510(k) Report

510(k) · Cleared

Cleared

Expedium Spine System

K090230510(k) SpecialCleared Mar 6, 200935-day reviewClass II21 CFR 888.3070

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

Depuy Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Mar 6, 2009 as substantially equivalent to K082942 (Depuy Spine, Inc., 2008) and 9 other predicates after a 35-day review. Its family tree reaches back 6 generations to 1995. 1 of the 495 devices in its family, counting itself, has a Class I recall. 462 later devices descend from it.

Decided
Mar 6, 2009
Review
35 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
10

Its longest line of descent runs back 6 generations to K950697 (1995). 32 ancestors in all, the oldest K933881 (1994). 462 later devices descend from it, 14 citing it directly. 1 of the 495 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2008: 2 other ancestors2005: 2 other ancestors2004: 5 other ancestors1998: 1 other ancestor1997: 1 other ancestor1994: 1 other ancestor2007: 2 other ancestors2006: 1 other ancestor2003: 4 other ancestors2002: 1 other ancestor2001: 3 other ancestors1999: 1 other ancestor1996: 1 other ancestor2000: 1 other ancestor2017: 36 descendants cleared2013: 25 descendants cleared2010: 3 descendants cleared2019: 26 descendants cleared2009: 2 descendants cleared2016: 17 descendants cleared2011: 4 descendants cleared2012: 9 descendants cleared2014: 16 descendants cleared2018: 32 descendants cleared2015: 24 descendants cleared2021: 22 descendants cleared, 1 with a Class I recall12020: 32 descendants cleared2023: 48 descendants cleared2024: 51 descendants cleared2022: 30 descendants cleared2025: 44 descendants cleared2026: 41 descendants clearedK950697 · Depuy Motech Moss Miami Spinal System - Pedicle Fixation · Depuy Motech · 1995×2: 2 generations cleared close together, K050461 (2005), K052761 (2005) ×2: 2 generations cleared close together, K060361 (2006), K060979 (2006) K082942 · Modfication to: Expedium Spine System · Depuy Spine, Inc. · 20081990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 10 other ancestors3 generations back: 4 other ancestors4 generations back: 3 other ancestors5 generations back: 1 other ancestor 1 generation forward: 14 descendants2 generations forward: 40 descendants3 generations forward: 60 descendants4 generations forward: 126 descendants5 generations forward: 112 descendants, 1 with a Class I recall16 generations forward: 50 descendants7 generations forward: 26 descendants8 generations forward: 19 descendants9 generations forward: 12 descendants10 generations forward: 3 descendants K082942 · Modfication to: Expedium Spine System · Depuy Spine, Inc. · 2008K060979 · Xia Titanium and 4.5 Spinal Systems · Stryker Spine · 2006K060361 · Xia Spinal System, Xia 4.5 Spinal System · Stryker Spine · 2006 · recalledK052761 · Modification to: Xia 4.5 Spinal System · Stryker Spine · 2005K050461 · Xia 4.5 Spinal System · Stryker Spine · 2005K950697 · Depuy Motech Moss Miami Spinal System - Pedicle Fixation · Depuy Motech · 1995−50+5+10
  1. Root · 6 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
  2. 5 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
  3. 4 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
  4. 3 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
  5. 2 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
  6. 1 generation backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
  7. This deviceK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
  8. Descendant · cites it directly · 263 of its ownK092473 Expedium Spine SystemDepuy Spine, Inc. · 2009
  9. Descendant · cites it directly · 260 of its ownK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
  10. Descendant · 2 generations on · 225 of its ownK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
  11. Descendant · cites it directly · 184 of its ownK102701 Viper Spine SystemDepuy Spine, Inc. · 2010
  12. Descendant · 3 generations on · 172 of its ownK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013

Showing 5 of 462 descendants. See all descendants

Descendants cleared per year

2009: 22010: 32011: 42012: 92013: 252014: 162015: 242016: 172017: 362018: 322019: 262020: 322021: 222022: 302023: 482024: 512025: 442026: 41
2009high 51 (2024) · low 2 (2009)2026

Class I recalls in this family

  • K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 462 · See all
  • K092473Expedium Spine SystemDepuy Spine, Inc. · 2009 · cites it directly263descendants
  • K101070Expedium Spine SystemMedos International SARL · 2010 · cites it directly260descendants
  • K122226Revere Stabilization SystemGlobus Medical, Inc. · 2012 · 2 generations on225descendants
  • K102701Viper Spine SystemDepuy Spine, Inc. · 2010 · cites it directly184descendants
  • K124058Creo Stabilization SystemGlobus Medical, Inc. · 2013 · 3 generations on172descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K950697Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech1995—
−5K050461Xia 4.5 Spinal SystemStryker Spine2005—
−4K052761Modification to: Xia 4.5 Spinal SystemStryker Spine2005—
−3K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine20061
−2K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006—
−1K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008—
0 (this device)K090230Expedium Spine SystemDepuy Spine, Inc.2009—
+1K092473Expedium Spine SystemDepuy Spine, Inc.2009—
+1K101070Expedium Spine SystemMedos International SARL20101
+2K122226Revere Stabilization SystemGlobus Medical, Inc.2012—
+1K102701Viper Spine SystemDepuy Spine, Inc.2010—
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199610
199710
199810
199910
200010
200130
200210
200340
200450
200520
200610
200720
200820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201030
201140
201290
2013250
2014160
2015240
2016170
2017360
2018320
2019260
2020320
2021221
2022300
2023480
2024510
2025440
2026410
FIG. 1 — Lineage of K090230, 1995–2026Source: 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.

