510(k) Report

510(k) · Cleared

Cleared

Depuy Pulse Lumbar Cage System

K120966510(k) TraditionalCleared Jul 3, 201295-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

Medos International SARL · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Jul 3, 2012 as substantially equivalent to K081917 (Depuy Spine, Inc., 2009) and 5 other predicates after a 95-day review. Its family tree reaches back 11 generations to 1984. 25 later devices descend from it.

Decided
Jul 3, 2012
Review
95 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
6

Its longest line of descent runs back 11 generations to K841189 (1984). 48 ancestors in all. 25 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 2 other ancestors2010: 1 other ancestor2009: 2 other ancestors1996: 2 other ancestors2008: 3 other ancestors2005: 2 other ancestors2004: 4 other ancestors2003: 4 other ancestors2002: 5 other ancestors2001: 9 other ancestors1999: 2 other ancestors2000: 1 other ancestor2018: 4 descendants cleared2020: 3 descendants cleared2022: 4 descendants cleared2019: 2 descendants cleared2021: 2 descendants cleared2023: 4 descendants cleared2025: 2 descendants cleared2024: 2 descendants cleared2026: 2 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 2004K043479 · MC+ Partial VBR · Ldr Spine USA · 2005K080728 · LDR Spine Roi-C Implant · Ldr Spine USA · 2008×2: 2 generations cleared close together, K083857 (2009), K091088 (2009) K103034 · Genesys Spine Interbody Fusion System · Genesys Spine · 2010 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 12 other ancestors3 generations back: 7 other ancestors4 generations back: 5 other ancestors5 generations back: 6 other ancestors6 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 9 descendants3 generations forward: 7 descendants4 generations forward: 6 descendants K103034 · Genesys Spine Interbody Fusion System · Genesys Spine · 2010 · recalledK091088 · LDR Spine Cervical Interbody Fusion System · Ldr Spine USA · 2009K083857 · LDR Spine Roi-C Implant · Ldr Spine USA · 2009K080728 · LDR Spine Roi-C Implant · Ldr Spine USA · 2008K043479 · MC+ Partial VBR · Ldr Spine USA · 2005K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50
  1. Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 7 generations between
  3. 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
  4. 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
  5. 1 generation backK103034 Genesys Spine Interbody Fusion SystemGenesys Spine · 2010 · Recalled
  6. This deviceK120966 Depuy Pulse Lumbar Cage SystemMedos International SARL · 2012
  7. Descendant · cites it directly · 15 of its ownK181397 DualXInnovasive, Inc. · 2018
  8. Descendant · 2 generations on · 5 of its ownK203038 Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2021
  9. Descendant · cites it directly · 5 of its ownK173082 Arco™-SA Lumbar Cage SystemNeurostructures, Inc. · 2018
  10. Descendant · 3 generations on · 4 of its ownK213355 Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2022
  11. Descendant · 2 generations on · 3 of its ownK222203 DualXSLIM (R) T/PLIFAmplify Surgical, Inc. · 2022
Show all 11 generations
  1. Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 6 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
  7. 5 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
  8. 4 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
  9. 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
  10. 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
  11. 1 generation backK103034 Genesys Spine Interbody Fusion SystemGenesys Spine · 2010 · Recalled
  12. This deviceK120966 Depuy Pulse Lumbar Cage SystemMedos International SARL · 2012

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2018: 42019: 22020: 32021: 22022: 42023: 42024: 22025: 22026: 2
2018high 4 (2018) · low 2 (2019)2026

