510(k) Report

510(k) · Cleared

Cleared

Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)

K070218510(k) TraditionalCleared Apr 6, 200773-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vertiflex (Tm), Incorporated · MQP Spinal Vertebral Body Replacement Device

Cleared on Apr 6, 2007 as substantially equivalent to K050861 (Interpore Cross Intl., 2005) and 4 other predicates after a 73-day review. Its family tree reaches back 9 generations to 2001. 60 later devices descend from it.

Decided
Apr 6, 2007
Review
73 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
5

Its longest line of descent runs back 9 generations to K003155 (2001). 29 ancestors in all, the oldest K841189 (1984). 60 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2005: 1 other ancestor2004: 5 other ancestors2002: 2 other ancestors2003: 3 other ancestors2001: 5 other ancestors2000: 1 other ancestor1999: 1 other ancestor1984: 1 other ancestor2011: 1 descendant cleared2008: 1 descendant cleared2014: 2 descendants cleared2013: 2 descendants cleared2019: 1 descendant cleared2015: 2 descendants cleared2017: 1 descendant cleared2016: 1 descendant cleared2018: 3 descendants cleared2021: 2 descendants cleared2020: 4 descendants cleared2024: 8 descendants cleared2023: 9 descendants cleared2025: 9 descendants cleared2026: 10 descendants cleared2022: 4 descendants clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×2: 2 generations cleared close together, K021791 (2002), K023570 (2002) K031780 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004×2: 2 generations cleared close together, K042571 (2005), K050624 (2005) K062132 · Avs PL Peek Spacer System · Stryker Spine · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors3 generations back: 3 other ancestors4 generations back: 5 other ancestors5 generations back: 3 other ancestors6 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 6 descendants4 generations forward: 7 descendants5 generations forward: 11 descendants6 generations forward: 11 descendants7 generations forward: 12 descendants8 generations forward: 2 descendants9 generations forward: 3 descendants10 generations forward: 1 descendant K062132 · Avs PL Peek Spacer System · Stryker Spine · 2006K050624 · Stryker Spine Avs PL Peek Spacer · Stryker Spine · 2005K042571 · Stryker Spine Avs TL Peek Spacer · Stryker Spine · 2005K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004K031780 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−50+5+10
  1. Root · 9 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 5 generations between
  3. 3 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
  4. 2 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  5. 1 generation backK062132 Avs PL Peek Spacer SystemStryker Spine · 2006
  6. This deviceK070218 Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated · 2007
  7. Descendant · cites it directly · 55 of its ownK082270 Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc. · 2008
  8. Descendant · 2 generations on · 47 of its ownK132582 Exactech Acapella One Cervical Spacer SystemExactech, Inc. · 2014 · Recalled
  9. Descendant · 3 generations on · 39 of its ownK171489 Acapella Cervical Spacer SystemChoicespine, LP · 2017
  10. Descendant · 4 generations on · 25 of its ownK200087 F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC · 2020
  11. Descendant · 3 generations on · 19 of its ownK152099 Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine · 2016
Show all 9 generations
  1. Root · 9 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 8 generations backK012254 VBROsteotech, Inc. · 2001
  3. 7 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 6 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 5 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 4 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
  7. 3 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
  8. 2 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  9. 1 generation backK062132 Avs PL Peek Spacer SystemStryker Spine · 2006
  10. This deviceK070218 Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated · 2007

Showing 5 of 60 descendants. See all descendants

Descendants cleared per year

2008: 12011: 12013: 22014: 22015: 22016: 12017: 12018: 32019: 12020: 42021: 22022: 42023: 92024: 82025: 92026: 10
2008high 10 (2026) · low 0 (2009)2026

