510(k) Report

510(k) · Cleared

Cleared

Synthes Syncage Evolution Spacer

K122639510(k) TraditionalCleared May 24, 2013268-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 May 24, 2013 as substantially equivalent to K072791 (Synthes Spine, 2007) and 4 other predicates after a 268-day review. Its family tree reaches back 9 generations to 1984. 143 later devices descend from it.

Decided
May 24, 2013
Review
268 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
6

Its longest line of descent runs back 9 generations to K841189 (1984). 29 ancestors in all. 143 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2008: 5 other ancestors2007: 3 other ancestors2004: 1 other ancestor2003: 1 other ancestor2001: 3 other ancestors1999: 1 other ancestor1996: 2 other ancestors2002: 2 other ancestors2000: 1 other ancestor2018: 5 descendants cleared2015: 2 descendants cleared2020: 7 descendants cleared2016: 1 descendant cleared2025: 26 descendants cleared2017: 2 descendants cleared2024: 28 descendants cleared2022: 15 descendants cleared2023: 15 descendants cleared2019: 6 descendants cleared2026: 28 descendants cleared2021: 8 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. · 2005K081917 · Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems · Depuy Spine, Inc. · 200919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 9 other ancestors3 generations back: 4 other ancestors4 generations back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 8 descendants3 generations forward: 9 descendants4 generations forward: 11 descendants5 generations forward: 19 descendants6 generations forward: 36 descendants7 generations forward: 33 descendants8 generations forward: 19 descendants9 generations forward: 3 descendants K081917 · Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems · 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. · 1984−50+5
  1. Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 5 generations between
  3. 3 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
  4. 2 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
  5. 1 generation backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
  6. This deviceK122639 Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC · 2013
  7. Descendant · cites it directly · 137 of its ownK150673 SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC · 2015
  8. Descendant · 2 generations on · 127 of its ownK162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution…Synthes USA Products, LLC · 2016
  9. Descendant · 3 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
  10. Descendant · 4 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
  11. Descendant · 5 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
Show all 9 generations
  1. Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 6 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
  5. 5 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
  6. 4 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
  7. 3 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
  8. 2 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
  9. 1 generation backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
  10. This deviceK122639 Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC · 2013

Showing 5 of 143 descendants. See all descendants

Descendants cleared per year

2015: 22016: 12017: 22018: 52019: 62020: 72021: 82022: 152023: 152024: 282025: 262026: 28
2015high 28 (2024) · low 1 (2016)2026

Most influential descendants

Showing 5 of 143 · See all
  • K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC · 2015 · cites it directly137descendants
  • K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC · 2016 · 2 generations on127descendants
  • K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2017 · 3 generations on109descendants
  • K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2019 · 4 generations on108descendants
  • K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc. · 2019 · 5 generations on102descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−8K990148Stackable Cage SystemDepuy Motech Acromed1999—
−7K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−6K020522Modification to Surgical Titanium Mesh SystemDepuyacromed2002—
−5K030833Depuy Acromed VBR SystemDepuyacromed2003—
−4K031635Depuy Acromed VBR SystemDepuyacromed2003—
−3K041722Modification to VBR Spinal SystemDepuy Spine, Inc.2004—
−2K052746Concorde VBR Spinal SystemDepuy Spine, Inc.2005—
−1K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc.2009—
0 (this device)K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013—
+1K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015—
+2K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal…Medtronic Sofamor Danek USA, Inc.2017—
+4K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal…Medtronic Sofamor Danek USA, Inc.2019—
+5K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc.20194

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199910
200010
200130
200220
200310
200410
200730
200850
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201610
201720
201850
201960
202070
202180
2022150
2023150
2024280
2025260
2026280
FIG. 1 — Lineage of K122639, 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K072791Oracle Spacer, Opal Spacer
Summary page 1
…(87) Clasifcaton: Product Code MAX (Intervertebral Fusion Device with Bone Graft, Lumbar) Synthes OPAL Spacer (K07279 1) LDR Spine ROl-A (K090507) Predicates: Bi6met Enclave (K08 1636) SeaS…
Synthes Spine20071
*K090507Modification to LDR Spine Roi Interbody Fusion System; Roi-a Implant System
Summary page 1
…rvertebral Fusion Device with Bone Graft, Lumbar) Synthes OPAL Spacer (K07279 1) LDR Spine ROl-A (K090507) Predicates: Bi6met Enclave (K08 1636) SeaSpine Redondo (K0823 10) De…
Ldr Spine USA20091
*K081636Peek-Optima Alif Spacer
Summary page 1
…Lumbar) Synthes OPAL Spacer (K07279 1) LDR Spine ROl-A (K090507) Predicates: Bi6met Enclave (K08 1636) SeaSpine Redondo (K0823 10) DePuy Spine Cougar (K081917 & KI 113348)…
Biomet Spine2008—
*K082310Hollywood, Pacifica, Redondo, Ventura
Summary page 1
…thes OPAL Spacer (K07279 1) LDR Spine ROl-A (K090507) Predicates: Bi6met Enclave (K08 1636) SeaSpine Redondo (K0823 10) DePuy Spine Cougar (K081917 & KI 113348) The Synthes SynCage Evolution spacer is…
Seaspine, Inc.2008—
*K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems
Summary page 1
…R Spine ROl-A (K090507) Predicates: Bi6met Enclave (K08 1636) SeaSpine Redondo (K0823 10) DePuy Spine Cougar (K081917 & KI 113348) The Synthes SynCage Evolution spacer is a radiolucent device for use in…
Depuy Spine, Inc.2009—
Kept off the family treeK111348FDA’s K111348 is RE / Stasis (TM) Gingival Retraction Paste
Our reading of the summary gave K111348, FDA’s number for RE / Stasis (TM) Gingival Retraction Paste (Centrix, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “DePuy Spine Cougar”. Kept off the family tree.
Centrix, Inc.2011—

Also cleared against K072791: 28 other devices →

What descends from it? (143)

See all 143

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

NumberDeviceApplicantDecidedDescendants
K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137
K181702Tranquil-L Interbody SystemNexus Spine, LLC20188
K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151
K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200
K181899Roccia® PlifSilony Medical GmbH20180

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 5 companies; a new generation was cleared every 1.3 years on median.
  • 4 of the 29 ancestors have a recall of any class.
  • Of its descendants, K150673 (Synthes (USA) Products, LLC, 2015) has gone furthest, with 137 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 SynCage Evolution 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 SynCage Evolution 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 non-operative treatment.

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/K122639 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122639: Synthes Syncage Evolution Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122639

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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