510(k) Report

510(k) · Cleared

Cleared

EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods

K222473510(k) TraditionalCleared Oct 13, 202258-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 Oct 13, 2022 as substantially equivalent to K200245 (Medos International Sàrl, 2020) after a 58-day review. Its family tree reaches back 18 generations to 2004. 1 later device descends from it.

Decided
Oct 13, 2022
Review
58 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
1

Its longest line of descent runs back 18 generations to K040583 (2004). 220 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 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: 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. · 2014K200245 · EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System · Medos International Sàrl · 202019801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 7 other ancestors4 generations back: 40 other ancestors5 generations back: 60 other ancestors6 generations back: 49 other ancestors7 generations back: 28 other ancestors8 generations back: 8 other ancestors9 generations back: 7 other ancestors 1 generation forward: 1 descendant K200245 · EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System · Medos International Sàrl · 2020K142381 · 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 · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 14 generations between
  3. 3 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
  4. 2 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  5. 1 generation backK200245 EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl · 2020
  6. This deviceK222473 EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™…Medos-International Sarl · 2022
  7. Descendant · cites it directly · 0 of its ownK252729 Universal Spinal SystemDouble Medical Technology, Inc. · 2025
Show all 18 generations
  1. Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 17 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 16 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 15 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 14 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 13 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 12 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 11 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 10 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 9 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 8 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 7 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 6 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 5 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 4 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  16. 3 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
  17. 2 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  18. 1 generation backK200245 EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl · 2020
  19. This deviceK222473 EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™…Medos-International Sarl · 2022

Most influential descendants

Showing 1 of 1 · See all
  • K252729Universal Spinal SystemDouble Medical Technology, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−17K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−16K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−15K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−14K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−13K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−12K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−11K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−10K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−9K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−8K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−7K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−6K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−5K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−4K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
−3K140276CD Horizon Spinal SystemMedtronic Sofamor Danek2014—
−2K142381Xia 3 Spinal SystemStryker Corp.2014—
−1K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl2020—
0 (this device)K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl2022—
+1K252729Universal Spinal SystemDouble Medical Technology, Inc.2025—

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
202510
FIG. 1 — Lineage of K222473, 2004–2025Source: 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 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? (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
*K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System
Summary page 5
…erlaminal D. Predicate Device Names Primary Predicate: EXPEDIUM® Spine System and EXPEDIUM VERSE® Spine System (K200245) K222473 Page 1 of 4 E. Device Descri…
Medos International Sàrl2020—

Also cleared against K200245: 4 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K252729Universal Spinal SystemDouble Medical Technology, Inc.20250

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 18 years and passes through 7 companies; a new generation was cleared every 5 months on median.
  • 24 of the 220 ancestors have a recall of any class.
  • Of its descendants, K252729 (Double Medical Technology, Inc., 2025) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K200245.

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. 2022, 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?

EXPEDIUM Spinal System 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…

Read the full statement (359 words)

EXPEDIUM Spinal System

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.

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

EXPEDIUM VERSE Spinal System

The EXPEDIUM VERSE 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 VERSE 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.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM VERSE Spine 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 Spine 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 Spine 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 K200245

4 other devices cite the same predicate.

  • K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  • K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  • K253249TriALTIS™ Spine SystemMedos International SARL · 2025
  • K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL · 2022

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/K222473 · printed Nov 4, 2026

Cite this page

510(k) Report. “K222473: EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222473

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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