# K152943: NuVasive Foundation-LL System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Dec 1, 2015 after 57 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 17 generations back to K841189 (1984). 124 ancestors in all.
187 later devices descend from it; 3 cite it directly.
0 of 312 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151214: ALIF Interfixated System, Nu Vasive, Incorporated (2015) Summary page 4.
- K123045: Brigade Standalone System, Nuvasive, Inc. (2013) Summary page 4.
- K140319: Coroent TI-C System, Nuvasive, Inc. (2014) Summary page 4.
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 4.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 4.

## Most influential descendants
- K170592: NuVasive BASE Interfixated Titanium System (2017), 186 descendants of its own
- K193593: NuVasive 3DP Interfixated ALIF System (2020), 157 descendants of its own
- K201820: NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System (2020), 156 descendants of its own
- K203201: NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System (2021), 94 descendants of its own
- K211258: Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System (2021), 75 descendants of its own

## Indications for use
The Foundation-LL System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The Foundation-LL System is intended for use with autograft. The Foundation-LL System must be used with supplemental internal spinal fixation systems (i.e., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Foundation-LL System.

Source page: https://510kreport.com/device/K152943
Methodology: https://510kreport.com/methodology