510(k) Report

510(k) · Cleared

Cleared

Expedium Spine System

K130877510(k) TraditionalCleared Jun 20, 201383-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

Medos International SARL · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jun 20, 2013 as substantially equivalent to K041119 (Depuy Spine, Inc., 2004) and 7 other predicates after an 83-day review. Its family tree reaches back 13 generations to 1985. 8 later devices descend from it.

Decided
Jun 20, 2013
Review
83 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
8

Its longest line of descent runs back 13 generations to K853033 (1985). 79 ancestors in all. 8 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2009: 2 other ancestors2008: 4 other ancestors2007: 4 other ancestors2004: 5 other ancestors2006: 3 other ancestors2005: 6 other ancestors2003: 6 other ancestors2002: 4 other ancestors2001: 9 other ancestors1999: 7 other ancestors1998: 4 other ancestors1997: 2 other ancestors1995: 3 other ancestors1994: 1 other ancestor1996: 3 other ancestors2000: 2 other ancestors2017: 1 descendant cleared2014: 1 descendant cleared2013: 1 descendant cleared2021: 1 descendant cleared2020: 1 descendant cleared2016: 1 descendant cleared2024: 2 descendants clearedK853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004×3: 3 generations cleared close together, K062174 (2006), K063156 (2006), K063741 (2007) K080313 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2008K101070 · Expedium Spine System · Medos International SARL · 2010 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 21 other ancestors3 generations back: 17 other ancestors4 generations back: 14 other ancestors5 generations back: 6 other ancestors6 generations back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K101070 · Expedium Spine System · Medos International SARL · 2010 · recalledK080313 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2008K063741 · Expedium Spine System · Depuy Spine, Inc. · 2007K063156 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K062174 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985−10−50
  1. Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 9 generations between
  3. 3 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
  4. 2 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
  5. 1 generation backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
  6. This deviceK130877 Expedium Spine SystemMedos International SARL · 2013
  7. Descendant · cites it directly · 2 of its ownK170163 Erisma® LP Spinal Fixation SystemClariance, Sas · 2017
  8. Descendant · cites it directly · 2 of its ownK141291 Vertiform Posterior Fixation SystemNext Orthosurgical · 2014
  9. Descendant · 2 generations on · 1 of its ownK240872 Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance · 2024
  10. Descendant · 2 generations on · 1 of its ownK161499 VertiForm Posterior Fixation SystemNext Orthosurgical · 2016
  11. Descendant · 3 generations on · 0 of its ownK241863 Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance · 2024
Show all 13 generations
  1. Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 12 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 11 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 10 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 9 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 8 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 7 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 6 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 5 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  10. 4 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  11. 3 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
  12. 2 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
  13. 1 generation backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
  14. This deviceK130877 Expedium Spine SystemMedos International SARL · 2013

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12016: 12017: 12020: 12021: 12024: 2
2013high 2 (2024) · low 0 (2015)2026

Most influential descendants

Showing 5 of 8 · See all
  • K170163Erisma® LP Spinal Fixation SystemClariance, Sas · 2017 · cites it directly2descendants
  • K141291Vertiform Posterior Fixation SystemNext Orthosurgical · 2014 · cites it directly2descendants
  • K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance · 2024 · 2 generations on1descendant
  • K161499VertiForm Posterior Fixation SystemNext Orthosurgical · 2016 · 2 generations on1descendant
  • K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−12K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−11K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−10K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−9K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−8K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−7K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−6K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−5K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−4K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−3K063741Expedium Spine SystemDepuy Spine, Inc.2007—
−2K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008—
−1K101070Expedium Spine SystemMedos International SARL20101
0 (this device)K130877Expedium Spine SystemMedos International SARL2013—
+1K170163Erisma® LP Spinal Fixation SystemClariance, Sas2017—
+1K141291Vertiform Posterior Fixation SystemNext Orthosurgical2014—
+2K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance2024—
+2K161499VertiForm Posterior Fixation SystemNext Orthosurgical2016—
+3K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199530
199630
199720
199840
199970
200020
200190
200240
200360
200450
200560
200630
200740
200840
200920
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201610
201710
202010
202110
202420
FIG. 1 — Lineage of K130877, 1985–2024Source: 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 NKB? 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? (8)

