510(k) Report

510(k) · Cleared

Cleared

Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R - Lordotic

K130434510(k) TraditionalCleared May 1, 201369-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

Exactech, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on May 1, 2013 as substantially equivalent to K082270 (Vertiflex, Inc., 2008) after a 69-day review. Its family tree reaches back 11 generations to 2001. 11 later devices descend from it.

Decided
May 1, 2013
Review
69 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
1

Its longest line of descent runs back 11 generations to K003155 (2001). 31 ancestors in all, the oldest K841189 (1984). 11 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 ancestor2015: 1 descendant cleared2019: 1 descendant cleared2020: 2 descendants cleared2021: 1 descendant cleared2026: 2 descendants cleared2024: 2 descendants cleared2023: 1 descendant cleared2025: 1 descendant 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 · 2006K070218 · Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR) · Vertiflex (Tm), Incorporated · 2007K082270 · Octane Vertebral Body Replacement (VBR) System · Vertiflex, Inc. · 200819801990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 4 other ancestors4 generations back: 3 other ancestors5 generations back: 3 other ancestors6 generations back: 5 other ancestors7 generations back: 3 other ancestors8 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants K082270 · Octane Vertebral Body Replacement (VBR) System · Vertiflex, Inc. · 2008K070218 · Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR) · Vertiflex (Tm), Incorporated · 2007K062132 · 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. · 2001−10−50
  1. Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 7 generations between
  3. 3 generations backK062132 Avs PL Peek Spacer SystemStryker Spine · 2006
  4. 2 generations backK070218 Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated · 2007
  5. 1 generation backK082270 Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc. · 2008
  6. This deviceK130434 Octane Straight, Octane Straight - Lordotic, Octane Straight I/R…Exactech, Inc. · 2013
  7. Descendant · cites it directly · 10 of its ownK150152 The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc. · 2015
  8. Descendant · cites it directly · 4 of its ownK191621 ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical…Choice Spine, LLC · 2019
  9. Descendant · 2 generations on · 3 of its ownK203311 ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC · 2021
  10. Descendant · 3 generations on · 2 of its ownK223869 ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC · 2023
  11. Descendant · 2 generations on · 2 of its ownK201367 FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc. · 2020
Show all 11 generations
  1. Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 10 generations backK012254 VBROsteotech, Inc. · 2001
  3. 9 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 8 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 7 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 6 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
  7. 5 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
  8. 4 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  9. 3 generations backK062132 Avs PL Peek Spacer SystemStryker Spine · 2006
  10. 2 generations backK070218 Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated · 2007
  11. 1 generation backK082270 Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc. · 2008
  12. This deviceK130434 Octane Straight, Octane Straight - Lordotic, Octane Straight I/R…Exactech, Inc. · 2013

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2015: 12019: 12020: 22021: 12023: 12024: 22025: 12026: 2
2015high 2 (2020) · low 0 (2016)2026

Most influential descendants

Showing 5 of 11 · See all
  • K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc. · 2015 · cites it directly10descendants
  • K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC · 2019 · cites it directly4descendants
  • K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC · 2021 · 2 generations on3descendants
  • K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC · 2023 · 3 generations on2descendants
  • K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc. · 2020 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−10K012254VBROsteotech, Inc.2001—
−9K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−8K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−7K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−6K040731Stryker Spine Vertebral SpacerStryker Spine2004—
−5K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005—
−4K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005—
−3K062132Avs PL Peek Spacer SystemStryker Spine2006—
−2K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated2007—
−1K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.2008—
0 (this device)K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane…Exactech, Inc.2013—
+1K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.2015—
+1K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody…Choice Spine, LLC2019—
+2K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC2021—
+3K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC2023—
+2K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.2020—

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
201510
201910
202020
202110
202310
202420
202510
202620
FIG. 1 — Lineage of K130434, 2001–2026Source: 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? (1)

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
*K082270Octane Vertebral Body Replacement (VBR) System
Summary page 1
…FDA Classification: Class 11 Predicate Device: 510(k) Number Trade or Proprietary or Model Name Manufacturer *K082270 Octane® P Intervertebral Body Fusion Device Exactech…
Vertiflex, Inc.2008—

Also cleared against K082270: 2 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510
K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194

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 12 years and passes through 6 companies; a new generation was cleared every 9 months on median.
  • 2 of the 31 ancestors have a recall of any class.
  • Of its descendants, K150152 (Exactech, Inc., 2015) has gone furthest, with 10 descendants of its own.
  • 2 other devices also cite its predicate K082270.

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 Octane Straight Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S I in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confinmed by history and radiographic studies. Patients should be skeletally mature, and have had at least 6 months of non-operative treatment. The device is intended for use with autogenous graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.

Indications for use as stated in the FDA summary.

Also cleared against K082270

2 other devices cite the same predicate.

  • K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC…Choice Spine, LLC · 2019
  • K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc. · 20141 recall

More from Exactech, Inc.

207 FDA decisions under this applicant name. See the company

  • K260583Equinoxe® Shoulder SystemExactech, Inc. · 2026
  • K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc. · 2025
  • K243448Equinoxe® Shoulder SystemExactech, Inc. · 2025
  • K243275Equinoxe® Scapula Fracture SystemExactech, Inc. · 2025
  • K243839Alteon® HA Femoral StemsExactech, Inc. · 2025

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/K130434 · printed Nov 4, 2026

Cite this page

510(k) Report. “K130434: Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R - Lordotic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130434

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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