# K130548: Epicage Interbody Fusion Device

- Pathway: 510(k) (Special)
- Applicant: Alphatec Spine, Inc.
- Decided: Apr 18, 2013 after 45 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: 2 generations back to P950002 (1996). 5 ancestors in all.
602 later devices descend from it; 3 cite it directly.
1 of 608 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092901: Epicage Interbody Fusion Device, R Tree Innovations (2010) Summary page 2.

## Most influential descendants
- 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
- K141896: Coroent System (2014), 480 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-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(s). It is indicated to be used with autograft bone. Patients should have received six months of non-operative treatment prior to treatment with the devices. The device is intended to be used with supplemental posterior fixation approved for use in the lumbar spine such as Aiphatec Spine's Zodiac Polyaxial Spinal Fixation System and/or Illico Posterior Fixation System.

Source page: https://510kreport.com/device/K130548
Methodology: https://510kreport.com/methodology