Most influential descendants

Showing 5 of 60 · See all
  • K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc. · 2008 · cites it directly55descendants
  • K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc. · 2014 · 2 generations on47descendants
  • K171489Acapella Cervical Spacer SystemChoicespine, LP · 2017 · 3 generations on39descendants
  • K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC · 2020 · 4 generations on25descendants
  • K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine · 2016 · 3 generations on19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−8K012254VBROsteotech, Inc.2001—
−7K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−6K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−5K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−4K040731Stryker Spine Vertebral SpacerStryker Spine2004—
−3K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005—
−2K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005—
−1K062132Avs PL Peek Spacer SystemStryker Spine2006—
0 (this device)K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated2007—
+1K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.2008—
+2K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.20141
+3K171489Acapella Cervical Spacer SystemChoicespine, LP2017—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC2020—
+3K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199910
200010
200150
200220
200330
200450
200510
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201110
201320
201420
201520
201610
201710
201830
201910
202040
202120
202240
202390
202480
202590
2026100
FIG. 1 — Lineage of K070218, 2001–2026Source: 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 MQP? 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 MQP device

  1. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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? (5)

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
*K050861Peek Cas
Summary page 1
…device is substantially equivalent, in whole or in part, to the following commercially available predicate devices: Interpore Cross PEEK CAS (K050861) Quantum Orthopedics CrystalTM and LucentTM (K062004) Signus Medizintechnik Curved TetrisTM (…
Interpore Cross Intl.2005—
*K062004Modification to Quantum Vertebral Body Replacement
Summary page 1
…ing commercially available predicate devices: Interpore Cross PEEK CAS (K050861) Quantum Orthopedics CrystalTM and LucentTM (K062004) Signus Medizintechnik Curved TetrisTM (K041888) Stryker Spine A VSTM PL Spacer (K062132)…
Quantum Orthopedics, Inc.2006—
*K041888Curved Peek Tetris Spinal Implant
Summary page 1
…Interpore Cross PEEK CAS (K050861) Quantum Orthopedics CrystalTM and LucentTM (K062004) Signus Medizintechnik Curved TetrisTM (K041888) Stryker Spine A VSTM PL Spacer (K062132) Synthes Vertebral Spacer (K011037) 5.4 Device…
Signus Medizintechnik GmbH2004—
*K062132Avs PL Peek Spacer System
Summary page 1
…Quantum Orthopedics CrystalTM and LucentTM (K062004) Signus Medizintechnik Curved TetrisTM (K041888) Stryker Spine A VSTM PL Spacer (K062132) Synthes Vertebral Spacer (K011037) 5.4 Device Description The VertiFlexTM OctaneTM PEEK Vertebra…
Stryker Spine2006—
*K011037Vertebral Spacer
Summary page 1
…Signus Medizintechnik Curved TetrisTM (K041888) Stryker Spine A VSTM PL Spacer (K062132) Synthes Vertebral Spacer (K011037) 5.4 Device Description The VertiFlexTM OctaneTM PEEK Vertebral Body Replacement, or PEEK VBR, is an impla…
Synthes (Usa)2002—

Also cleared against K050861: 2 other devices →

What descends from it? (60)

See all 60

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

NumberDeviceApplicantDecidedDescendants
K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855
K102315Staxx XDL SystemSpine Wave, Inc.20113

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 6 years and passes through 4 companies; a new generation was cleared every 8 months on median.
  • 2 of the 29 ancestors have a recall of any class.
  • Of its descendants, K082270 (Vertiflex, Inc., 2008) has gone furthest, with 55 descendants of its own.
  • 2 other devices also cite its predicate K050861.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MQP

4in 2024

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

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

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
2007high 15 (2020) · low 0 (2008)2026

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

Adverse event reports per year · MQP

168in 2025

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, 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
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

What is it indicated for?

The VertiFlex TM PEEK VBR is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The VertiFlex TM PEEK VBR is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period. The interior of the VertiFlexTM PEEK VBR may be packed with bone graft.

Indications for use as stated in the FDA summary.

Also cleared against K050861

2 other devices cite the same predicate.

  • K112014Zyston Straight Spacer SystemBiomet Spine · 2011
  • K091381Ibex Spinal SystemEbi, L.P. · 2009

More from Vertiflex (Tm), Incorporated

2 FDA decisions under this applicant name. See the company

  • K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated · 2007

Recent decisions in MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K070218 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070218: Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070218

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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