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. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Nov 2, 2006 as substantially equivalent to K051024 (Depuy Spine, Inc., 2005) and 7 other predicates after a 94-day review. Its family tree reaches back 8 generations to 1985. 1 of the 523 devices in its family, counting itself, has a Class I recall. 490 later devices descend from it.
- Decided
- Nov 2, 2006
- Review
- 94 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 8 generations to K853033 (1985). 32 ancestors in all. 490 later devices descend from it, 19 citing it directly. 1 of the 523 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 7 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 6 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 5 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 4 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 3 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 2 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 1 generation backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- This deviceK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- Descendant · cites it directly · 424 of its ownK063156 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
Showing 5 of 490 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 490 · See all- K063156Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · cites it directly424descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −7 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −6 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −5 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −4 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −3 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −2 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −1 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| 0 (this device) | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 15 | 0 |
| 2013 | 20 | 0 |
| 2014 | 19 | 0 |
| 2015 | 24 | 0 |
| 2016 | 18 | 0 |
| 2017 | 27 | 0 |
| 2018 | 33 | 0 |
| 2019 | 27 | 0 |
| 2020 | 30 | 0 |
| 2021 | 26 | 1 |
| 2022 | 35 | 0 |
| 2023 | 52 | 0 |
| 2024 | 52 | 0 |
| 2025 | 47 | 0 |
| 2026 | 41 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (8)
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 SystemSummary page 1…dicle Fixation, Spinal Intervertebral Body Fixation PROPRIETARY NAME: EXPEDIUM Spine System PREDICATE DEVICES: EXPEDIUM Spine System (K051024), EXPEDIUM 5.5mm Commercially Pure Titanium (K052131), EXPEDIUMT M Spine System… | 2005 |
| * | K052131 | Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsSummary page 1…RIETARY NAME: EXPEDIUM Spine System PREDICATE DEVICES: EXPEDIUM Spine System (K051024), EXPEDIUM 5.5mm Commercially Pure Titanium (K052131), EXPEDIUMT M Spine System (K041119) and EXPEDIUM TM Spine System cleared as Me… | 2005 |
| * | K041119 | Expedium Spine SystemSummary page 1…: EXPEDIUM Spine System (K051024), EXPEDIUM 5.5mm Commercially Pure Titanium (K052131), EXPEDIUMT M Spine System (K041119) and EXPEDIUM TM Spine System cleared as Merlin Spine System (K033901), MONARCH… | 2004 |
| * | K033901 | Merlin Spine SystemSummary page 1…EXPEDIUMT M Spine System (K041119) and EXPEDIUM TM Spine System cleared as Merlin Spine System (K033901), MONARCH® Spine System (K021148, K010576), and MOUTAINEER TM OCT Spine System… | 2004 |
| * | K021148 | Monarch Spine System Commercially Pure Titanium Spinal RodSummary page 1…and EXPEDIUM TM Spine System cleared as Merlin Spine System (K033901), MONARCH® Spine System (K021148, K010576), and MOUTAINEER TM OCT Spine System (K041203) and ISOLA® Spine System… | 2002 |
| * | K010576 | Monarch Spine SystemSummary page 1…EXPEDIUM TM Spine System cleared as Merlin Spine System (K033901), MONARCH® Spine System (K021148, K010576), and MOUTAINEER TM OCT Spine System (K041203) and ISOLA® Spine System (K944756… | 2001 |
| * | K041203 | Summit Oct Spinal SystemSummary page 1…System (K033901), MONARCH® Spine System (K021148, K010576), and MOUTAINEER TM OCT Spine System (K041203) and ISOLA® Spine System (K944756). DEVICE DESCRIPTION: EXPEDIUM Spine System components are desi… | 2004 |
| * | K944756 | Isola Open and Closed ScrewsSummary page 1…stem (K021148, K010576), and MOUTAINEER TM OCT Spine System (K041203) and ISOLA® Spine System (K944756). DEVICE DESCRIPTION: EXPEDIUM Spine System components are designed to accept a 6.35mm rod and ar… | 1995 |
What descends from it? (490)
See all 49019 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063156 | Modification to Expedium Spine System | 2006 | 424 |
| K063741 | Expedium Spine System | 2007 | 398 |
| K080313 | Modification to Expedium Spine System | 2008 | 397 |
| K063772 | Expedium Spine System | 2007 | 264 |
| K101070 | Expedium Spine System | 2010 | 260 |
| K070387 | Expedium Spine System | 2007 | 248 |
| K102249 | Expedium Spine System | 2010 | 218 |
| K073562 | Modification to Viper Spine System | 2008 | 213 |
| K102204 | Choice Spine Starfire Pedicle Screw System | 2010 | 88 |
| K112920 | Range Spinal System (Mesa and Denali) | 2011 | 49 |
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 21 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- None of the 32 ancestors has a recall.
- Of its descendants, K063156 (Depuy Spine, Inc., 2006) has gone furthest, with 424 descendants of its own.
- 10 other devices also cite its predicate K051024.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062174: Modification 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/K062174
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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