# K092901: Epicage Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: R Tree Innovations
- Decided: Apr 28, 2010 after 219 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: 1 generation back to P950002 (1996). 4 ancestors in all.
609 later devices descend from it; 3 cite it directly.
1 of 614 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 1.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 1.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K082262: LDR Spine Roi Interbody Fusion System, Ldr Spine USA (2009) Summary page 1.

## Most influential descendants
- K130548: Epicage Interbody Fusion Device (2013), 602 descendants of its own
- K132601: Coroent Sterile Implants System (2013), 596 descendants of its own
- K140319: Coroent TI-C System (2014), 590 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K140659: Coroent Thoracolumbar Implants (2014), 483 descendants of its own

## Indications for use
The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device is intended to be used with supplemental posterior fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

Source page: https://510kreport.com/device/K092901
Methodology: https://510kreport.com/methodology