# K132483: Innesis Peek Cervical Cage

- Pathway: 510(k) (Traditional)
- Applicant: Bk Meditech, Co., Ltd.
- Decided: Apr 2, 2014 after 237 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 14 generations back to K003155 (2001). 124 ancestors in all.
No later device cites it as a predicate yet.
1 of 125 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120464: Innesis Peek Cage, Bk Meditech, Co., Ltd. (2013) Summary page 2.
- K120486: Avs as Peek Spacer, Stryker Spine (2012) Summary page 2.
- K130948: C-Fuse Cervical Intervertebral Body Fusion System, Southern Spine, LLC (2013). Cleared while this submission was under review Summary page 2.
- K090887: Orio-C Cervical, Orio-TL Tlif, Orio-PL Plif, Orio-AL Alif Intervedrtebral Body Fusion Cages, SpineCraft (2009) Summary page 2.
- K112862: Mecta-C, Medacta International (2011) Summary page 2.
- K092904: Pathway Ivb/VBR, Custom Spine, Inc. (2009) Summary page 2.
- K092336: C-Thru Spinal System, Ebi, L.P. (2009) Summary page 2.
- K111820: Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage, Bm Korea Co., Ltd. (2012)
- K072226: Impix Spacer, Medicrea Technologies (2007) Summary page 2.

## Indications for use
The INNESIS PEEK Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T 1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. INNESIS PEEK Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach and packed with autogenous bone. INNESIS PEEK Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K132483
Methodology: https://510kreport.com/methodology