# K151322: Amendia Interbody Fusion Devices

- Pathway: 510(k) (Traditional)
- Applicant: Amendia, Inc.
- Decided: Sep 10, 2015 after 115 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K841189 (1984). 136 ancestors in all.
226 later devices descend from it; 6 cite it directly.
0 of 363 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081614: Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar Cages, Interbody Innovations, Llp (2008) Summary page 4.
- K141665: NuVasive CoRoent System, Nuvasive, Inc. (2015) Summary page 4.
- K142264: Valeo C Spacer System, Valeo II C IBF Device, Amedica Corp. (2014) Summary page 4.

## Most influential descendants
- K151310: Amendia Interbody Fusion Devices (2016), 169 descendants of its own
- K160924: Amendia Interbody Fusion Devices (2016), 166 descendants of its own
- K171496: Tritanium C Anterior Cervical Cage (2017), 129 descendants of its own
- K180364: HD LifeSciences Cervical IBFD System (2018), 106 descendants of its own
- K183557: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (2019), 104 descendants of its own

## Recalls of this device
- Nov 22, 2016 · Class II · Z-0827-2017: Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label matched the lab

## Indications for use
The Amendia Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Amendia Cervical Interbody Fusion Devices are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone and supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level 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. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K151322
Methodology: https://510kreport.com/methodology