510(k) · Cleared
ClearedMoss 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 18, 1997 after a 256-day review. The FDA summary names its predicate without a number. 1 of the 906 devices in its family, counting itself, has a Class I recall. 905 later devices descend from it.
- Decided
- Mar 18, 1997
- Review
- 256 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
905 later devices descend from it, 9 citing it directly. 1 of the 906 devices in this family, counting this one, has a Class I recall.
- This deviceK962628 Moss Miami Spinal SystemDepuy, Inc. · 1997
- Descendant · cites it directly · 889 of its ownK053115 Xia Spinal SystemStryker Spine · 2005
- Descendant · cites it directly · 742 of its ownK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- Descendant · 2 generations on · 735 of its ownK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- Descendant · 2 generations on · 734 of its ownK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- Descendant · 3 generations on · 710 of its ownK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
Showing 5 of 905 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 905 · See all- K053115Xia Spinal SystemStryker Spine · 2005 · cites it directly889descendants
- K050461Xia 4.5 Spinal SystemStryker Spine · 2005 · cites it directly742descendants
- K052761Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005 · 2 generations on735descendants
- K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · 2 generations on734descendants
- K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006 · 3 generations on710descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962628 | Moss Miami Spinal System | Depuy, Inc. | 1997 | — |
| +1 | K053115 | Xia Spinal System | Stryker Spine | 2005 | — |
| +1 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| +2 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| +2 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| +3 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 10 | 0 |
| 2007 | 10 | 0 |
| 2008 | 12 | 0 |
| 2009 | 20 | 0 |
| 2010 | 16 | 0 |
| 2011 | 18 | 0 |
| 2012 | 37 | 0 |
| 2013 | 36 | 0 |
| 2014 | 33 | 0 |
| 2015 | 42 | 0 |
| 2016 | 41 | 0 |
| 2017 | 58 | 0 |
| 2018 | 58 | 0 |
| 2019 | 53 | 0 |
| 2020 | 54 | 0 |
| 2021 | 44 | 1 |
| 2022 | 61 | 0 |
| 2023 | 88 | 0 |
| 2024 | 73 | 0 |
| 2025 | 70 | 0 |
| 2026 | 68 | 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? (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 |
|---|---|---|---|
| * | — | DePuy Motech MOSS Spinal System Named without a submission number | |
| * | — | DePuy Motech MOSS Miami Spinal Sytem, Pedicle Fixation Named without a submission number | |
| * | — | DePuy Motech MOSS Spinal System, Pedicle Fixation Named without a submission number |
What descends from it? (905)
See all 9059 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053115 | Xia Spinal System | 2005 | 889 |
| K050461 | Xia 4.5 Spinal System | 2005 | 742 |
| K090230 | Expedium Spine System | 2009 | 462 |
| K090648 | Viper 2 System | 2009 | 337 |
| K060748 | Modification to Xia 4.5 Spinal System | 2006 | 134 |
| K072022 | Valeo Pedicle Screw Spinal System | 2007 | 100 |
| K112684 | Mont Blanc Pedicle Screw Systems | 2012 | 5 |
| K080241 | DDS Stabilization System | 2008 | 5 |
| K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated… | 2019 | 0 |
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?
- Of its descendants, K053115 (Stryker Spine, 2005) has gone furthest, with 889 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?
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 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/K962628 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962628: Moss Miami Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962628
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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