# K120464: Innesis Peek Cage

- Pathway: 510(k) (Traditional)
- Applicant: Bk Meditech, Co., Ltd.
- Decided: Jan 18, 2013 after 338 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: 8 generations back to K003155 (2001). 27 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050624: Stryker Spine Avs PL Peek Spacer, Stryker Spine (2005) Summary page 1.
- K092162: 4CIS Peek, Plif and Tlif Cage System, Solco Biomedical Co., Ltd. (2010) Summary page 1.
- K110067: LP Cage, Medyssey Co, Ltd. (2011)

## Most influential descendants
- K140577: Innesis Peek TL Cage (2014), 2 descendants of its own
- K172756: Varian cage (2017), 1 descendant of its own
- K123607: Octane Elevate Spinal Implant System (2014), 1 descendant of its own
- K220953: ChoiceSpine TigerShark™ M, Modular Interbody System (2022), 0 descendants of its own
- K203327: VERTACONNECT TLIF Cage (2021), 0 descendants of its own

## Indications for use
The INNESIS PEEK Cages wre indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-SI. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. INNESIS PEEK Cages are to be used with autogenous bone graft and implanted via a posterior approach. The INNESIS PEEK Cages are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K120464
Methodology: https://510kreport.com/methodology