510(k) Report

510(k) · Cleared

Cleared

Maxim Surgical X-Treme Interbody Fusion System

K123206510(k) TraditionalCleared Feb 7, 2013118-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

Maxim Surgical · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Feb 7, 2013 as substantially equivalent to P980048 (Sulzer Spine-Tech, 2001) and 4 other predicates after a 118-day review. Its family tree reaches back 10 generations to 1984. 454 later devices descend from it.

Decided
Feb 7, 2013
Review
118 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
5

Its longest line of descent runs back 10 generations to K841189 (1984). 37 ancestors in all. 454 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2009: 1 other ancestor2001: 8 other ancestors2008: 3 other ancestors2005: 1 other ancestor2004: 3 other ancestors2002: 4 other ancestors1999: 2 other ancestors1996: 2 other ancestors2003: 1 other ancestor2000: 1 other ancestor2014: 4 descendants cleared2015: 2 descendants cleared2023: 66 descendants cleared2017: 18 descendants cleared2016: 4 descendants cleared2025: 61 descendants cleared2018: 19 descendants cleared2021: 38 descendants cleared2019: 32 descendants cleared2022: 52 descendants cleared2024: 56 descendants cleared2026: 55 descendants cleared2020: 47 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) K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 2004K043479 · MC+ Partial VBR · Ldr Spine USA · 2005K080728 · LDR Spine Roi-C Implant · Ldr Spine USA · 2008×2: 2 generations cleared close together, K083857 (2009), K091088 (2009) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 11 other ancestors3 generations back: 4 other ancestors4 generations back: 7 other ancestors5 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 18 descendants4 generations forward: 57 descendants5 generations forward: 117 descendants6 generations forward: 126 descendants7 generations forward: 72 descendants8 generations forward: 39 descendants9 generations forward: 16 descendants10 generations forward: 2 descendants11 generations forward: 1 descendant K091088 · LDR Spine Cervical Interbody Fusion System · Ldr Spine USA · 2009K083857 · LDR Spine Roi-C Implant · Ldr Spine USA · 2009K080728 · LDR Spine Roi-C Implant · Ldr Spine USA · 2008K043479 · MC+ Partial VBR · Ldr Spine USA · 2005K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 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. · 1984−10−50+5+10
  1. Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 6 generations between
  3. 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
  4. 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
  5. 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
  6. This deviceK123206 Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013
  7. Descendant · cites it directly · 453 of its ownK140003 Coroent Small Interbody SystemNuvasive, Inc. · 2014
  8. Descendant · 2 generations on · 449 of its ownK142050 Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated · 2014
  9. Descendant · 2 generations on · 444 of its ownK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
  10. Descendant · 2 generations on · 441 of its ownK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015
  11. Descendant · 3 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
Show all 10 generations
  1. Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 5 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
  7. 4 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
  8. 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
  9. 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
  10. 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
  11. This deviceK123206 Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013

Showing 5 of 454 descendants. See all descendants

Descendants cleared per year

2014: 42015: 22016: 42017: 182018: 192019: 322020: 472021: 382022: 522023: 662024: 562025: 612026: 55
2014high 66 (2023) · low 2 (2015)2026

Most influential descendants

Showing 5 of 454 · See all
  • K140003Coroent Small Interbody SystemNuvasive, Inc. · 2014 · cites it directly453descendants
  • K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated · 2014 · 2 generations on449descendants
  • K140921Coroent Small Interbody SystemNu Vasive, Incorporated · 2014 · 2 generations on444descendants
  • K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015 · 2 generations on441descendants
  • K160125Cascadia Interbody SystemK2m · 2016 · 3 generations on315descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−9K990148Stackable Cage SystemDepuy Motech Acromed1999—
−8K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−7K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−6K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−5K033109Ellys and Aurys Vertebral Body ReplacementsScient'X2004—
−4K043479MC+ Partial VBRLdr Spine USA2005—
−3K080728LDR Spine Roi-C ImplantLdr Spine USA2008—
−2K083857LDR Spine Roi-C ImplantLdr Spine USA2009—
−1K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009—
0 (this device)K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013—
+1K140003Coroent Small Interbody SystemNuvasive, Inc.2014—
+2K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014—
+2K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014—
+2K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015—
+3K160125Cascadia Interbody SystemK2m2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
200180
200240
200310
200430
200510
200830
200910
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201440
201520
201640
2017180
2018190
2019320
2020470
2021380
2022520
2023660
2024560
2025610
2026550
FIG. 1 — Lineage of K123206, 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 ODP? 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 ODP device

