510(k) · Cleared
ClearedDepuy Acromed Moss and Moss Miami Spinal Systems
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 Dec 3, 1998 after a 51-day review. The FDA summary names its predicate without a number. 1 of the 966 devices in its family, counting itself, has a Class I recall. 965 later devices descend from it.
- Decided
- Dec 3, 1998
- Review
- 51 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
965 later devices descend from it, 26 citing it directly. 1 of the 966 devices in this family, counting this one, has a Class I recall.
- This deviceK983583 Depuy Acromed Moss and Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 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 · 547 of its ownK992168 Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 1999
- Descendant · 2 generations on · 496 of its ownK021148 Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed · 2002
- Descendant · 3 generations on · 495 of its ownK052131 Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005
Showing 5 of 965 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 965 · See all- K010576Monarch Spine SystemDepuyacromed · 2001 · cites it directly596descendants
- K024348Monarch Spine SystemDepuyacromed · 2003 · 2 generations on578descendants
- K992168Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 1999 · cites it directly547descendants
- K021148Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed · 2002 · 2 generations on496descendants
- K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005 · 3 generations on495descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983583 | Depuy Acromed Moss and Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| +1 | K010576 | Monarch Spine System | Depuyacromed | 2001 | — |
| +2 | K024348 | Monarch Spine System | Depuyacromed | 2003 | — |
| +1 | K992168 | Moss Miami 6.35MM Polyaxial Screw | Depuyacromed | 1999 | — |
| +2 | K021148 | Monarch Spine System Commercially Pure Titanium Spinal Rod | Depuyacromed | 2002 | — |
| +3 | K052131 | Expedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods | Depuy Spine, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 6 | 0 |
| 2007 | 16 | 0 |
| 2008 | 18 | 0 |
| 2009 | 18 | 0 |
| 2010 | 20 | 0 |
| 2011 | 22 | 0 |
| 2012 | 45 | 0 |
| 2013 | 44 | 0 |
| 2014 | 40 | 0 |
| 2015 | 46 | 0 |
| 2016 | 43 | 0 |
| 2017 | 54 | 0 |
| 2018 | 59 | 0 |
| 2019 | 50 | 0 |
| 2020 | 52 | 0 |
| 2021 | 45 | 1 |
| 2022 | 58 | 0 |
| 2023 | 86 | 0 |
| 2024 | 74 | 0 |
| 2025 | 70 | 0 |
| 2026 | 66 | 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? (9)
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 |
|---|---|---|---|
| * | — | DePuy Motech MOSS Miami Spinal System (for posterior use) Named without a submission number | |
| * | — | DePuy Motech MOSS Miami Spinal System - Pedicle Fixation Named without a submission number | |
| * | — | DePuy Motech MOSS Miami Spinal System - anterior indications Named without a submission number | |
| * | — | DePuy Motech MOSS Miami 4.0 mm Rod Spinal Subsystem Named without a submission number | |
| * | — | DePuy Motech Universal Spinal System and Transverse Rod Stabilizer Named without a submission number | |
| * | — | Biedermann Motech MOSS Miami Spinal System, 6.0mm Rod Subsystem Named without a submission number | |
| * | — | DePuy Motech Titanium MOSS Miami Spinal System Named without a submission number | |
| * | — | DePuy Motech MOSS Miami Spinal System Ratchet Rods Named without a submission number | |
| * | — | DePuy Motech MOSS Miami Titanium Sacral Extenders Named without a submission number |
What descends from it? (965)
See all 96526 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K010576 | Monarch Spine System | 2001 | 596 |
| K992168 | Moss Miami 6.35MM Polyaxial Screw | 1999 | 547 |
| K090230 | Expedium Spine System | 2009 | 462 |
| K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | 2003 | 410 |
| K994347 | Centaur Spinal System | 2000 | 343 |
| K090648 | Viper 2 System | 2009 | 337 |
| K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) | 2002 | 294 |
| K013296 | Moss Miami Spinal Systems | 2001 | 184 |
| K132049 | Thunderbolt and Lancer Pedicle Screw Systems | 2014 | 82 |
| K072116 | Savannah Lumbar Percutaneous Stabilization System | 2008 | 24 |
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, K010576 (Depuyacromed, 2001) has gone furthest, with 596 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 | — |
What is it indicated for?
When used as a posterior, noncervical screw fixation system or as an anterior, thoracic/lumbar screw fixation system, the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylol:sthesis, a previously failed fusion surgery or degenerative disc disease (i.e. discogenic: back pain with degeneration of the disc confirmed by patient history and radiographic studies).…
Read the full statement (182 words)
When used as a posterior, noncervical screw fixation system or as an anterior, thoracic/lumbar screw fixation system, the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylol:sthesis, a previously failed fusion surgery or degenerative disc disease (i.e. discogenic: back pain with degeneration of the disc confirmed by patient history and radiographic studies).
When used as a pedicle screw fixation system of the noncervical spine in skeletally matrue patients, the MOSS Miami Spinal System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The MOSS Miami Spinal System is also indicated for pedicle screw fixation in skeletally mature pazients with severe spondylolisthesis (Grades 3 and 4) at the L.5-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 fixation 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/K983583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983583: Depuy Acromed Moss and Moss Miami Spinal Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983583
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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