510(k) · Cleared
ClearedModifications 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 Sep 3, 2008 as substantially equivalent to K073126 (Depuy Spine, Inc., 2007) and 1 other predicate after a 30-day review. Its family tree reaches back 5 generations to 1995. 1 of the 288 devices in its family, counting itself, has a Class I recall. 269 later devices descend from it.
- Decided
- Sep 3, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K944736 (1995). 18 ancestors in all. 269 later devices descend from it, 2 citing it directly. 1 of the 288 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK944736 VSP (Variable Screw Placement)Acromed Corp. · 1995
- 4 generations backK981274 Acromed Timx Plate Based Low Back SystemAcromed Corp. · 1998
- 3 generations backK010576 Monarch Spine SystemDepuyacromed · 2001
- 2 generations backK024348 Monarch Spine SystemDepuyacromed · 2003
- 1 generation backK073126 Expedium Spine SystemDepuy Spine, Inc. · 2007
- This deviceK082195 Modifications to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 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
- Descendant · 3 generations on · 225 of its ownK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- Descendant · 4 generations on · 172 of its ownK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- Descendant · 5 generations on · 158 of its ownK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015
Showing 5 of 269 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 269 · See all- K092473Expedium Spine SystemDepuy Spine, Inc. · 2009 · cites it directly263descendants
- K101070Expedium Spine SystemMedos International SARL · 2010 · 2 generations on260descendants
- K122226Revere Stabilization SystemGlobus Medical, Inc. · 2012 · 3 generations on225descendants
- K124058Creo Stabilization SystemGlobus Medical, Inc. · 2013 · 4 generations on172descendants
- K143633CREO Stabilization SystemGlobus Medical, Inc. · 2015 · 5 generations on158descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944736 | VSP (Variable Screw Placement) | Acromed Corp. | 1995 | — |
| −4 | K981274 | Acromed Timx Plate Based Low Back System | Acromed Corp. | 1998 | — |
| −3 | K010576 | Monarch Spine System | Depuyacromed | 2001 | — |
| −2 | K024348 | Monarch Spine System | Depuyacromed | 2003 | — |
| −1 | K073126 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| 0 (this device) | K082195 | Modifications to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| +1 | 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 | — |
| +4 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| +5 | K143633 | CREO Stabilization System | Globus Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 9 | 0 |
| 2016 | 6 | 0 |
| 2017 | 6 | 0 |
| 2018 | 14 | 0 |
| 2019 | 14 | 0 |
| 2020 | 20 | 0 |
| 2021 | 15 | 1 |
| 2022 | 24 | 0 |
| 2023 | 35 | 0 |
| 2024 | 42 | 0 |
| 2025 | 36 | 0 |
| 2026 | 31 | 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? (2)
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 |
|---|---|---|---|
| * | K073126 | Expedium Spine SystemSummary page 1…l Number: 87 Product Code(s): NKB, KWQ, KWP, MNH, MNI Proprietary Name: EXPEDIUM Spine System Predicate Devices: EXPEDIUMTM Spine System (K073126) MOSS ® Miami Spine System (KO0 1182) Device Description: The subject EXPEDIUM Spine System… | 2007 |
| * | K011182 | Modified Moss Miami 4.35MM Diameter Polyaxial Screws Our reading of the summary gave K001182, FDA’s number for Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1 (Microlife Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “MOSS Miami Spine System”. | 2001 |
What descends from it? (269)
See all 2692 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 3.0 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K092473 (Depuy Spine, Inc., 2009) has gone furthest, with 263 descendants of its own.
- 6 other devices also cite its predicate K073126.
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 EXPEDIUMTM 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 EXPEDIUMTM 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/K082195 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082195: Modifications to Expedium Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082195
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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