510(k) · Cleared
ClearedMoss Miami 6.35MM Polyaxial Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuyacromed · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Sep 23, 1999 as substantially equivalent to K983583 (Depuy, Inc., 1998) and 3 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1996. 547 later devices descend from it.
- Decided
- Sep 23, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K955348 (1996). 4 ancestors in all, the oldest K933881 (1994). 547 later devices descend from it, 22 citing it directly.
- Root · 2 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- 1 generation backK964024 Depuy Motech Titanium Moss Miami Spinal SystemDepuy, Inc. · 1997
- This deviceK992168 Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 1999
- Descendant · cites it directly · 410 of its ownK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
- Descendant · cites it directly · 294 of its ownK022623 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed · 2002
- Descendant · 2 generations on · 180 of its ownK071890 Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 170 of its ownK093077 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009
- Descendant · 3 generations on · 168 of its ownK100685 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010
Showing 5 of 547 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 547 · See all- K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003 · cites it directly410descendants
- K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed · 2002 · cites it directly294descendants
- K071890Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2007 · 2 generations on180descendants
- K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009 · 3 generations on170descendants
- K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010 · 3 generations on168descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| −1 | K964024 | Depuy Motech Titanium Moss Miami Spinal System | Depuy, Inc. | 1997 | — |
| 0 (this device) | K992168 | Moss Miami 6.35MM Polyaxial Screw | Depuyacromed | 1999 | — |
| +1 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
| +1 | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) | Depuyacromed | 2002 | — |
| +2 | K071890 | Zodiac 4.0 Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2007 | 1 |
| +3 | K093077 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2009 | — |
| +3 | K100685 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 11 | 0 |
| 2008 | 10 | 0 |
| 2009 | 10 | 0 |
| 2010 | 10 | 0 |
| 2011 | 10 | 0 |
| 2012 | 21 | 0 |
| 2013 | 26 | 0 |
| 2014 | 27 | 0 |
| 2015 | 28 | 0 |
| 2016 | 29 | 0 |
| 2017 | 27 | 0 |
| 2018 | 33 | 0 |
| 2019 | 24 | 0 |
| 2020 | 32 | 0 |
| 2021 | 26 | 0 |
| 2022 | 35 | 0 |
| 2023 | 46 | 0 |
| 2024 | 45 | 0 |
| 2025 | 49 | 0 |
| 2026 | 36 | 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 KWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K983583 | Depuy Acromed Moss and Moss Miami Spinal SystemsSummary page 1…l screws is based on an equivalence in intended use, materials, design, and relative indications and contraindications to the existing Moss Miami Polyaxial Screw System (K983583, K953882, KS50697 and K933881 (stainless steel) and K983583, K964024, K955348 (titanium alloy). 2 _/@ DEPARTMENT… | 1998 |
| Kept off the family tree | K953882 | Moss Miami Polyaxial Screw System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…is based on an equivalence in intended use, materials, design, and relative indications and contraindications to the existing Moss Miami Polyaxial Screw System (K983583, K953882, KS50697 and K933881 (stainless steel) and K983583, K964024, K955348 (titanium alloy). 2 _/@ DEPARTMENT OF HEALTH… | |
| Kept off the family tree | K950697 | FDA’s K950697 is Depuy Motech Moss Miami Spinal System - Pedicle Fixation Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1995 |
| * | K933881 | Depuy Motech Moss-Miami Spinal SystemSummary page 1…lence in intended use, materials, design, and relative indications and contraindications to the existing Moss Miami Polyaxial Screw System (K983583, K953882, KS50697 and K933881 (stainless steel) and K983583, K964024, K955348 (titanium alloy). 2 _/@ DEPARTMENT OF HEALTH & HUMAN SERVICES Pub… | 1994 |
| * | K964024 | Depuy Motech Titanium Moss Miami Spinal SystemSummary page 1…n, and relative indications and contraindications to the existing Moss Miami Polyaxial Screw System (K983583, K953882, KS50697 and K933881 (stainless steel) and K983583, K964024, K955348 (titanium alloy). 2 _/@ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Admin… | 1997 |
| * | K955348 | Titanium Moss Miami Spinal SystemSummary page 1…lative indications and contraindications to the existing Moss Miami Polyaxial Screw System (K983583, K953882, KS50697 and K933881 (stainless steel) and K983583, K964024, K955348 (titanium alloy). 2 _/@ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration… | 1996 |
What descends from it? (547)
See all 54722 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | 2003 | 410 |
| K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) | 2002 | 294 |
| K101278 | Inertia Pedicle Screw System | 2010 | 111 |
| K013444 | Isobar Spinal System | 2001 | 94 |
| K051942 | Malibu Spinal System | 2005 | 81 |
| K051663 | Malibu Spinal System | 2005 | 81 |
| K061342 | Malibu Spinal System | 2006 | 80 |
| K100377 | Diamondback Spinal System | 2010 | 29 |
| K102853 | Flamenco Spinal Fixation System | 2011 | 22 |
| K123717 | Ucentum | 2013 | 17 |
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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K030383 (Depuyacromed, 2003) has gone furthest, with 410 descendants of its own.
- 25 other devices also cite its predicate K983583.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
When used as a posterior, noncervical hook, and/or sacralfiliac 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, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by patient history…
Read the full statement (181 words)
When used as a posterior, noncervical hook, and/or sacralfiliac 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, spondylolisthesis, 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 mature 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 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 pedicie screw fixation are L3 ~S1), and for whom the device system is intended to be removed after solid fusion is attained.
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/K992168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992168: Moss Miami 6.35MM Polyaxial Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992168
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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