510(k) Report

510(k) · Cleared

Cleared

Depuy Motech Moss-Miami Spinal System

K933881510(k) TraditionalCleared Jul 12, 1994336-day reviewClass II21 CFR 888.3050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Depuy, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Jul 12, 1994 after a 336-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 797 devices in its family, counting itself, has a Class I recall. 796 later devices descend from it.

Decided
Jul 12, 1994
Review
336 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

796 later devices descend from it, 15 citing it directly. 1 of the 797 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2012: 36 descendants cleared2009: 15 descendants cleared2008: 10 descendants cleared2011: 19 descendants cleared2019: 40 descendants cleared2016: 38 descendants cleared1998: 2 descendants cleared1999: 1 descendant cleared1997: 1 descendant cleared2007: 13 descendants cleared2010: 18 descendants cleared2014: 35 descendants cleared2013: 43 descendants cleared2022: 45 descendants cleared2015: 41 descendants cleared2017: 49 descendants cleared2024: 62 descendants cleared2018: 51 descendants cleared2003: 1 descendant cleared2025: 61 descendants cleared2002: 1 descendant cleared2005: 4 descendants cleared2004: 3 descendants cleared2001: 1 descendant cleared2006: 2 descendants cleared2020: 44 descendants cleared2023: 66 descendants cleared2021: 37 descendants cleared, 1 with a Class I recall12026: 57 descendants cleared1990200020102020
  1. This deviceK933881 Depuy Motech Moss-Miami Spinal SystemDepuy, Inc. · 1994
  2. Descendant · cites it directly · 547 of its ownK992168 Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 1999
  3. Descendant · cites it directly · 462 of its ownK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
  4. Descendant · cites it directly · 413 of its ownK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
  5. Descendant · 2 generations on · 410 of its ownK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
  6. Descendant · cites it directly · 337 of its ownK090648 Viper 2 SystemDepuy Spine, Inc. · 2009

Showing 5 of 796 descendants. See all descendants

Descendants cleared per year

1997: 11998: 21999: 12001: 12002: 12003: 12004: 32005: 42006: 22007: 132008: 102009: 152010: 182011: 192012: 362013: 432014: 352015: 412016: 382017: 492018: 512019: 402020: 442021: 372022: 452023: 662024: 622025: 612026: 57
1997high 66 (2023) · low 0 (2000)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 796 · See all
  • K992168Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 1999 · cites it directly547descendants
  • K090230Expedium Spine SystemDepuy Spine, Inc. · 2009 · cites it directly462descendants
  • K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998 · cites it directly413descendants
  • K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003 · 2 generations on410descendants
  • K090648Viper 2 SystemDepuy Spine, Inc. · 2009 · cites it directly337descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933881Depuy Motech Moss-Miami Spinal SystemDepuy, Inc.1994—
+1K992168Moss Miami 6.35MM Polyaxial ScrewDepuyacromed1999—
+1K090230Expedium Spine SystemDepuy Spine, Inc.2009—
+1K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc.1998—
+2K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed2003—
+1K090648Viper 2 SystemDepuy Spine, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199820
199910
200110
200210
200310
200430
200540
200620
2007130
2008100
2009150
2010180
2011190
2012360
2013430
2014350
2015410
2016380
2017490
2018510
2019400
2020440
2021371
2022450
2023660
2024620
2025610
2026570
FIG. 1 — Lineage of K933881, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (796)

See all 796

15 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K992168Moss Miami 6.35MM Polyaxial ScrewDepuyacromed1999547
K090230Expedium Spine SystemDepuy Spine, Inc.2009462
K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc.1998413
K090648Viper 2 SystemDepuy Spine, Inc.2009337
K070300Expedium SFX Cross Connector SystemDepuy Spine, Inc.200731
K072116Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions200824
K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098
K101112Reliance Spinal Screw SystemReliance Medical Systems20107
K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125
K072866Issys LP Spinal Fixation SystemCustom Spine, Inc.20072

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, K992168 (Depuyacromed, 1999) has gone furthest, with 547 descendants of its own.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—
Cite this page

510(k) Report. “K933881: Depuy Motech 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/K933881

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026