Most influential descendants

Showing 5 of 25 · See all
  • K181397DualXInnovasive, Inc. · 2018 · cites it directly15descendants
  • K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2021 · 2 generations on5descendants
  • K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc. · 2018 · cites it directly5descendants
  • K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2022 · 3 generations on4descendants
  • K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc. · 2022 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−10K990148Stackable Cage SystemDepuy Motech Acromed1999—
−9K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−8K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−7K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−6K033109Ellys and Aurys Vertebral Body ReplacementsScient'X2004—
−5K043479MC+ Partial VBRLdr Spine USA2005—
−4K080728LDR Spine Roi-C ImplantLdr Spine USA2008—
−3K083857LDR Spine Roi-C ImplantLdr Spine USA2009—
−2K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009—
−1K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101
0 (this device)K120966Depuy Pulse Lumbar Cage SystemMedos International SARL2012—
+1K181397DualXInnovasive, Inc.2018—
+2K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.2021—
+1K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.2018—
+3K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.2022—
+2K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
200190
200250
200340
200440
200520
200830
200920
201010
201120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201840
201920
202030
202120
202240
202340
202420
202520
202620
FIG. 1 — Lineage of K120966, 1984–2026Source: 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? (6)

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
*K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc.2009—
*K103488Concorde Bullet Cage System
Summary page 1
…Graft, Lumbar Classification Name: Intervertebral Body Fusion Device Regulation Number: 888.3080 Predicate Devices: Concorde System - K081I91 7, K 103488 Concorde Curve System - K101923 Concorde Inline System - KI 110694…
Johnson and Johnson2011—
*K101923Concorde Curve System
Summary page 1
…y Fusion Device Regulation Number: 888.3080 Predicate Devices: Concorde System - K081I91 7, K 103488 Concorde Curve System - K101923 Concorde Inline System - KI 110694 Genesys Spine Interbody Fusion System -…
Depuy Spine2010—
*K110694Concorde Bullet Spinal System
Summary page 1
…Devices: Concorde System - K081I91 7, K 103488 Concorde Curve System - K101923 Concorde Inline System - KI 110694 Genesys Spine Interbody Fusion System - K 103034 RAY Threaded Fusion Cage -…
Johnson & Johnson2011—
*K103034Genesys Spine Interbody Fusion System
Summary page 1
…Concorde Curve System - K101923 Concorde Inline System - KI 110694 Genesys Spine Interbody Fusion System - K 103034 RAY Threaded Fusion Cage - P9500 19 Device Description: The lDePuy PULSE Lumbar Cage System is…
Genesys Spine20101
*P950019Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation
Summary page 1
…Concorde Inline System - KI 110694 Genesys Spine Interbody Fusion System - K 103034 RAY Threaded Fusion Cage - P9500 19 Device Description: The lDePuy PULSE Lumbar Cage System is designed for use as a lumbar interv…
Stryker Spine19961

Also cleared against K081917: 35 other devices →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K181397DualXInnovasive, Inc.201815
K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185
K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182

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 28 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
  • 7 of the 48 ancestors have a recall of any class.
  • Of its descendants, K181397 (Innovasive, Inc., 2018) has gone furthest, with 15 descendants of its own.
  • 35 other devices also cite its predicate K081917.

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. 2012, 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 PULSE Lumbar Cage System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via a PLIF or TLIF approach using autogenous bone. When used as intervertebral body fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.

Indications for use as stated in the FDA summary.

Also cleared against K081917

35 other devices cite the same predicate.

  • K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh…Medos International SARL · 2018
  • K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc. · 2018
  • K173148ACIFColigne AG · 2017
  • K170890TELIX K Interbody SystemBiedermann Motech GmbH & Co. KG · 2017
  • K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL · 2016
  • K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway · 2015

More from Medos International SARL

96 FDA decisions under this applicant name. See the company

  • K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL · 2026
  • K260240SYMPHONY Navigation Ready InstrumentsMedos International SARL · 2026
  • K253249TriALTIS™ Spine SystemMedos International SARL · 2025
  • K243249TriALTIS™ Spine SystemMedos International SARL · 2025
  • K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL · 2024

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/K120966 · printed Nov 5, 2026

Cite this page

510(k) Report. “K120966: Depuy Pulse Lumbar Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120966

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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