510(k) Report

510(k) · Cleared

Cleared

SYNFIX Evolution Secured Spacer System

K150673510(k) TraditionalCleared Aug 21, 2015158-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 · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

Cleared on Aug 21, 2015 as substantially equivalent to K072253 (Synthes Spine Co.Lp, 2007) and 5 other predicates after a 158-day review. Its family tree reaches back 16 generations to 1984. 137 later devices descend from it.

Decided
Aug 21, 2015
Review
158 days
Class
Class II
Product code
OVD
Recalls
None
Predicates
6

Its longest line of descent runs back 16 generations to K841189 (1984). 143 ancestors in all. 137 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 2 other ancestors2013: 3 other ancestors2012: 3 other ancestors2008: 20 other ancestors2007: 8 other ancestors2011: 6 other ancestors2010: 7 other ancestors2009: 9 other ancestors2002: 8 other ancestors2001: 10 other ancestors1996: 2 other ancestors2005: 13 other ancestors2004: 17 other ancestors2003: 13 other ancestors1999: 2 other ancestors2000: 1 other ancestor2006: 3 other ancestors2018: 3 descendants cleared2016: 1 descendant cleared2025: 26 descendants cleared2020: 6 descendants cleared2023: 15 descendants cleared2022: 15 descendants cleared2017: 1 descendant cleared2019: 6 descendants 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 · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007×3: 3 generations cleared close together, K080083 (2008), K073109 (2008), K081849 (2008) K091301 · Life Spine Stand-Alone Spacer System · Life Spine · 2009K100802 · Aesculap Implant Systems Sibd Spinal System · Aesculap Implant Systems, Inc. · 2010K111122 · Aesculap Sibd XP Spinal System · Aesculap Implant Systems, Inc. · 2011K141942 · Midline II TI · Centinel Spine, Inc. · 201419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 22 other ancestors3 generations back: 31 other ancestors4 generations back: 23 other ancestors5 generations back: 23 other ancestors6 generations back: 14 other ancestors7 generations back: 6 other ancestors8 generations back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 8 descendants3 generations forward: 10 descendants4 generations forward: 22 descendants5 generations forward: 37 descendants6 generations forward: 33 descendants7 generations forward: 19 descendants8 generations forward: 3 descendants K141942 · Midline II TI · Centinel Spine, Inc. · 2014K111122 · Aesculap Sibd XP Spinal System · Aesculap Implant Systems, Inc. · 2011K100802 · Aesculap Implant Systems Sibd Spinal System · Aesculap Implant Systems, Inc. · 2010K091301 · Life Spine Stand-Alone Spacer System · Life Spine · 2009K081849 · Blackstone Pillar SA Partial Vertebral Body Replacement Device · Blackstone Medical, Inc. · 2008 · recalledK073109 · Stalif TT Intervertebral Body Fusion System · Surgicraft, Ltd. · 2008K080083 · Intrepid Spinal System · Medtronic Sofamor Danek · 2008 · recalledK072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 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. · 1984−15−10−50+5
  1. Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 12 generations between
  3. 3 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
  4. 2 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
  5. 1 generation backK141942 Midline II TICentinel Spine, Inc. · 2014
  6. This deviceK150673 SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC · 2015
  7. Descendant · cites it directly · 127 of its ownK162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution…Synthes USA Products, LLC · 2016
  8. 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
  9. 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
  10. Descendant · 4 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
  11. Descendant · 5 generations on · 81 of its ownK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
Show all 16 generations
  1. Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 9 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 7 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
  11. 6 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
  12. 5 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
  13. 4 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
  14. 3 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
  15. 2 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
  16. 1 generation backK141942 Midline II TICentinel Spine, Inc. · 2014
  17. This deviceK150673 SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC · 2015

Showing 5 of 137 descendants. See all descendants

Descendants cleared per year

2016: 12017: 12018: 32019: 62020: 62021: 82022: 152023: 152024: 282025: 262026: 28
2016high 28 (2024) · low 1 (2016)2026

Most influential descendants

Showing 5 of 137 · 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
−16K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−15K990148Stackable Cage SystemDepuy Motech Acromed1999—
−14K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−13K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−12K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−11K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−10K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−9K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−8K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−7K080083Intrepid Spinal SystemMedtronic Sofamor Danek20088
−6K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008—
−5K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20081
−4K091301Life Spine Stand-Alone Spacer SystemLife Spine2009—
−3K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010—
−2K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011—
−1K141942Midline II TICentinel Spine, Inc.2014—
0 (this device)K150673SYNFIX Evolution Secured Spacer SystemSynthes (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—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
2001100
200280
2003130
2004170
2005130
200630
200780
2008200
200990
201070
201160
201230
201330
201420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201710
201830
201960
202060
202180
2022150
2023150
2024280
2025260
2026280
FIG. 1 — Lineage of K150673, 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 OVD? 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 OVD device

