# K151276: DePuy Synthes T-PAL Ti Spacer

- Pathway: 510(k) (Special)
- Applicant: Synthes USA Products, LLC
- Decided: Jun 18, 2015 after 36 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 1 generation back to K100089 (2010). 1 ancestor in all.
129 later devices descend from it; 2 cite it directly.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100089: Synthes T-Pal Spacer, Synthes Spine (2010) Summary page 4.

## Most influential descendants
- 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
- K191581: Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device (2020), 81 descendants of its own

## Indications for use
The DePuy Synthes T-PAL Ti Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacers should be packed with autogenous bone graft (i.e. autograft). 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. The T-PAL Spacers are intended to be used with DePuy Synthes supplemental fixation.

Source page: https://510kreport.com/device/K151276
Methodology: https://510kreport.com/methodology