# K110915: Cervical Cage

- Pathway: 510(k) (Abbreviated)
- Applicant: Eisertech, LLC
- Decided: Jul 22, 2011 after 112 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: 12 generations back to K003155 (2001). 43 ancestors in all.
23 later devices descend from it; 1 cites it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083311: Aesculap Cespace Peek Intervertebral Body Fusion System, Aesculap Implant Systems, Inc. (2009) Summary page 1.
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 1.
- K082848: Nubic and Rabea Devices, Signus Medizintechnik GmbH (2009) Summary page 1.
- K081611: Nuvasive Coroent System, Nuvasive, Inc. (2008) Summary page 1.
- K081730: Novel Cervical Spinal Spacer System, Alphatec Spine, Inc. (2008) Summary page 1.

## Most influential descendants
- K122444: Cervical Cage (2012), 22 descendants of its own
- K173347: STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX (2018), 12 descendants of its own
- K181115: CxHA PEEK Cervical IBF System (2018), 8 descendants of its own
- K220875: HAcancellous PEEK-C Porous HA PEEK Cervical IBF System (2022), 4 descendants of its own
- K201453: Fortilink Cages with TiPlus Technology (2020), 4 descendants of its own

## Indications for use
The Cervical Cage is intended for spinal fusion procedures at one level (C2 to Ti) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Cervical Cage is intended to be used with a supplemental fixation system.

Source page: https://510kreport.com/device/K110915
Methodology: https://510kreport.com/methodology