the lumbar spine from L2 to S1 in skeletally mature patients who have failed six months of non-operative treatment. It provides mechanical stability and space for bone graft to support spinal fusion.

What material is the INNESIS PEEK TL Cage made of and what are its structural features?

The device is made of non-bioabsorbable polyetheretherketone (PEEK) and is designed as a hollow, porous, threaded and/or fenestrated cylindrical or geometrical intervertebral body fusion cage to allow bone graft placement and promote osseointegration.

How is the INNESIS PEEK TL Cage supplied and what sizes or models are available?

The INNESIS PEEK TL Cage is supplied in various sizes for surgical implantation, with specific model numbers including 46208 and 52830-31, as indicated in the device authorization data.

Is the INNESIS PEEK TL Cage intended for single-use or reuse?

The INNESIS PEEK TL Cage is an implantable device intended for single-use in spinal fusion procedures; as a permanent implant, it is not designed for removal or reuse after surgical placement.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: INNESIS PEEK TL CAGE (K140577) — FDA 510 (k) | Innolitics, Innesis Peek Tl Cage - Beudamed, AccessGUDID - DEVICE: INNESIS PEEK TL CAGE (08809228124367), INNESIS PEEK TL CAGE 52830-31 Trial(D0W10L28H11)… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bk Meditech Co., Ltd.
FDA Applicant
Bk Meditech, Co., Ltd.

Sources (1)

  • FDA 510(k) K140577 24 fields · synced Sep 25, 2026