510(k) Report

510(k) · Cleared

Cleared

Depuy Motech Moss Miami Spinal System

K982011510(k) TraditionalCleared Aug 6, 199859-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 Orthopaedics, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Aug 6, 1998 after a 59-day review. The FDA summary names its predicate without a number. 412 later devices descend from it.

Decided
Aug 6, 1998
Review
59 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

412 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2011: 3 descendants cleared2019: 19 descendants cleared2016: 20 descendants cleared2007: 6 descendants cleared2009: 9 descendants cleared2012: 11 descendants cleared2020: 23 descendants cleared2008: 9 descendants cleared2010: 6 descendants cleared2014: 19 descendants cleared2013: 18 descendants cleared2024: 39 descendants cleared2006: 1 descendant cleared2004: 1 descendant cleared2017: 23 descendants cleared2018: 28 descendants cleared2022: 27 descendants cleared2005: 2 descendants cleared2015: 22 descendants cleared2023: 41 descendants cleared2021: 19 descendants cleared2025: 37 descendants cleared2026: 28 descendants cleared1995200020052010201520202025
  1. This deviceK982011 Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc. · 1998
  2. Descendant · cites it directly · 410 of its ownK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
  3. Descendant · 2 generations on · 180 of its ownK071890 Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2007 · Recalled
  4. Descendant · 3 generations on · 170 of its ownK093077 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009
  5. Descendant · 3 generations on · 168 of its ownK100685 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010
  6. Descendant · 4 generations on · 150 of its ownK133221 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · Recalled

Showing 5 of 412 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 22006: 12007: 62008: 92009: 92010: 62011: 32012: 112013: 182014: 192015: 222016: 202017: 232018: 282019: 192020: 232021: 192022: 272023: 412024: 392025: 372026: 28
2003high 41 (2023) · low 1 (2003)2026

Most influential descendants

Showing 5 of 412 · See all
  • K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003 · cites it directly410descendants
  • 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
  • K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · 4 generations on150descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K982011Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc.1998—
+1K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed2003—
+2K071890Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20071
+3K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009—
+3K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010—
+4K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20142

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200520
200610
200760
200890
200990
201060
201130
2012110
2013180
2014190
2015220
2016200
2017230
2018280
2019190
2020230
2021190
2022270
2023410
2024390
2025370
2026280
FIG. 1 — Lineage of K982011, 1998–2026Source: 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), 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—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
—
*—DePuy Motech Titanium MOSS Miami Spinal System
Named without a submission number
—

What descends from it? (412)

See all 412

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

NumberDeviceApplicantDecidedDescendants
K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed2003410
K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161
K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190
K102406Pass Anterior Spinal SystemMedicrea Technologies20110

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, K030383 (Depuyacromed, 2003) has gone furthest, with 410 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—

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 tumcr, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by…

Read the full statement (148 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 tumcr, 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 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.

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

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Recent decisions in KWP

The KWP category page

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  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
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https://510kreport.com/device/K982011 · printed Nov 3, 2026

Cite this page

510(k) Report. “K982011: Depuy Motech Moss Miami Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K982011

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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