510(k) · Cleared

Cleared

DePuy Synthes T-PAL Spacer System

K181231510(k) TraditionalCleared Dec 6, 2018211-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Depuy Synthes Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Dec 6, 2018 as substantially equivalent to K100089 (Synthes Spine, 2010) and 1 other predicate after a 211-day review. Its family tree reaches back 2 generations to 2010.

Decided: Dec 6, 2018
Review: 211 days
Class: Class II
Product code: MAX
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K100089 (2010). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK100089 Synthes T-Pal SpacerSynthes Spine · 2010 · Recalled
1 generation backK151276 DePuy Synthes T-PAL Ti SpacerSynthes USA Products, LLC · 2015
This deviceK181231 DePuy Synthes T-PAL Spacer SystemDepuy Synthes Spine · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K100089	Synthes T-Pal Spacer	Synthes Spine	2010	1
−1	K151276	DePuy Synthes T-PAL Ti Spacer	Synthes USA Products, LLC	2015	—
0 (this device)	K181231	DePuy Synthes T-PAL Spacer System	Depuy Synthes Spine	2018	—

FIG. 1 — Lineage of K181231, 2010–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MAX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MAX device

#1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K100089	Synthes T-Pal Spacer Summary page 4 …rvertebral Fusion, per 21 CFR 888.3080 Product Code: MAX Predicate Device Name Primary Predicate Trade Name: T-PAL Spacer System (K100089) Additional Predicate Device: DePuy Synthes T-PAL Ti Spacer System (K151276) D. Device Description The T-PAL Spa…	Synthes Spine	2010	1
*	K151276	DePuy Synthes T-PAL Ti Spacer Summary page 4 …Predicate Device Name Primary Predicate Trade Name: T-PAL Spacer System (K100089) Additional Predicate Device: DePuy Synthes T-PAL Ti Spacer System (K151276) D. Device Description The T-PAL Spacer System is an interbody fusion device used in conjunction with supplemental inte…	Synthes USA Products, LLC	2015	—

Also cleared against K100089: 17 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
1 of the 2 ancestors has a recall of any class.
17 other devices also cite its predicate K100089.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	86	0	12
2008	35	88	2	19
2009	31	102	9	90
2010	29	137	0	154
2011	49	98	3	201
2012	48	69	11 (1)	327
2013	58	102	0	380
2014	58	115	3	366
2015	53	113	1	524
2016	64	124	6	647
2017	76	116	1	596
2018	64	114	4	616
2019	60	131	1	699
2020	56	106	0	640
2021	53	109	0	622
2022	41	95	1	618
2023	30	87	0	576
2024	38	91	1	729
2025	29	85	5	811
2026	18	95	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K181231 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181231: DePuy Synthes T-PAL Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181231

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026