510(k) · Cleared
ClearedModification 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 Nov 22, 2006 as substantially equivalent to K051024 (Depuy Spine, Inc., 2005) and 1 other predicate after a 36-day review. Its family tree reaches back 9 generations to 1985. 1 of the 458 devices in its family, counting itself, has a Class I recall. 424 later devices descend from it.
- Decided
- Nov 22, 2006
- Review
- 36 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K853033 (1985). 33 ancestors in all. 424 later devices descend from it, 11 citing it directly. 1 of the 458 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 5 generations between
- 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- This deviceK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- Descendant · cites it directly · 398 of its ownK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- Descendant · cites it directly · 397 of its ownK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- Descendant · cites it directly · 264 of its ownK063772 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 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
Show all 9 generations
- Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 7 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 6 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 5 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 4 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- This deviceK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
Showing 5 of 424 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 424 · See all- K063741Expedium Spine SystemDepuy Spine, Inc. · 2007 · cites it directly398descendants
- K080313Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008 · cites it directly397descendants
- K063772Expedium Spine SystemDepuy Spine, Inc. · 2007 · cites it directly264descendants
- K092473Expedium Spine SystemDepuy Spine, Inc. · 2009 · 2 generations on263descendants
- 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 |
|---|---|---|---|---|---|
| −9 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −8 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −7 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −6 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −5 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −4 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −3 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −2 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −1 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| 0 (this device) | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| +1 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| +1 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| +1 | K063772 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| +2 | 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 |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 11 | 0 |
| 2013 | 16 | 0 |
| 2014 | 12 | 0 |
| 2015 | 17 | 0 |
| 2016 | 14 | 0 |
| 2017 | 23 | 0 |
| 2018 | 30 | 0 |
| 2019 | 26 | 0 |
| 2020 | 29 | 0 |
| 2021 | 23 | 1 |
| 2022 | 31 | 0 |
| 2023 | 47 | 0 |
| 2024 | 51 | 0 |
| 2025 | 43 | 0 |
| 2026 | 40 | 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 |
|---|---|---|---|
| * | K051024 | Expedium Spine System | 2005 |
| * | K062174 | Modification to Expedium Spine System Cleared while this submission was under review Summary page 1…ary Name: EXPEDIUMTM Spine System Predicate Devices: EXPEDIUMTM 5.5mm Spine System (KO51024) EXPEDIUM TM 6.35mm Spine System (K062174) Device Description: The subject EXPEDIUMTM Spine System components are designed to accept a 6… | 2006 |
What descends from it? (424)
See all 42411 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063741 | Expedium Spine System | 2007 | 398 |
| K080313 | Modification to Expedium Spine System | 2008 | 397 |
| K063772 | Expedium Spine System | 2007 | 264 |
| K101993 | Viper System, Expedium System | 2010 | 162 |
| K081898 | Expedium Spine System | 2008 | 59 |
| K123352 | S4 Spinal System | 2012 | 51 |
| K130291 | S4 Spinal System | 2013 | 44 |
| K133369 | Tiger Spine System | 2014 | 29 |
| K110216 | Expedium System, Viper System | 2011 | 4 |
| K113396 | Depuy Pulse Thoracolumbar Screw System | 2012 | 1 |
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 21 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- None of the 33 ancestors has a recall.
- Of its descendants, K063741 (Depuy Spine, Inc., 2007) has gone furthest, with 398 descendants of its own.
- 10 other devices also cite its predicate K051024.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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/K063156 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063156: Modification 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/K063156
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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