510(k) Report

510(k) · Cleared

Cleared

DePuy Synthes T-PAL Ti Spacer

K151276510(k) SpecialCleared Jun 18, 201536-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

Synthes USA Products, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Jun 18, 2015 as substantially equivalent to K100089 (Synthes Spine, 2010) after a 36-day review. Its family tree reaches back 1 generation to 2010. 129 later devices descend from it.

Decided
Jun 18, 2015
Review
36 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K100089 (2010). 129 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2018: 2 descendants cleared2023: 14 descendants cleared2022: 15 descendants cleared2017: 1 descendant cleared2020: 5 descendants cleared2019: 4 descendants cleared2021: 8 descendants cleared2026: 26 descendants cleared2025: 25 descendants cleared2024: 28 descendants clearedReference device: K122097 · Patriot Spacers · Globus Medical, Inc. · 2012K100089 · Synthes T-Pal Spacer · Synthes Spine · 2010 · recalled2010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 8 descendants4 generations forward: 22 descendants5 generations forward: 37 descendants6 generations forward: 33 descendants7 generations forward: 19 descendants8 generations forward: 3 descendants K100089 · Synthes T-Pal Spacer · Synthes Spine · 2010 · recalled0+5
  1. Root · 1 generation backK100089 Synthes T-Pal SpacerSynthes Spine · 2010 · Recalled
  2. This deviceK151276 DePuy Synthes T-PAL Ti SpacerSynthes USA Products, LLC · 2015
  3. Descendant · cites it directly · 127 of its ownK162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution…Synthes USA Products, LLC · 2016
  4. Descendant · 2 generations on · 109 of its ownK171689 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2017
  5. Descendant · 3 generations on · 108 of its ownK190959 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2019
  6. Descendant · 4 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
  7. Descendant · 5 generations on · 81 of its ownK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020

Showing 5 of 129 descendants. See all descendants

Descendants cleared per year

2016: 12017: 12018: 22019: 42020: 52021: 82022: 152023: 142024: 282025: 252026: 26
2016high 28 (2024) · low 1 (2016)2026

Most influential descendants

Showing 5 of 129 · See all
  • K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC · 2016 · cites it directly127descendants
  • K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2017 · 2 generations on109descendants
  • K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2019 · 3 generations on108descendants
  • K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc. · 2019 · 4 generations on102descendants
  • K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc. · 2020 · 5 generations on81descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K100089Synthes T-Pal SpacerSynthes Spine20101
0 (this device)K151276DePuy Synthes T-PAL Ti SpacerSynthes USA Products, LLC2015—
+1K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016—
+2K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal…Medtronic Sofamor Danek USA, Inc.2017—
+3K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal…Medtronic Sofamor Danek USA, Inc.2019—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc.20194
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic…Titan Spine, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201710
201820
201940
202050
202180
2022150
2023140
2024280
2025250
2026260
FIG. 1 — Lineage of K151276, 2010–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K100089Synthes T-Pal Spacer
Summary page 4
…usion Device with Bone Graft, Lumbar Intervertebral Body Fusion Device per 21 CFR §888.3080 Product Code MAX (Intervertebral body fusion device) Synthes T-PAL Spacer (K100089) Patriot Signature® Ti Spacer (K122097) K151276 Page 2 of 3 The DePuy Synthes T-PAL Ti Spacer is an interbody f…
Synthes Spine20101
†K122097Patriot SpacersGlobus Medical, Inc.2012—

Also cleared against K100089: 17 other devices →

What descends from it? (129)

See all 129

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127
K181231DePuy Synthes T-PAL Spacer SystemDepuy Synthes Spine20180

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?

  • Its one ancestor has a recall.
  • Of its descendants, K162358 (Synthes USA Products, LLC, 2016) has gone furthest, with 127 descendants of its own.
  • 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. 2015, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

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

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
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

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K100089

17 other devices cite the same predicate.

  • K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd. · 2026
  • K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd. · 2024
  • K191353COMET Lumbar Interbody Fusion CageBaui Biotech Co., Ltd. · 2020
  • K181231DePuy Synthes T-PAL Spacer SystemDepuy Synthes Spine · 2018
  • K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC · 2018
  • K172828Double Medical Cage SystemDouble Medical Technology, Inc. · 2018

More from Synthes USA Products, LLC

16 FDA decisions under this applicant name. See the company

  • K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC · 2018
  • K170818Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC · 2017
  • K162594Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC · 2017
  • K170654USS SystemSynthes USA Products, LLC · 2017
  • K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm…Synthes USA Products, LLC · 2017

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K151276 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151276: DePuy Synthes T-PAL Ti Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151276

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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