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
*K041119Expedium Spine System
Summary page 2
…icle screw spinal fixation per 21 CFR §888.3070, MNH, MNI, NKB, OSH Page 1 of 3 D. K130877 Predicate Device Name Trade name: EXPEDIUM® Spine System (K041119) EXPEDIUM® Spine System {K062174) EXPEDIUM® Spine System (K071495) EXPEDIUM® Spine System (K073364) EXPEDIUM® Spine System (K0829…
Depuy Spine, Inc.2004—
*K062174Modification to Expedium Spine System
Summary page 2
…1 CFR §888.3070, MNH, MNI, NKB, OSH Page 1 of 3 D. K130877 Predicate Device Name Trade name: EXPEDIUM® Spine System (K041119) EXPEDIUM® Spine System {K062174) EXPEDIUM® Spine System (K071495) EXPEDIUM® Spine System (K073364) EXPEDIUM® Spine System (K082942) EXPEDIUM® Spine System (K0902…
Depuy Spine, Inc.2006—
*K071495Expedium 4.5MM Spine System
Summary page 2
…SH Page 1 of 3 D. K130877 Predicate Device Name Trade name: EXPEDIUM® Spine System (K041119) EXPEDIUM® Spine System {K062174) EXPEDIUM® Spine System (K071495) EXPEDIUM® Spine System (K073364) EXPEDIUM® Spine System (K082942) EXPEDIUM® Spine System (K090230) EXPEDIUM® Spine System (K1010…
Depuy Spine, A Johnson & Johnson Company2007—
*K073364Expedium 4.5MM Spine System
Summary page 2
…. K130877 Predicate Device Name Trade name: EXPEDIUM® Spine System (K041119) EXPEDIUM® Spine System {K062174) EXPEDIUM® Spine System (K071495) EXPEDIUM® Spine System (K073364) EXPEDIUM® Spine System (K082942) EXPEDIUM® Spine System (K090230) EXPEDIUM® Spine System (K101070) EXPEDIUM® Spine System (K1111…
Depuy Spine, Inc.2008—
*K082942Modfication to: Expedium Spine System
Summary page 2
…Trade name: EXPEDIUM® Spine System (K041119) EXPEDIUM® Spine System {K062174) EXPEDIUM® Spine System (K071495) EXPEDIUM® Spine System (K073364) EXPEDIUM® Spine System (K082942) EXPEDIUM® Spine System (K090230) EXPEDIUM® Spine System (K101070) EXPEDIUM® Spine System (K111136) Device Description The subj…
Depuy Spine, Inc.2008—
*K090230Expedium Spine System
Summary page 2
…tem (K041119) EXPEDIUM® Spine System {K062174) EXPEDIUM® Spine System (K071495) EXPEDIUM® Spine System (K073364) EXPEDIUM® Spine System (K082942) EXPEDIUM® Spine System (K090230) EXPEDIUM® Spine System (K101070) EXPEDIUM® Spine System (K111136) Device Description The subject additions to the EXPEDIUM 4.5…
Depuy Spine, Inc.2009—
*K101070Expedium Spine System
Summary page 2
…tem {K062174) EXPEDIUM® Spine System (K071495) EXPEDIUM® Spine System (K073364) EXPEDIUM® Spine System (K082942) EXPEDIUM® Spine System (K090230) EXPEDIUM® Spine System (K101070) EXPEDIUM® Spine System (K111136) Device Description The subject additions to the EXPEDIUM 4.5mm, 5.5mm, and 6.35mm Spine Syste…
Medos International SARL20101
*K111136Expedium Spine System, Viper System, Viper 2 System
Summary page 2
…tem (K071495) EXPEDIUM® Spine System (K073364) EXPEDIUM® Spine System (K082942) EXPEDIUM® Spine System (K090230) EXPEDIUM® Spine System (K101070) EXPEDIUM® Spine System (K111136) Device Description The subject additions to the EXPEDIUM 4.5mm, 5.5mm, and 6.35mm Spine Systemns consist of open angled extend…
Depuy Spine, Inc.20121

Also cleared against K041119: 28 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172
K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142
K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210
K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130

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 28 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
  • 4 of the 79 ancestors have a recall of any class.
  • Of its descendants, K170163 (Clariance, Sas, 2017) has gone furthest, with 2 descendants of its own.
  • 28 other devices also cite its predicate K041119.

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. 2013, 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 (152 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 {ordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K041119

28 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
  • K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG · 2016
  • K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

More from Medos International SARL

96 FDA decisions under this applicant name. See the company

  • K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL · 2026
  • K260240SYMPHONY Navigation Ready InstrumentsMedos International SARL · 2026
  • K253249TriALTIS™ Spine SystemMedos International SARL · 2025
  • K243249TriALTIS™ Spine SystemMedos International SARL · 2025
  • K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL · 2024

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/K130877 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130877: 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/K130877

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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