510(k) Report

510(k) · Cleared

Cleared

Depuy Motech Moss Miami Spinal System

K980447510(k) TraditionalCleared Apr 14, 199868-day reviewClass II21 CFR 888.3070

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

DePuy Orthopaedics, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Apr 14, 1998 after a 68-day review. The FDA summary names its predicate without a number. 381 later devices descend from it.

Decided
Apr 14, 1998
Review
68 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
0

381 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2002: 6 descendants cleared2007: 3 descendants cleared1998: 2 descendants cleared2019: 19 descendants cleared2006: 3 descendants cleared2004: 6 descendants cleared2003: 4 descendants cleared2008: 7 descendants cleared2014: 10 descendants cleared2012: 11 descendants cleared2016: 18 descendants cleared2013: 13 descendants cleared2009: 3 descendants cleared2015: 15 descendants cleared2000: 1 descendant cleared1999: 2 descendants cleared2011: 4 descendants cleared2017: 27 descendants cleared2010: 4 descendants cleared2021: 18 descendants cleared2020: 26 descendants cleared2024: 35 descendants cleared2018: 19 descendants cleared2005: 1 descendant cleared2001: 1 descendant cleared2025: 36 descendants cleared2023: 36 descendants cleared2022: 25 descendants cleared2026: 26 descendants cleared1995200020052010201520202025
  1. This deviceK980447 Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc. · 1998
  2. Descendant · cites it directly · 305 of its ownK020674 Blackstone Spinal Fixation System 4.5MM Multi-Axial ScrewBlackstone Medical, Inc. · 2002
  3. Descendant · cites it directly · 304 of its ownK013558 Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc. · 2002
  4. Descendant · 2 generations on · 302 of its ownK022605 Blackstone Spinal Fixation System Staple & WasherBlackstone Medical, Inc. · 2002
  5. Descendant · cites it directly · 300 of its ownK023498 Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2002
  6. Descendant · 2 generations on · 300 of its ownK022399 Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc. · 2002

Showing 5 of 381 descendants. See all descendants

Descendants cleared per year

1998: 21999: 22000: 12001: 12002: 62003: 42004: 62005: 12006: 32007: 32008: 72009: 32010: 42011: 42012: 112013: 132014: 102015: 152016: 182017: 272018: 192019: 192020: 262021: 182022: 252023: 362024: 352025: 362026: 26
1998high 36 (2023) · low 1 (2000)2026

Most influential descendants

Showing 5 of 381 · See all
  • K020674Blackstone Spinal Fixation System 4.5MM Multi-Axial ScrewBlackstone Medical, Inc. · 2002 · cites it directly305descendants
  • K013558Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc. · 2002 · cites it directly304descendants
  • K022605Blackstone Spinal Fixation System Staple & WasherBlackstone Medical, Inc. · 2002 · 2 generations on302descendants
  • K023498Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2002 · cites it directly300descendants
  • K022399Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc. · 2002 · 2 generations on300descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K980447Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc.1998—
+1K020674Blackstone Spinal Fixation System 4.5MM Multi-Axial ScrewBlackstone Medical, Inc.2002—
+1K013558Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc.2002—
+2K022605Blackstone Spinal Fixation System Staple & WasherBlackstone Medical, Inc.2002—
+1K023498Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc.2002—
+2K022399Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199920
200010
200110
200260
200340
200460
200510
200630
200730
200870
200930
201040
201140
2012110
2013130
2014100
2015150
2016180
2017270
2018190
2019190
2020260
2021180
2022250
2023360
2024350
2025360
2026260
FIG. 1 — Lineage of K980447, 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 MNH? 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? (5)

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 MOSS Miami Spinal System, 4mm rod
Named without a submission number
—
*—Sofamor Danek TSRH Spinal System
Named without a submission number
—

What descends from it? (381)

See all 381

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

NumberDeviceApplicantDecidedDescendants
K020674Blackstone Spinal Fixation System 4.5MM Multi-Axial ScrewBlackstone Medical, Inc.2002305
K013558Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc.2002304
K023498Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc.2002300
K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc.1998251
K980484Aesculap Spine System EvolutionAesculap, Inc.1998251
K062785LTD Polyaxial Fixation SystemUs Spine200641
K071438PSS SystemSpinal USA200739
K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190

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, K020674 (Blackstone Medical, Inc., 2002) has gone furthest, with 305 descendants of its own.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
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 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 (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 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 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 MNH

The MNH category page

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https://510kreport.com/device/K980447 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980447: 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/K980447

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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