510(k) · Cleared
ClearedModfication to: Expedium 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 Oct 31, 2008 as substantially equivalent to K033901 (Depuy Spine, Inc., 2004) and 5 other predicates after a 29-day review. Its family tree reaches back 5 generations to 1995. 1 of the 548 devices in its family, counting itself, has a Class I recall. 518 later devices descend from it.
- Decided
- Oct 31, 2008
- Review
- 29 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K950697 (1995). 29 ancestors in all. 518 later devices descend from it, 7 citing it directly. 1 of the 548 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 4 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 3 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 2 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 1 generation backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- This deviceK082942 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 · 2 generations on · 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
- Descendant · 3 generations on · 225 of its ownK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
Showing 5 of 518 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 518 · See all- K090230Expedium Spine SystemDepuy Spine, Inc. · 2009 · cites it directly462descendants
- K090648Viper 2 SystemDepuy Spine, Inc. · 2009 · cites it directly337descendants
- K092473Expedium Spine SystemDepuy Spine, Inc. · 2009 · 2 generations on263descendants
- K101070Expedium Spine SystemMedos International SARL · 2010 · 2 generations on260descendants
- K122226Revere Stabilization SystemGlobus Medical, Inc. · 2012 · 3 generations on225descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −4 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −3 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −2 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −1 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| 0 (this device) | 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 | — |
| +2 | K092473 | Expedium Spine System | Depuy Spine, Inc. | 2009 | — |
| +2 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| +3 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 7 | 0 |
| 2012 | 17 | 0 |
| 2013 | 27 | 0 |
| 2014 | 18 | 0 |
| 2015 | 26 | 0 |
| 2016 | 19 | 0 |
| 2017 | 37 | 0 |
| 2018 | 37 | 0 |
| 2019 | 35 | 0 |
| 2020 | 34 | 0 |
| 2021 | 24 | 1 |
| 2022 | 33 | 0 |
| 2023 | 54 | 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? (6)
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 |
|---|---|---|---|
| * | K033901 | Merlin Spine SystemSummary page 1…l Number: 87 Product Code(s): NKB, KWQ, KWP, MNH, MINI Proprietary Name: EXPEDIUM Spine System Predicate Devices: EXPEDTUM TM Spine System (K033901; K041 119; K073364) Stryker Spine Xia and Xia 4.5 Spinal System (K060979)… | 2004 |
| * | K041119 | Expedium Spine SystemSummary page 1…87 Product Code(s): NKB, KWQ, KWP, MNH, MINI Proprietary Name: EXPEDIUM Spine System Predicate Devices: EXPEDTUM TM Spine System (K033901; K041 119; K073364) Stryker Spine Xia and Xia 4.5 Spinal System (K060979)… | 2004 |
| * | K073364 | Expedium 4.5MM Spine SystemSummary page 1…KWQ, KWP, MNH, MINI Proprietary Name: EXPEDIUM Spine System Predicate Devices: EXPEDTUM TM Spine System (K033901; K041 119; K073364) Stryker Spine Xia and Xia 4.5 Spinal System (K060979) CD Horizon Spinal Sy… | 2008 |
| * | K060979 | Xia Titanium and 4.5 Spinal SystemsSummary page 1…cate Devices: EXPEDTUM TM Spine System (K033901; K041 119; K073364) Stryker Spine Xia and Xia 4.5 Spinal System (K060979) CD Horizon Spinal System (K043488) K2M CoCr Rod (K080792) Device Des… | 2006 |
| * | K043488 | Modification to CD Horizon Spinal SystemSummary page 1…K073364) Stryker Spine Xia and Xia 4.5 Spinal System (K060979) CD Horizon Spinal System (K043488) K2M CoCr Rod (K080792) Device Description: The subject EXPEDIUM Spine System components consist… | 2005 |
| * | K080792 | K2M Cocr RodSummary page 1…Stryker Spine Xia and Xia 4.5 Spinal System (K060979) CD Horizon Spinal System (K043488) K2M CoCr Rod (K080792) Device Description: The subject EXPEDIUM Spine System components consist of 5.5mm rods and are av… | 2008 |
What descends from it? (518)
See all 5187 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 3 companies; a new generation was cleared every 5 months on median.
- 2 of the 29 ancestors have a recall of any class.
- Of its descendants, K090230 (Depuy Spine, Inc., 2009) has gone furthest, with 462 descendants of its own.
- 34 other devices also cite its predicate K033901.
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 EXPEDIJMTM 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 (102 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 EXPEDIJMTM 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082942: Modfication to: 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/K082942
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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