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 May 30, 2008 as substantially equivalent to K071495 (Depuy Spine, A Johnson & Johnson Company, 2007) and 3 other predicates after a 28-day review. Its family tree reaches back 4 generations to 1996. 44 later devices descend from it.
- Decided
- May 30, 2008
- Review
- 28 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K955348 (1996). 16 ancestors in all, the oldest K944736 (1995). 44 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- 3 generations backK062196 SFX Snap-Fit Cross ConnectorDepuy Spine, Inc. · 2006
- 2 generations backK071495 Expedium 4.5MM Spine SystemDepuy Spine, A Johnson & Johnson Company · 2007
- 1 generation backK073364 Expedium 4.5MM Spine SystemDepuy Spine, Inc. · 2008
- This deviceK081252 Expedium 4.5MM Spine SystemDepuy Spine, Inc. · 2008
- Descendant · cites it directly · 21 of its ownK150417 Astra Spine SystemSpinecraft, LLC · 2015
- Descendant · 2 generations on · 12 of its ownK211323 ASTRA Spine SystemSpinecraft, LLC · 2021
- Descendant · cites it directly · 9 of its ownK100757 Tilock Pedicle Screw SystemGenesys Spine · 2010 · Recalled
- Descendant · 2 generations on · 8 of its ownK223273 ASTRA Spine SystemSpinecraft, LLC · 2022
- Descendant · 2 generations on · 8 of its ownK103671 Genesys Spine Tilock SystemGenesys Spine · 2011
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K150417Astra Spine SystemSpinecraft, LLC · 2015 · cites it directly21descendants
- K211323ASTRA Spine SystemSpinecraft, LLC · 2021 · 2 generations on12descendants
- K100757Tilock Pedicle Screw SystemGenesys Spine · 2010 · cites it directly9descendants
- K223273ASTRA Spine SystemSpinecraft, LLC · 2022 · 2 generations on8descendants
- K103671Genesys Spine Tilock SystemGenesys Spine · 2011 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| −3 | K062196 | SFX Snap-Fit Cross Connector | Depuy Spine, Inc. | 2006 | — |
| −2 | K071495 | Expedium 4.5MM Spine System | Depuy Spine, A Johnson & Johnson Company | 2007 | — |
| −1 | K073364 | Expedium 4.5MM Spine System | Depuy Spine, Inc. | 2008 | — |
| 0 (this device) | K081252 | Expedium 4.5MM Spine System | Depuy Spine, Inc. | 2008 | — |
| +1 | K150417 | Astra Spine System | Spinecraft, LLC | 2015 | — |
| +2 | K211323 | ASTRA Spine System | Spinecraft, LLC | 2021 | — |
| +1 | K100757 | Tilock Pedicle Screw System | Genesys Spine | 2010 | 1 |
| +2 | K223273 | ASTRA Spine System | Spinecraft, LLC | 2022 | — |
| +2 | K103671 | Genesys Spine Tilock System | Genesys Spine | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 4 | 0 |
| 2001 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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? (4)
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…: 87 Product Code(s): NKB, MNH, MNI, KWP, KWQ Proprietary Name: EXPEDIUM Spine System Predicate Devices: EXPEDIUM 4.5mm Spine System (K071495, K073364) MONARCH® Spine System (K010576) ISOLA® Spine System (K964007)… | 2007 |
| * | K073364 | Expedium 4.5MM Spine SystemSummary page 1…Product Code(s): NKB, MNH, MNI, KWP, KWQ Proprietary Name: EXPEDIUM Spine System Predicate Devices: EXPEDIUM 4.5mm Spine System (K071495, K073364) MONARCH® Spine System (K010576) ISOLA® Spine System (K964007)… | 2008 |
| * | K010576 | Monarch Spine SystemSummary page 1…prietary Name: EXPEDIUM Spine System Predicate Devices: EXPEDIUM 4.5mm Spine System (K071495, K073364) MONARCH® Spine System (K010576) ISOLA® Spine System (K964007) Device Description: The subject EXPEDIUMTM Spine System compo… | 2001 |
| * | K964007 | Acromed Cable/Wire Pedicle ScrewSummary page 1…Devices: EXPEDIUM 4.5mm Spine System (K071495, K073364) MONARCH® Spine System (K010576) ISOLA® Spine System (K964007) Device Description: The subject EXPEDIUMTM Spine System components are designed to accept a 4… | 1996 |
What descends from it? (44)
See all 447 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150417 | Astra Spine System | 2015 | 21 |
| K100757 | Tilock Pedicle Screw System | 2010 | 9 |
| K081978 | Reliance Spinal Screw System | 2009 | 8 |
| K101112 | Reliance Spinal Screw System | 2010 | 7 |
| K110896 | Reliance Spinal Screw System | 2012 | 5 |
| K143683 | APEX-DL Spine System | 2015 | 3 |
| K180754 | C-Zero Pedicle Screw System, Freedom Pedicle Screw System | 2018 | 0 |
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 12 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K150417 (Spinecraft, LLC, 2015) has gone furthest, with 21 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/K081252 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081252: Expedium 4.5MM 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/K081252
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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