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 May 8, 2008 as substantially equivalent to K062174 (Depuy Spine, Inc., 2006) and 2 other predicates after a 92-day review. Its family tree reaches back 11 generations to 1985. 1 of the 433 devices in its family, counting itself, has a Class I recall. 397 later devices descend from it.
- Decided
- May 8, 2008
- Review
- 92 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K853033 (1985). 35 ancestors in all. 397 later devices descend from it, 7 citing it directly. 1 of the 433 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 7 generations between
- 3 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 1 generation backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- This deviceK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- Descendant · cites it directly · 260 of its ownK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- Descendant · 2 generations on · 225 of its ownK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- Descendant · cites it directly · 203 of its ownK111571 Viper SystemsJohnson & Johnson · 2011
- Descendant · 3 generations on · 172 of its ownK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- Descendant · cites it directly · 162 of its ownK101993 Viper System, Expedium SystemDepuy Spine, Inc. · 2010 · Recalled
Show all 11 generations
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 9 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 8 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 7 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 6 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 5 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 4 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 3 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 1 generation backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- This deviceK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
Showing 5 of 397 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 397 · See all- K101070Expedium Spine SystemMedos International SARL · 2010 · cites it directly260descendants
- K122226Revere Stabilization SystemGlobus Medical, Inc. · 2012 · 2 generations on225descendants
- K111571Viper SystemsJohnson & Johnson · 2011 · cites it directly203descendants
- K124058Creo Stabilization SystemGlobus Medical, Inc. · 2013 · 3 generations on172descendants
- K101993Viper System, Expedium SystemDepuy Spine, Inc. · 2010 · cites it directly162descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −10 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −9 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −8 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −7 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −6 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −5 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −4 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −3 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −2 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −1 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| 0 (this device) | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| +1 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| +2 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| +1 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| +3 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| +1 | K101993 | Viper System, Expedium System | Depuy Spine, Inc. | 2010 | 8 |
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 |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 10 | 0 |
| 2013 | 15 | 0 |
| 2014 | 12 | 0 |
| 2015 | 17 | 0 |
| 2016 | 13 | 0 |
| 2017 | 16 | 0 |
| 2018 | 28 | 0 |
| 2019 | 24 | 0 |
| 2020 | 24 | 0 |
| 2021 | 23 | 1 |
| 2022 | 31 | 0 |
| 2023 | 46 | 0 |
| 2024 | 50 | 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? (3)
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 |
|---|---|---|---|
| * | K062174 | Modification to Expedium Spine SystemSummary page 1…er: 87 Product Code(s): NKB, MNH, MNI, KWP Proprietary Name: EXPEDIUM TM Spine System Predicate Devices: EXPEDIUMTM 6.35mm Spine System (K062174, K063156, K063741) Device Description: The subject EXPEDIUMTM Spine System components are… | 2006 |
| * | K063156 | Modification to Expedium Spine SystemSummary page 1…KB, MNH, MNI, KWP Proprietary Name: EXPEDIUM TM Spine System Predicate Devices: EXPEDIUMTM 6.35mm Spine System (K062174, K063156, K063741) Device Description: The subject EXPEDIUMTM Spine System components are designed to a… | 2006 |
| * | K063741 | Expedium Spine SystemSummary page 1…MNI, KWP Proprietary Name: EXPEDIUM TM Spine System Predicate Devices: EXPEDIUMTM 6.35mm Spine System (K062174, K063156, K063741) Device Description: The subject EXPEDIUMTM Spine System components are designed to accept a 6… | 2007 |
What descends from it? (397)
See all 3977 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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- None of the 35 ancestors has a recall.
- Of its descendants, K101070 (Medos International SARL, 2010) has gone furthest, with 260 descendants of its own.
- 18 other devices also cite its predicate K062174.
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/K080313 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080313: Modification to Expedium Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080313
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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