# K253151: Fule Interbody Fusion Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Fule Science & Technology Development Co., Ltd.
- Decided: Jun 15, 2026 after 262 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K841189 (1984). 128 ancestors in all.
No later device cites it as a predicate yet.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151726: AVS AL and AVS ALign PEEK Spacers, AVS PL  and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer, Stryker Corporation (2016) Summary page 6.
- K120486: Avs as Peek Spacer, Stryker Spine (2012) Summary page 6.
- K100089: Synthes T-Pal Spacer, Synthes Spine (2010) Summary page 6.
- K172828: Double Medical Cage System, Double Medical Technology, Inc. (2018) Summary page 6.

## Indications for use
Cervical Spine (C2–T1): The FULE Interbody Fusion Cage Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (DDD), defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies, at one level of the cervical spine with accompanying radicular symptoms. Patients should have undergone at least six weeks of non-operative treatment prior to surgery. The implants are intended to facilitate fusion in the cervical spine (C2–T1) and are placed via an anterior cervical approach, using autogenous bone graft. When used in the cervical spine, the FULE Interbody Fusion Cage Systems are not intended for stand-alone use and must be used with supplemental fixation systems that have been cleared by FDA for use in the cervical spine, such as anterior cervical plate and screw fixation systems. Lumbar Spine (L2–S1): The FULE Interbody Fusion Cage Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (DDD), defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies, at one or two contiguous levels of the lumbar spine (L2–S1). Patients should have undergone at least six months of non-operative treatment prior to surgery. These implants are intended to facilitate fusion in the lumbar spine and are placed via an oblique lumbar interbody fusion (OLIF), posterior lumbar interbody fusion (PLIF), or transforaminal lumbar interbody fusion (TLIF) approach, using autograft or allograft bone graft. When used in the lumbar spine, the FULE Interbody Fusion Cage Systems are not intended for stand-alone use and must be used with supplemental fixation systems that have been cleared by FDA for use in the lumbar/lumbosacral spine, such as posterior pedicle screw and rod fixation systems.

Source page: https://510kreport.com/device/K253151
Methodology: https://510kreport.com/methodology