510(k) · Cleared
ClearedDepuy Motech 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 13, 1997 after an 80-day review. The FDA summary names its predicate without a number. 182 later devices descend from it.
- Decided
- Mar 13, 1997
- Review
- 80 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
182 later devices descend from it, 2 citing it directly.
- This deviceK965145 Depuy Motech Moss Miami Spinal SystemDepuy, Inc. · 1997
- Descendant · cites it directly · 179 of its ownK062513 Apex Spine SystemSpinecraft, Inc. · 2006
- Descendant · 2 generations on · 178 of its ownK092825 Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc. · 2010
- Descendant · 2 generations on · 177 of its ownK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- Descendant · 2 generations on · 111 of its ownK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · 2 generations on · 103 of its ownK110906 Apex Spine SystemSpinecraft, LLC · 2011
Showing 5 of 182 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 182 · See all- K062513Apex Spine SystemSpinecraft, Inc. · 2006 · cites it directly179descendants
- K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc. · 2010 · 2 generations on178descendants
- K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010 · 2 generations on177descendants
- K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012 · 2 generations on111descendants
- K110906Apex Spine SystemSpinecraft, LLC · 2011 · 2 generations on103descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K965145 | Depuy Motech Moss Miami Spinal System | Depuy, Inc. | 1997 | — |
| +1 | K062513 | Apex Spine System | Spinecraft, Inc. | 2006 | — |
| +2 | K092825 | Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer | Spinecraft, Inc. | 2010 | — |
| +2 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| +2 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| +2 | K110906 | Apex Spine System | Spinecraft, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 10 | 0 |
| 2016 | 4 | 0 |
| 2017 | 10 | 0 |
| 2018 | 13 | 0 |
| 2019 | 9 | 0 |
| 2020 | 16 | 0 |
| 2021 | 9 | 0 |
| 2022 | 13 | 0 |
| 2023 | 20 | 0 |
| 2024 | 22 | 0 |
| 2025 | 19 | 0 |
| 2026 | 15 | 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.
Planning a device in KWP? 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? (4)
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 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 Use Named without a submission number | |
| * | — | MOSS Miami 5.0mm smooth rod Named without a submission number |
What descends from it? (182)
See all 1822 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K062513 (Spinecraft, Inc., 2006) has gone furthest, with 179 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, with either the existing smooth rods or the subject ratchet rods, 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.…
Read the full statement (158 words)
The MOSS Miami Spinal System, with either the existing smooth rods or the subject ratchet rods, 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/K965145 · printed Nov 5, 2026
Cite this page
510(k) Report. “K965145: Depuy Motech Moss Miami Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965145
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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