# K133967: Interbody Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Aurora Spine
- Decided: Jan 31, 2014 after 38 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: 12 generations back to K003155 (2001). 61 ancestors in all.
227 later devices descend from it; 7 cite it directly.
0 of 289 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130573: Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif, Tyber Medical, LLC (2013) Summary page 2.

## Most influential descendants
- K143578: SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer (2016), 210 descendants of its own
- K161223: TransContinental® M Spacers and InterContinental® Plate-Spacers (2016), 117 descendants of its own
- K170157: INDEPENDENCE® Spacers (2017), 109 descendants of its own
- K181357: PATRIOT® Lumbar Spacers, SUSTAIN® Spacers (2018), 97 descendants of its own
- K173722: PATRIOT COLONIAL Spacer, SUSTAIN Spacer (2018), 94 descendants of its own

## Indications for use
Lumbar System Indications The Aurora Spine Interbody Fusion System devices are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirned by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-SI ). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine. Cervical System Indications The Aurora Spine Interbody Fusion System is indicated for use as an intervenebral body fusion device in skeletally mature patients with degenerative disc disease (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 six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T I) and are placed via an anterior approach using autogenous hone. When used as an interhody fusion device, supplemental fixation must be used.

Source page: https://510kreport.com/device/K133967
Methodology: https://510kreport.com/methodology