510(k) · Cleared
ClearedEXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 8, 2022 as substantially equivalent to K200245 (Medos International Sàrl, 2020) after a 27-day review. Its family tree reaches back 18 generations to 2004. 9 later devices descend from it.
- Decided
- Mar 8, 2022
- Review
- 27 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). 9 later devices descend from it, 1 citing it directly.
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations between
- 3 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- 2 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- 1 generation backK200245 EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl · 2020
- This deviceK220374 EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL · 2022
- Descendant · cites it directly · 8 of its ownK231479 TriALTIS Spine SystemMedos International SARL · 2023
- Descendant · 2 generations on · 4 of its ownK233684 TriALTIS™ Spine SystemMedos International SARL · 2023
- Descendant · 2 generations on · 2 of its ownK253990 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
- Descendant · 3 generations on · 1 of its ownK260786 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
- Descendant · 2 generations on · 1 of its ownK253249 TriALTIS™ Spine SystemMedos International SARL · 2025
Show all 18 generations
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 15 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 13 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 11 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 10 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 9 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 8 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 7 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 6 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 5 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 4 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 3 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- 2 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- 1 generation backK200245 EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl · 2020
- This deviceK220374 EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K231479TriALTIS Spine SystemMedos International SARL · 2023 · cites it directly8descendants
- K233684TriALTIS™ Spine SystemMedos International SARL · 2023 · 2 generations on4descendants
- K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026 · 2 generations on2descendants
- K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026 · 3 generations on1descendant
- K253249TriALTIS™ Spine SystemMedos International SARL · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −15 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −13 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −11 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −10 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −9 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −8 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −7 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −6 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −5 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −4 | K132471 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −3 | K140276 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2014 | — |
| −2 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| −1 | K200245 | EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System | Medos International Sàrl | 2020 | — |
| 0 (this device) | K220374 | EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) | Medos International SARL | 2022 | — |
| +1 | K231479 | TriALTIS Spine System | Medos International SARL | 2023 | — |
| +2 | K233684 | TriALTIS™ Spine System | Medos International SARL | 2023 | — |
| +2 | K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | — |
| +3 | K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | — |
| +2 | K253249 | TriALTIS™ Spine System | Medos International SARL | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 10 | 0 |
| 1999 | 10 | 0 |
| 2000 | 16 | 0 |
| 2001 | 20 | 0 |
| 2002 | 10 | 0 |
| 2003 | 14 | 0 |
| 2004 | 21 | 0 |
| 2005 | 22 | 0 |
| 2006 | 15 | 0 |
| 2007 | 8 | 0 |
| 2008 | 8 | 0 |
| 2009 | 7 | 0 |
| 2010 | 8 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 0 |
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 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K200245 | EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemSummary page 5…888.3050 Product Codes: NKB, KWQ, KWP D. Predicate Device Names Predicate: EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System – K200245 Device Description Summary The EXPEDIUM fenestrated screws are polyaxial pedicle screws designed with a cannulation that runs the… | 2020 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231479 | TriALTIS Spine System | 2023 | 8 |
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, K231479 (Medos International SARL, 2023) has gone furthest, with 8 descendants of its own.
- 4 other devices also cite its predicate K200245.
How does its category compare?
All NKB devicesNKB 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
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
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…
Read the full statement (404 words)
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 adolescent idiopathic scoliosis. The EXPEDIUM Verse system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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.
When used in conjunction with CONFIDENCE High Viscosity Spinal Cement, the EXPEDIUM VERSE Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The EXPEDIUM Fenestrated Screw System augmented with the CONFIDENCE High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220374 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220374: EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220374
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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