510(k) · Cleared
ClearedTitanium Moss Miami Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Feb 16, 1996 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 1,020 devices in its family, counting itself, has a Class I recall. 1,019 later devices descend from it.
- Decided
- Feb 16, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
1,019 later devices descend from it, 34 citing it directly. 1 of the 1,020 devices in this family, counting this one, has a Class I recall.
- This deviceK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- Descendant · cites it directly · 700 of its ownK964024 Depuy Motech Titanium Moss Miami Spinal SystemDepuy, Inc. · 1997
- Descendant · cites it directly · 596 of its ownK010576 Monarch Spine SystemDepuyacromed · 2001
- Descendant · 2 generations on · 578 of its ownK024348 Monarch Spine SystemDepuyacromed · 2003
- Descendant · cites it directly · 559 of its ownK062196 SFX Snap-Fit Cross ConnectorDepuy Spine, Inc. · 2006
- Descendant · cites it directly · 547 of its ownK992168 Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 1999
Showing 5 of 1,019 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 1,019 · See all- K964024Depuy Motech Titanium Moss Miami Spinal SystemDepuy, Inc. · 1997 · cites it directly700descendants
- K010576Monarch Spine SystemDepuyacromed · 2001 · cites it directly596descendants
- K024348Monarch Spine SystemDepuyacromed · 2003 · 2 generations on578descendants
- K062196SFX Snap-Fit Cross ConnectorDepuy Spine, Inc. · 2006 · cites it directly559descendants
- K992168Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 1999 · cites it directly547descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| +1 | K964024 | Depuy Motech Titanium Moss Miami Spinal System | Depuy, Inc. | 1997 | — |
| +1 | K010576 | Monarch Spine System | Depuyacromed | 2001 | — |
| +2 | K024348 | Monarch Spine System | Depuyacromed | 2003 | — |
| +1 | K062196 | SFX Snap-Fit Cross Connector | Depuy Spine, Inc. | 2006 | — |
| +1 | K992168 | Moss Miami 6.35MM Polyaxial Screw | Depuyacromed | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 9 | 0 |
| 2005 | 8 | 0 |
| 2006 | 9 | 0 |
| 2007 | 20 | 0 |
| 2008 | 20 | 0 |
| 2009 | 21 | 0 |
| 2010 | 25 | 0 |
| 2011 | 29 | 0 |
| 2012 | 50 | 0 |
| 2013 | 49 | 0 |
| 2014 | 41 | 0 |
| 2015 | 50 | 0 |
| 2016 | 52 | 0 |
| 2017 | 54 | 0 |
| 2018 | 60 | 0 |
| 2019 | 51 | 0 |
| 2020 | 52 | 0 |
| 2021 | 45 | 1 |
| 2022 | 60 | 0 |
| 2023 | 82 | 0 |
| 2024 | 74 | 0 |
| 2025 | 73 | 0 |
| 2026 | 68 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1,019)
See all 1,01934 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K964024 | Depuy Motech Titanium Moss Miami Spinal System | 1997 | 700 |
| K010576 | Monarch Spine System | 2001 | 596 |
| K062196 | SFX Snap-Fit Cross Connector | 2006 | 559 |
| K992168 | Moss Miami 6.35MM Polyaxial Screw | 1999 | 547 |
| K052131 | Expedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods | 2005 | 495 |
| K982511 | Depuy Motech Moss Miami Spinal Systems | 1998 | 413 |
| K041592 | Coral Spinal System | 2004 | 261 |
| K982914 | Aesculap Spine System Evolution: Additional Components | 1998 | 251 |
| K980484 | Aesculap Spine System Evolution | 1998 | 251 |
| K120696 | Tiger Spine System | 2012 | 41 |
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?
- Of its descendants, K964024 (Depuy, Inc., 1997) has gone furthest, with 700 descendants of its own.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K955348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955348: Titanium Moss Miami Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955348
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026