510(k) · Cleared
ClearedExpedium 4.5MM Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 4, 2008 as substantially equivalent to K071495 (Depuy Spine, A Johnson & Johnson Company, 2007) and 4 other predicates after a 126-day review. Its family tree reaches back 3 generations to 1996. 1 of the 545 devices in its family, counting itself, has a Class I recall. 538 later devices descend from it.
- Decided
- Apr 4, 2008
- Review
- 126 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K955348 (1996). 6 ancestors in all. 538 later devices descend from it, 11 citing it directly. 1 of the 545 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- 2 generations backK062196 SFX Snap-Fit Cross ConnectorDepuy Spine, Inc. · 2006
- 1 generation backK071495 Expedium 4.5MM Spine SystemDepuy Spine, A Johnson & Johnson Company · 2007
- This deviceK073364 Expedium 4.5MM Spine SystemDepuy Spine, Inc. · 2008
- Descendant · cites it directly · 518 of its ownK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- Descendant · cites it directly · 462 of its ownK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
- Descendant · cites it directly · 337 of its ownK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
- Descendant · cites it directly · 263 of its ownK092473 Expedium Spine SystemDepuy Spine, Inc. · 2009
- Descendant · 2 generations on · 260 of its ownK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
Showing 5 of 538 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 538 · See all- K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008 · cites it directly518descendants
- K090230Expedium Spine SystemDepuy Spine, Inc. · 2009 · cites it directly462descendants
- K090648Viper 2 SystemDepuy Spine, Inc. · 2009 · cites it directly337descendants
- K092473Expedium Spine SystemDepuy Spine, Inc. · 2009 · cites it directly263descendants
- K101070Expedium Spine SystemMedos International SARL · 2010 · 2 generations on260descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| −2 | K062196 | SFX Snap-Fit Cross Connector | Depuy Spine, Inc. | 2006 | — |
| −1 | K071495 | Expedium 4.5MM Spine System | Depuy Spine, A Johnson & Johnson Company | 2007 | — |
| 0 (this device) | K073364 | Expedium 4.5MM Spine System | Depuy Spine, Inc. | 2008 | — |
| +1 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| +1 | K090230 | Expedium Spine System | Depuy Spine, Inc. | 2009 | — |
| +1 | K090648 | Viper 2 System | Depuy Spine, Inc. | 2009 | — |
| +1 | K092473 | Expedium Spine System | Depuy Spine, Inc. | 2009 | — |
| +2 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 19 | 0 |
| 2013 | 28 | 0 |
| 2014 | 18 | 0 |
| 2015 | 28 | 0 |
| 2016 | 22 | 0 |
| 2017 | 37 | 0 |
| 2018 | 37 | 0 |
| 2019 | 35 | 0 |
| 2020 | 34 | 0 |
| 2021 | 26 | 1 |
| 2022 | 34 | 0 |
| 2023 | 55 | 0 |
| 2024 | 52 | 0 |
| 2025 | 44 | 0 |
| 2026 | 45 | 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.
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 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? (5)
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 |
|---|---|---|---|
| * | K071495 | Expedium 4.5MM Spine SystemSummary page 1…Product Code(s): NKB, MNH, MNI, KWP, KWQ Proprietary Name: EXPEDILUM Spine System Predicate Devices: EXPEDIUM 4.5mim Spine System (K07 1495) EXPEDTUM 5.5mm Spine System (K033901) EXPEDIUM 5.5mm Spine S… | 2007 |
| * | K033901 | Merlin Spine SystemSummary page 1…ry Name: EXPEDILUM Spine System Predicate Devices: EXPEDIUM 4.5mim Spine System (K07 1495) EXPEDTUM 5.5mm Spine System (K033901) EXPEDIUM 5.5mm Spine System (KO41 119) Moss" Miami Spine Sys… | 2004 |
| * | K041119 | Expedium Spine System | 2004 |
| * | K011182 | Modified Moss Miami 4.35MM Diameter Polyaxial Screws | 2001 |
| * | K062196 | SFX Snap-Fit Cross ConnectorSummary page 1…mm Spine System (KO41 119) Moss" Miami Spine System (KOl11 182) EXPEDIiUM SFX Cross Connector System (K062 196) Device Description: The subject EXPEDIUMTM Spine System components are designed t… | 2006 |
What descends from it? (538)
See all 53811 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082942 | Modfication to: Expedium Spine System | 2008 | 518 |
| K090230 | Expedium Spine System | 2009 | 462 |
| K090648 | Viper 2 System | 2009 | 337 |
| K092473 | Expedium Spine System | 2009 | 263 |
| K081898 | Expedium Spine System | 2008 | 59 |
| K123352 | S4 Spinal System | 2012 | 51 |
| K130291 | S4 Spinal System | 2013 | 44 |
| K081252 | Expedium 4.5MM Spine System | 2008 | 44 |
| K130877 | Expedium Spine System | 2013 | 8 |
| K162134 | ENNOVATE Spinal System | 2016 | 2 |
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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K082942 (Depuy Spine, Inc., 2008) has gone furthest, with 518 descendants of its own.
- 7 other devices also cite its predicate K071495.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 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 (98 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073364: Expedium 4.5MM 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/K073364
Report an extraction error
Are you the manufacturer?
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