  1. #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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
*P980048Bak/Cervical (Bak/C) Interbody Fusion System
Summary page 1
…Predicate devices include various cleared interbody fusion systems: - Zimmer Spine: BAlK/C (P980048) - LDR Spine: MC+ (K043479, K(091 088) - Eminent Spine: -Em…
Sulzer Spine-Tech2001—
*K043479MC+ Partial VBR
Summary page 1
…usion systems: - Zimmer Spine: BAlK/C (P980048) - LDR Spine: MC+ (K043479, K(091 088) - Eminent Spine: -Eminent Spine Interbody Fusion System…
Ldr Spine USA2005—
*K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009—
*K090064Eminent Spine Interbody Fusion System
Summary page 1
…LDR Spine: MC+ (K043479, K(091 088) - Eminent Spine: -Eminent Spine Interbody Fusion System (K(090064) - SpineNet, LLC: Daytona Anterior Cervical Cage (K(11073…
Eminent Spine20091
*K110733Daytona Anterior Cervical Cage
Summary page 1
…(K(090064) - SpineNet, LLC: Daytona Anterior Cervical Cage (K(110733) 108…
Spinenet, LLC20111

Also cleared against P980048: 53 other devices →

What descends from it? (454)

See all 454

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

NumberDeviceApplicantDecidedDescendants
K140003Coroent Small Interbody SystemNuvasive, Inc.2014453

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 7 companies; a new generation was cleared every 1.7 years on median.
  • 7 of the 37 ancestors have a recall of any class.
  • Of its descendants, K140003 (Nuvasive, Inc., 2014) has gone furthest, with 453 descendants of its own.
  • 53 other devices also cite its predicate P980048.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2008: 82009: 122010: 92011: 252012: 172013: 182014: 262015: 242016: 172017: 332018: 252019: 222020: 142021: 182022: 122023: 342024: 102025: 112026 (partial year): 19
2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2008: 89 days median2009: 127 days median2010: 151 days median2011: 113 days median2012: 93 days median2013: 187 days median2014: 118 days median2015: 180 days median2016: 112 days median2017: 104 days median2018: 133 days median2019: 92 days median2020: 89 days median2021: 121 days median2022: 92 days median2023: 165 days median2024: 76 days median2025: 87 days median2026 (partial year): 117 days median
2007high 187 (2013) · low 76 (2024)2026

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

Recalls per year · ODP

2in 2025

2009: 12011: 12013: 12020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · ODP

57in 2025

2008: 22009: 212010: 542011: 382012: 922013: 782014: 432015: 512016: 372017: 392018: 512019: 1412020: 862021: 1612022: 502023: 362024: 552025: 57
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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
20070—00
200888902
200912127121
20109151054
201125113138
20121793092
201318187178
201426118043
201524180051
201617112037
201733104039
201825133051
201922920141
20201489186
2021181210161
20221292050
202334165036
20241076055
20251187257
2026191170—

What is it indicated for?

When used as a cervical intervertebral body fusion device, the Maxim Surgical X-Treme Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DOD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the 07-TI disc. DOID is defined as discogenic pain with, degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Indications for use as stated in the FDA summary.

Also cleared against P980048

53 other devices cite the same predicate.

  • K253260ORIO-3D Cage SystemSpineCraft · 2026
  • K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC · 2021
  • K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
  • K182477Cervical SpacerAdditive Implants, LLC · 2019
  • K181471ACCUFUSE Cervical SystemAbsolute Advantage Medical, LLC · 2018
  • K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018

Recent decisions in ODP

The ODP category page

  • K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc. · 2026
  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K2530413d Cage CervicalFims Co., Ltd. · 2026
  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026

https://510kreport.com/device/K123206 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123206: Maxim Surgical X-Treme Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123206

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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