510(k) Report

510(k) · Cleared

Cleared

EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System

K200245510(k) TraditionalCleared Apr 24, 202084-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 Sàrl · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Apr 24, 2020 as substantially equivalent to K162494 (Medtronic Sofamor Danek USA, Inc., 2016) and 3 other predicates after an 84-day review. Its family tree reaches back 17 generations to 2004. 12 later devices descend from it.

Decided
Apr 24, 2020
Review
84 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
4

Its longest line of descent runs back 17 generations to K040583 (2004). 219 ancestors in all, the oldest K781443 (1978). 12 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2016: 2 other ancestors2014: 1 other ancestor2013: 3 other ancestors2012: 3 other ancestors2007: 8 other ancestors2004: 21 other ancestors2011: 5 other ancestors2010: 8 other ancestors2009: 7 other ancestors2008: 8 other ancestors2006: 15 other ancestors2005: 22 other ancestors2003: 14 other ancestors2001: 20 other ancestors2000: 16 other ancestors1998: 10 other ancestors2002: 10 other ancestors1999: 10 other ancestors1997: 4 other ancestors1996: 5 other ancestors1995: 5 other ancestors1978: 1 other ancestor1993: 2 other ancestors1984: 1 other ancestor1985: 1 other ancestor2025: 3 descendants cleared2022: 2 descendants cleared2026: 4 descendants cleared2023: 2 descendants cleared2024: 1 descendant cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012×3: 3 generations cleared close together, K131321 (2013), K132471 (2013), K140276 (2014) K142381 · Xia 3 Spinal System · Stryker Corp. · 201419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 7 other ancestors3 generations back: 40 other ancestors4 generations back: 60 other ancestors5 generations back: 49 other ancestors6 generations back: 28 other ancestors7 generations back: 8 other ancestors8 generations back: 7 other ancestors 1 generation forward: 5 descendants2 generations forward: 4 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K142381 · Xia 3 Spinal System · Stryker Corp. · 2014K140276 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2014K132471 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2013K131321 · CD Horizon Spinal System · Medtronic Sofamor Danek USA · 2013K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−15−10−50
  1. Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 13 generations between
  3. 3 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  4. 2 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
  5. 1 generation backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  6. This deviceK200245 EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl · 2020
  7. Descendant · cites it directly · 9 of its ownK220374 EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL · 2022
  8. Descendant · 2 generations on · 8 of its ownK231479 TriALTIS Spine SystemMedos International SARL · 2023
  9. Descendant · 3 generations on · 4 of its ownK233684 TriALTIS™ Spine SystemMedos International SARL · 2023
  10. Descendant · cites it directly · 2 of its ownK253990 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  11. Descendant · 2 generations on · 1 of its ownK260786 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
Show all 17 generations
  1. Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 5 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 4 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 3 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  16. 2 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
  17. 1 generation backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  18. This deviceK200245 EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl · 2020

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2022: 22023: 22024: 12025: 32026: 4
2022high 4 (2026) · low 1 (2024)2026

Most influential descendants

Showing 5 of 12 · See all
  • K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL · 2022 · cites it directly9descendants
  • K231479TriALTIS Spine SystemMedos International SARL · 2023 · 2 generations on8descendants
  • K233684TriALTIS™ Spine SystemMedos International SARL · 2023 · 3 generations on4descendants
  • K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026 · cites it directly2descendants
  • K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−17K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−16K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−15K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−14K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−13K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−12K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−11K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−10K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−9K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−8K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−7K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−6K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−5K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−4K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−3K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
−2K140276CD Horizon Spinal SystemMedtronic Sofamor Danek2014—
−1K142381Xia 3 Spinal SystemStryker Corp.2014—
0 (this device)K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl2020—
+1K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL2022—
+2K231479TriALTIS Spine SystemMedos International SARL2023—
+3K233684TriALTIS™ Spine SystemMedos International SARL2023—
+1K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026—
+2K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199320
199550
199650
199740
1998100
1999100
2000160
2001200
2002100
2003140
2004210
2005220
2006150
200780
200880
200970
201080
201150
201230
201330
201410
201620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202220
202320
202410
202530
202640
FIG. 1 — Lineage of K200245, 2004–2026Source: 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 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? (4)

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
*K162494CD HORIZON® Spinal System
Summary page 5
…Codes: KWP, KWQ Review Panel: Orthopedic D. Predicate Devices Name Primary Predicate: CD HORIZON® Spinal System (K162494) Additional Predicates: Xia® 3 and Xia® 4.5 Spinal Systems (K142381) EXPEDIUM® Spine System (K…
Medtronic Sofamor Danek USA, Inc.2016—
*K142381Xia 3 Spinal System
Summary page 5
…opedic D. Predicate Devices Name Primary Predicate: CD HORIZON® Spinal System (K162494) Additional Predicates: Xia® 3 and Xia® 4.5 Spinal Systems (K142381) EXPEDIUM® Spine System (K160904) EXPEDIUM VERSE® Spine System (K14218…
Stryker Corp.2014—
*K160904Expedium Spine System, VIPER and VIPER 2 Systems
Summary page 5
…CD HORIZON® Spinal System (K162494) Additional Predicates: Xia® 3 and Xia® 4.5 Spinal Systems (K142381) EXPEDIUM® Spine System (K160904) EXPEDIUM VERSE® Spine System (K142185)…
Medos International SARL2016—
*K142185Expedium Verse Spine System
Summary page 5
…s: Xia® 3 and Xia® 4.5 Spinal Systems (K142381) EXPEDIUM® Spine System (K160904) EXPEDIUM VERSE® Spine System (K142185) K200245…
Depuy Spine, Inc.2014—

Also cleared against K162494: 4 other devices →

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229
K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262
K253249TriALTIS™ Spine SystemMedos International SARL20251
K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221
K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260

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 16 years and passes through 6 companies; a new generation was cleared every 5 months on median.
  • 24 of the 219 ancestors have a recall of any class.
  • Of its descendants, K220374 (Medos International SARL, 2022) has gone furthest, with 9 descendants of its own.
  • 4 other devices also cite its predicate K162494.

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. 2020, 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…

Read the full statement (453 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM® System is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e, scoliosis, kyphosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the EXPEDIUM® System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The EXPEDIUM® System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM VERSE® 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 VERSE® 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, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the EXPEDIUM VERSE® 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, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM VERSE® System metallic implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e, scoliosis, kyphosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the EXPEDIUM VERSE® system is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The EXPEDIUM VERSE® system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Indications for use as stated in the FDA summary.

Also cleared against K162494

4 other devices cite the same predicate.

  • K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda · 2023
  • K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC · 2018
  • K170266Palisade™ Pedicular Fixation SystemSpineology, Inc. · 2017
  • K170268Fortress™ Pedicular Fixation SystemSpineology, Inc. · 2017

More from Medos International Sàrl

4 FDA decisions under this applicant name. See the company

  • K231527TriALTIS Navigation Enabled InstrumentsMedos International Sàrl · 2023
  • K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl · 2023
  • K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl · 2016

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/K200245 · printed Nov 6, 2026

Cite this page

510(k) Report. “K200245: EXPEDIUM® Spine System; EXPEDIUM VERSE® 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/K200245

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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