  1. #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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
*K072253Synfix-LR Spacer
Summary page 4
…Device Regulation Number: 21 CFR 888.3080 Classification Panel: Orthopaedic and Rehabilitation Devices Panel (87) Primary Predicate: Synthes SYNFIX-LR (K072253) Additional Predicates: Synthes Zero-P (K072981) Synthes SYNCAGE Evolution (K122639)…
Synthes Spine Co.Lp20071
*K072981Synthes Zero-P
Summary page 4
…lassification Panel: Orthopaedic and Rehabilitation Devices Panel (87) Primary Predicate: Synthes SYNFIX-LR (K072253) Additional Predicates: Synthes Zero-P (K072981) Synthes SYNCAGE Evolution (K122639) Synthes SYNFIX Lateral (K131276)…
Synthes Spine Co.Lp20082
*K122639Synthes Syncage Evolution Spacer
Summary page 4
…s Panel (87) Primary Predicate: Synthes SYNFIX-LR (K072253) Additional Predicates: Synthes Zero-P (K072981) Synthes SYNCAGE Evolution (K122639) Synthes SYNFIX Lateral (K131276) Medtronic Sovereign (K121982)…
Synthes (USA) Products, LLC2013—
*K131276Lateral Synfix
Summary page 4
…K072253) Additional Predicates: Synthes Zero-P (K072981) Synthes SYNCAGE Evolution (K122639) Synthes SYNFIX Lateral (K131276) Medtronic Sovereign (K121982) Centinel Spine Midline II (K141942) Device Desc…
Synthes (USA) Products, LLC2014—
*K121982Sovereign Spinal System
Summary page 4
…981) Synthes SYNCAGE Evolution (K122639) Synthes SYNFIX Lateral (K131276) Medtronic Sovereign (K121982) Centinel Spine Midline II (K141942) Device Description: The SYNFIX Evolution Secured Spacer Syste…
Medtronic Sofamor Danek2012—
*K141942Midline II TI
Summary page 4
…639) Synthes SYNFIX Lateral (K131276) Medtronic Sovereign (K121982) Centinel Spine Midline II (K141942) Device Description: The SYNFIX Evolution Secured Spacer System is a combination radiolucent and r…
Centinel Spine, Inc.2014—

Also cleared against K072253: 27 other devices →

What descends from it? (137)

See all 137

5 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
K201585Monterey AL Interbody SystemStryker Corporation20204
K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182
K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251
K180695FBC 921 (Alif)Fbc Device Aps20180

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 31 years and passes through 14 companies; a new generation was cleared every 1.0 years on median.
  • 19 of the 143 ancestors have a recall of any class.
  • Of its descendants, K162358 (Synthes USA Products, LLC, 2016) has gone furthest, with 127 descendants of its own.
  • 27 other devices also cite its predicate K072253.

How does its category compare?

All OVD devices

OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · OVD

10in 2025

2007: 22008: 82009: 32010: 82011: 92012: 102013: 112014: 142015: 122016: 132017: 122018: 142019: 122020: 142021: 72022: 142023: 122024: 122025: 102026 (partial year): 8
2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVD

100in 2025

2008: 84 days median2009: 152 days median2010: 117 days median2011: 167 days median2012: 78 days median2013: 137 days median2014: 139 days median2015: 166 days median2016: 127 days median2017: 127 days median2018: 126 days median2019: 91 days median2020: 91 days median2021: 108 days median2022: 133 days median2023: 92 days median2024: 110 days median2025: 100 days median2026 (partial year): 93 days median
2007high 167 (2011) · low 78 (2012)2026

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

Recalls per year · OVD

1in 2025

2013: 42016: 12021: 12022: 12025: 12026 (partial year): 1
2007high 4 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OVD

50in 2025

2009: 22010: 22011: 62012: 162013: 172014: 352015: 432016: 552017: 722018: 1122019: 1712020: 2032021: 2212022: 742023: 672024: 922025: 50
2007high 221 (2021) · low 0 (2007)2025

MAUDE reports naming product code OVD, 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
20072—00
200888400
2009315202
2010811702
2011916706
20121078016
201311137417
201414139035
201512166043
201613127155
201712127072
2018141260112
201912910171
202014910203
202171081221
202214133174
20231292067
202412110092
202510100150
20268931—

What is it indicated for?

The SYNFIX Evolution Secured Spacer System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SYNFIX Evolution can be packed with 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 K072253

27 other devices cite the same predicate.

  • K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine · 2025
  • K180963Roccia Alif, Roccia TlifSilony Medical GmbH · 2018
  • K170676HD Lumbar Interbody SystemHd Lifesciences, LLC · 2017
  • K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc. · 2017
  • K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc. · 2016
  • K142271Zavation Z-Link LumbarZavation, LLC · 2014

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 OVD

The OVD category page

  • K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium…INNO Holdings Inc. DBA Innovasis · 2026
  • K261408SABER-XA SystemElevation Spine · 2026
  • K261809Interwedge® Standalone LateralFoundation Surgical Group · 2026
  • K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc. · 2026
  • K260810Anteralign LS coverplateTyber Medical, LLC · 2026

https://510kreport.com/device/K150673 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150673: SYNFIX Evolution Secured 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/K150673

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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