510(k) Report

510(k) · Cleared

Cleared

Falcon Spacer

K123180510(k) TraditionalCleared Jan 8, 201390-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 Jan 8, 2013 as substantially equivalent to K072791 (Synthes Spine, 2007) and 1 other predicate after a 90-day review. Its family tree reaches back 11 generations to 1984. 147 later devices descend from it.

Decided
Jan 8, 2013
Review
90 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
2

Its longest line of descent runs back 11 generations to K841189 (1984). 21 ancestors in all. 147 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 3 other ancestors2008: 2 other ancestors1999: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor2003: 1 other ancestor2014: 2 descendants cleared2018: 5 descendants cleared2019: 7 descendants cleared2015: 1 descendant cleared2023: 15 descendants cleared2016: 1 descendant cleared2025: 26 descendants cleared2020: 9 descendants cleared2022: 16 descendants cleared2017: 1 descendant cleared2026: 28 descendants cleared2021: 8 descendants cleared2024: 28 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K020522 · Modification to Surgical Titanium Mesh System · Depuyacromed · 2002×2: 2 generations cleared close together, K030833 (2003), K031635 (2003) K041722 · Modification to VBR Spinal System · Depuy Spine, Inc. · 2004K052746 · Concorde VBR Spinal System · Depuy Spine, Inc. · 2005K090899 · Depuy Spine Lateral System · Depuy Spine, Inc. · 2009K093242 · Patriot Transcontinental Llif Spacer · Globus Medical, Inc. · 2009K102313 · Patriot Transcontinental M Spacers · Globus Medical, Inc. · 201019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 1 other ancestor4 generations back: 4 other ancestors5 generations back: 1 other ancestor6 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 9 descendants4 generations forward: 9 descendants5 generations forward: 10 descendants6 generations forward: 22 descendants7 generations forward: 37 descendants8 generations forward: 33 descendants9 generations forward: 19 descendants10 generations forward: 3 descendants K102313 · Patriot Transcontinental M Spacers · Globus Medical, Inc. · 2010K093242 · Patriot Transcontinental Llif Spacer · Globus Medical, Inc. · 2009K090899 · Depuy Spine Lateral System · Depuy Spine, Inc. · 2009K052746 · Concorde VBR Spinal System · Depuy Spine, Inc. · 2005K041722 · Modification to VBR Spinal System · Depuy Spine, Inc. · 2004K031635 · Depuy Acromed VBR System · Depuyacromed · 2003K030833 · Depuy Acromed VBR System · Depuyacromed · 2003K020522 · Modification to Surgical Titanium Mesh System · Depuyacromed · 2002K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50+5+10
  1. Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 7 generations between
  3. 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
  4. 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
  5. 1 generation backK102313 Patriot Transcontinental M SpacersGlobus Medical, Inc. · 2010
  6. This deviceK123180 Falcon SpacerSynthes (USA) Products, LLC · 2013
  7. Descendant · cites it directly · 146 of its ownK131276 Lateral SynfixSynthes (USA) Products, LLC · 2014
  8. Descendant · 2 generations on · 137 of its ownK150673 SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC · 2015
  9. Descendant · 3 generations on · 127 of its ownK162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution…Synthes USA Products, LLC · 2016
  10. Descendant · 4 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
  11. Descendant · 5 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
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 backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
  5. 7 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
  6. 6 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
  7. 5 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
  8. 4 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
  9. 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
  10. 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
  11. 1 generation backK102313 Patriot Transcontinental M SpacersGlobus Medical, Inc. · 2010
  12. This deviceK123180 Falcon SpacerSynthes (USA) Products, LLC · 2013

Showing 5 of 147 descendants. See all descendants

Descendants cleared per year

2014: 22015: 12016: 12017: 12018: 52019: 72020: 92021: 82022: 162023: 152024: 282025: 262026: 28
2014high 28 (2024) · low 1 (2015)2026

Most influential descendants

Showing 5 of 147 · See all
  • K131276Lateral SynfixSynthes (USA) Products, LLC · 2014 · cites it directly146descendants
  • K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC · 2015 · 2 generations on137descendants
  • K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC · 2016 · 3 generations on127descendants
  • K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2017 · 4 generations on109descendants
  • K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2019 · 5 generations on108descendants
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—
−8K020522Modification to Surgical Titanium Mesh SystemDepuyacromed2002—
−7K030833Depuy Acromed VBR SystemDepuyacromed2003—
−6K031635Depuy Acromed VBR SystemDepuyacromed2003—
−5K041722Modification to VBR Spinal SystemDepuy Spine, Inc.2004—
−4K052746Concorde VBR Spinal SystemDepuy Spine, Inc.2005—
−3K090899Depuy Spine Lateral SystemDepuy Spine, Inc.2009—
−2K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc.2009—
−1K102313Patriot Transcontinental M SpacersGlobus Medical, Inc.2010—
0 (this device)K123180Falcon SpacerSynthes (USA) Products, LLC2013—
+1K131276Lateral SynfixSynthes (USA) Products, LLC2014—
+2K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015—
+3K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal…Medtronic Sofamor Danek USA, Inc.2017—
+5K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal…Medtronic Sofamor Danek USA, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200120
200310
200730
200820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201510
201610
201710
201850
201970
202090
202180
2022160
2023150
2024280
2025260
2026280
FIG. 1 — Lineage of K123180, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K072791Oracle Spacer, Opal Spacer
Summary page 1
…Orthopaedic and Rehabilitation Devices Panel ____________Product Code MAX Class 11 Synthes Oracle Spacer (K072791) Predicates: Synthes OPAL Spacer (K07279 1) Globus Medical PATRIOT TransContinental Spa…
Synthes Spine20071
*K102313Patriot Transcontinental M Spacers
Summary page 1
…Synthes Oracle Spacer (K072791) Predicates: Synthes OPAL Spacer (K07279 1) Globus Medical PATRIOT TransContinental Spacer (K 102313) The Falcon Spacer is a radiolucent, oval-shaped spacer intended to be used…
Globus Medical, Inc.2010—

Also cleared against K072791: 28 other devices →

What descends from it? (147)

See all 147

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131276Lateral SynfixSynthes (USA) Products, LLC2014146

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 29 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
  • 1 of the 21 ancestors has a recall of any class.
  • Of its descendants, K131276 (Synthes (USA) Products, LLC, 2014) has gone furthest, with 146 descendants of its own.
  • 28 other devices also cite its predicate K072791.

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. 2013, 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 Falcon Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to SI whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Falcon Spacer should be packed with autogenotis 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 Falcon Spacer is intended to be used with supplemental fixation.

Indications for use as stated in the FDA summary.

Also cleared against K072791

28 other devices cite the same predicate.

  • K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd. · 2024
  • K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited · 2022
  • K211845Deploy Expandable Interbody SystemSouthern Spine, LLC · 2021
  • K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
  • K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC · 2018
  • K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc. · 2017

More from Synthes (USA) Products, LLC

45 FDA decisions under this applicant name. See the company

  • K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC · 2026
  • K212943SyntheCel Dura RepairSynthes (USA) Products, LLC · 2022
  • K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC · 2021
  • K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC · 2021
  • K210205DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating SystemSynthes (USA) Products, LLC · 2021

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/K123180 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123180: Falcon Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123180

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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