# K120074: Foundation Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: The Skeletal Design Partnership, Ltd.
- Decided: Mar 14, 2012 after 64 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K901587 (1990). 32 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971248: Kaneda SR Anterior Spinal System, Acromed Corp. (1997) Summary page 2.
- K031655: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2003) Summary page 2.
- K041460: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2004) Summary page 2.
- K041119: Expedium Spine System, Depuy Spine, Inc. (2004) Summary page 2.
- K051024: Expedium Spine System, Depuy Spine, Inc. (2005) Summary page 2.
- K992168: Moss Miami 6.35MM Polyaxial Screw, Depuyacromed (1999) Summary page 2.
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 2.
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 2.
- K974749: Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems, Cross Medical Products, Inc. (1998) Summary page 2.

## Most influential descendants
- K151770: Libra Pedicle Screw System (2015), 1 descendant of its own
- K162750: Libra Pedicle Screw System (2016), 0 descendants of its own

## Indications for use
The Foundation Spinal System is intended for thoracolumbar (T4-L4) anterolateral screw fixation and posterior, non-cervical (Ti-Si) pedicle and non-pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

Source page: https://510kreport.com/device/K120074
Methodology: https://510kreport.com/methodology