# K181231: DePuy Synthes T-PAL Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Synthes Spine
- Decided: Dec 6, 2018 after 211 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: 2 generations back to K100089 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K151276: DePuy Synthes T-PAL Ti Spacer, Synthes USA Products, LLC (2015) Summary page 4.

## Indications for use
The T-PAL 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 Spacer 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 nonoperative treatment. The T-PAL Spacer is intended to be used with DePuy Synthes supplemental fixation.

Source page: https://510kreport.com/device/K181231
Methodology: https://510kreport.com/methodology