# K150847: Foundation Interbody Devices

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: Aug 13, 2015 after 135 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: 13 generations back to K841189 (1984). 88 ancestors in all.
29 later devices descend from it; 4 cite it directly.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073440: Foundation Cage, Corelink, LLC (2008) Summary page 4.
- K081614: Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar Cages, Interbody Innovations, Llp (2008) Summary page 4.
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems, Depuy Spine, Inc. (2009) Summary page 4.
- K094025: Crescent Spinal System, Medtronic Sofamor Danek (2010) Summary page 4.
- K133216: Crescent Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 4.
- K073144: Lanx Intervertebral Body Fusion Device, Lanx, LLC (2008) Summary page 4.
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 4.
- K130573: Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif, Tyber Medical, LLC (2013) Summary page 4.

## Most influential descendants
- K180814: CoreLink® M3™ Stand-Alone Anterior Lumbar System (2018), 18 descendants of its own
- K192492: EL CAPITAN Anterior Lumber Interbody System (2020), 10 descendants of its own
- K183239: CoreLink F3D™ Lateral System (2018), 8 descendants of its own
- K222554: EL CAPITAN Anterior Lumbar Interbody Fusion (2023), 5 descendants of its own
- K180556: Corelink Foundation 3D Anterior Lumbar System (2018), 5 descendants of its own

## Indications for use
Foundation™ Cervical Interbody Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation™ Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation Cervical implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage The Foundation™ Lumbar Interbody Devices are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ Lumbar implants 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/K150847
Methodology: https://510kreport.com/methodology