510(k) · Cleared
ClearedDepuy Motech Titanium 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 Mar 26, 1997 as substantially equivalent to K955348 (Depuy, Inc., 1996) after a 170-day review. Its family tree reaches back 1 generation to 1996. 1 of the 702 devices in its family, counting itself, has a Class I recall. 700 later devices descend from it.
- Decided
- Mar 26, 1997
- Review
- 170 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955348 (1996). 700 later devices descend from it, 14 citing it directly. 1 of the 702 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- This deviceK964024 Depuy Motech Titanium Moss Miami Spinal SystemDepuy, Inc. · 1997
- Descendant · cites it directly · 547 of its ownK992168 Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 1999
- Descendant · cites it directly · 413 of its ownK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
- Descendant · 2 generations on · 410 of its ownK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
- Descendant · cites it directly · 304 of its ownK073126 Expedium Spine SystemDepuy Spine, Inc. · 2007
- Descendant · 2 generations on · 294 of its ownK022623 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed · 2002
Showing 5 of 700 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 700 · See all- K992168Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 1999 · cites it directly547descendants
- K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998 · cites it directly413descendants
- K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003 · 2 generations on410descendants
- K073126Expedium Spine SystemDepuy Spine, Inc. · 2007 · cites it directly304descendants
- K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed · 2002 · 2 generations on294descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| 0 (this device) | K964024 | Depuy Motech Titanium Moss Miami Spinal System | Depuy, Inc. | 1997 | — |
| +1 | K992168 | Moss Miami 6.35MM Polyaxial Screw | Depuyacromed | 1999 | — |
| +1 | K982511 | Depuy Motech Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| +2 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
| +1 | K073126 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| +2 | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) | Depuyacromed | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 13 | 0 |
| 2008 | 12 | 0 |
| 2009 | 12 | 0 |
| 2010 | 11 | 0 |
| 2011 | 15 | 0 |
| 2012 | 27 | 0 |
| 2013 | 34 | 0 |
| 2014 | 32 | 0 |
| 2015 | 35 | 0 |
| 2016 | 38 | 0 |
| 2017 | 35 | 0 |
| 2018 | 43 | 0 |
| 2019 | 32 | 0 |
| 2020 | 41 | 0 |
| 2021 | 37 | 1 |
| 2022 | 44 | 0 |
| 2023 | 57 | 0 |
| 2024 | 58 | 0 |
| 2025 | 59 | 0 |
| 2026 | 49 | 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? (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 |
|---|---|---|---|
| * | K955348 | Titanium Moss Miami Spinal SystemSummary page 1…ameter polyaxial screws, hooks, transverse connectors, axial connectors, washers and staple washers. Titanium components of the MOSS Miami Spinal System were cleared in K955348 for the intended uses listed above. The components that were cleared included 5.5mm longitudinal smooth rods, 6 and 7mm diameter… | 1996 |
| * | — | DePuy Motech MOSS Miami Spinal System - Anterior Use Named without a submission number | |
| † | K953915 | Moss Miami Spinal System (Anterior Use) | 1996 |
What descends from it? (700)
See all 70014 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992168 | Moss Miami 6.35MM Polyaxial Screw | 1999 | 547 |
| K982511 | Depuy Motech Moss Miami Spinal Systems | 1998 | 413 |
| K073126 | Expedium Spine System | 2007 | 304 |
| K062136 | Pass 2 Spinal System | 2006 | 146 |
| K072116 | Savannah Lumbar Percutaneous Stabilization System | 2008 | 24 |
| K161627 | PASS LP Spinal System | 2016 | 7 |
| K131785 | Pagoda Pedicle Screw System | 2013 | 6 |
| K072866 | Issys LP Spinal Fixation System | 2007 | 2 |
| K112493 | Pass LP Spinal System | 2011 | 1 |
| K111099 | Issys LP Spinal Fixation System | 2011 | 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 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 | — |
What is it indicated for?
The MOSS Miami Spinal System is intended for non-cervical use in the spine. When used with anterior screw fixation or posterior hook, non-pedicle screw fixation the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed back surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by…
Read the full statement (147 words)
The MOSS Miami Spinal System is intended for non-cervical use in the spine. When used with anterior screw fixation or posterior hook, non-pedicle screw fixation the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed back surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
When used with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw attachment are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964024: Depuy Motech 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/K964024
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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