1 device in this family has a Class I recall. 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 NKB device

  1. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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? (10)

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
*K082942Modfication to: Expedium Spine System
Summary page 1
…Product Code(s): NKB, KWQ, KWP, MNH, MNI Proprietary Name: EXPEDIUM Spine System Predicate Devices: EXPEDIJMTM Spine System (K082942, K033901, K041119, K073364) MOSS MIAMI Spine System (K9…
Depuy Spine, Inc.2008—
*K033901Merlin Spine System
Summary page 1
…uct Code(s): NKB, KWQ, KWP, MNH, MNI Proprietary Name: EXPEDIUM Spine System Predicate Devices: EXPEDIJMTM Spine System (K082942, K033901, K041119, K073364) MOSS MIAMI Spine System (K933881, K9…
Depuy Spine, Inc.2004—
*K041119Expedium Spine System
Summary page 1
…Proprietary Name: EXPEDIUM Spine System Predicate Devices: EXPEDIJMTM Spine System (K082942, K033901, K041119, K073364) MOSS MIAMI Spine System (K933881, K962628, K9…
Depuy Spine, Inc.2004—
*K073364Expedium 4.5MM Spine System
Summary page 1
…Proprietary Name: EXPEDIUM Spine System Predicate Devices: EXPEDIJMTM Spine System (K082942, K033901, K041119, K073364) MOSS MIAMI Spine System (K933881, K962628, K983583)…
Depuy Spine, Inc.2008—
*K933881Depuy Motech Moss-Miami Spinal System
Summary page 1
…evices: EXPEDIJMTM Spine System (K082942, K033901, K041119, K073364) MOSS MIAMI Spine System (K933881, K962628, K983583) Stryker Spine Xia and Xia 4.5 Spinal…
Depuy, Inc.1994—
*K962628Moss Miami Spinal System
Summary page 1
…EXPEDIJMTM Spine System (K082942, K033901, K041119, K073364) MOSS MIAMI Spine System (K933881, K962628, K983583) Stryker Spine Xia and Xia 4.5 Spinal System (…
Depuy, Inc.1997—
*K983583Depuy Acromed Moss and Moss Miami Spinal Systems
Summary page 1
…K041119, K073364) MOSS MIAMI Spine System (K933881, K962628, K983583) Stryker Spine Xia and Xia 4.5 Spinal System (K060979)…
Depuy, Inc.1998—
*K060979Xia Titanium and 4.5 Spinal Systems
Summary page 1
…OSS MIAMI Spine System (K933881, K962628, K983583) Stryker Spine Xia and Xia 4.5 Spinal System (K060979) CD Horizon Spinal System (K043488) K2M CoCr Rod (K0807…
Stryker Spine2006—
*K043488Modification to CD Horizon Spinal System
Summary page 1
…K983583) Stryker Spine Xia and Xia 4.5 Spinal System (K060979) CD Horizon Spinal System (K043488) K2M CoCr Rod (K080792) Device Description: The subject EXPEDIUM Spine Syst…
Medtronic Sofamor Danek2005—
*K080792K2M Cocr Rod
Summary page 1
…Spine Xia and Xia 4.5 Spinal System (K060979) CD Horizon Spinal System (K043488) K2M CoCr Rod (K080792) Device Description: The subject EXPEDIUM Spine System components consist of…
K2m, Inc.2008—

Also cleared against K082942: 6 other devices →

What descends from it? (462)

See all 462

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

NumberDeviceApplicantDecidedDescendants
K092473Expedium Spine SystemDepuy Spine, Inc.2009263
K101070Expedium Spine SystemMedos International SARL2010260
K102701Viper Spine SystemDepuy Spine, Inc.2010184
K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems201092
K0910675.5 Polaris Spinal SystemBiomet Spine200979
K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253
K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739
K122877Range Spinal System, Small StatureK2m, Inc.201334
K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913
K130877Expedium Spine SystemMedos International SARL20138

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 5 months on median.
  • 2 of the 32 ancestors have a recall of any class.
  • Of its descendants, K092473 (Depuy Spine, Inc., 2009) has gone furthest, with 263 descendants of its own.
  • 6 other devices also cite its predicate K082942.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

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

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, 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
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin…

Read the full statement (102 words)

The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

Indications for use as stated in the FDA summary.

Also cleared against K082942

6 other devices cite the same predicate.

  • K180337EUROPA Pedicle Screw SystemMiRus, LLC · 2019
  • K182970EUROPA™ Pedicle Screw SystemMiRus, LLC · 2019
  • K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2016
  • K130877Expedium Spine SystemMedos International SARL · 2013
  • K0910675.5 Polaris Spinal SystemBiomet Spine · 2009
  • K090648Viper 2 SystemDepuy Spine, Inc. · 2009

More from Depuy Spine, Inc.

86 FDA decisions under this applicant name. See the company

  • K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc. · 2020
  • K142185Expedium Verse Spine SystemDepuy Spine, Inc. · 2014
  • K111136Expedium Spine System, Viper System, Viper 2 SystemDepuy Spine, Inc. · 20121 recall
  • K121020Viper SystemDepuy Spine, Inc. · 2012
  • K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K090230 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090230: Expedium Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090230

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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