# K131276: Lateral Synfix

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Jan 6, 2014 after 245 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: 14 generations back to K841189 (1984). 83 ancestors in all.
146 later devices descend from it; 4 cite it directly.
0 of 230 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 1.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 1.
- K121982: Sovereign Spinal System, Medtronic Sofamor Danek (2012) Summary page 1.
- K103382: Intercontinental Plate-Spacer, Globus Medical, Inc. (2011) Summary page 1.
- K123180: Falcon Spacer, Synthes (USA) Products, LLC (2013) Summary page 1.

## Most influential descendants
- K150673: SYNFIX Evolution Secured Spacer System (2015), 137 descendants of its own
- K162358: T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System (2016), 127 descendants of its own
- K171689: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System  with TiONIC Technology (2017), 109 descendants of its own
- K190959: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology (2019), 108 descendants of its own
- K192018: Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic 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 (2019), 102 descendants of its own

## Indications for use
The SYNFIX Lateral is a stand-alone lateral lumbar interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. The interior of the SYNFIX Lateral spacer component should be packed with autogenous bone graft (i.e. autograft); all four screws must be used when implanting this device. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment

Source page: https://510kreport.com/device/K131276
Methodology: https://510kreport.com/methodology