510(k) Report

510(k) · Cleared

Cleared

Depuy Motech Moss-Miami Spinal System

K972568510(k) TraditionalCleared Sep 19, 199771-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, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Sep 19, 1997 as substantially equivalent to K933881 (Depuy, Inc., 1994) after a 71-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.

Decided
Sep 19, 1997
Review
71 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K933881 (1994). 2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2019: 1 descendant clearedK933881 · Depuy Motech Moss-Miami Spinal System · Depuy, Inc. · 19941990200020102020
Descendants, by generation 1 generation forward: 2 descendants K933881 · Depuy Motech Moss-Miami Spinal System · Depuy, Inc. · 19940
  1. Root · 1 generation backK933881 Depuy Motech Moss-Miami Spinal SystemDepuy, Inc. · 1994
  2. This deviceK972568 Depuy Motech Moss-Miami Spinal SystemDepuy, Inc. · 1997
  3. Descendant · cites it directly · 0 of its ownK191212 CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System…Medos International SARL · 2019
  4. Descendant · cites it directly · 0 of its ownK974573 Depuy Motech Moss-Miami Spinal SystemDepuy, Inc. · 1998

Most influential descendants

Showing 2 of 2 · See all
  • K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL · 2019 · cites it directly0descendants
  • K974573Depuy Motech Moss-Miami Spinal SystemDepuy, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K933881Depuy Motech Moss-Miami Spinal SystemDepuy, Inc.1994—
0 (this device)K972568Depuy Motech Moss-Miami Spinal SystemDepuy, Inc.1997—
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM…Medos International SARL2019—
+1K974573Depuy Motech Moss-Miami Spinal SystemDepuy, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
201910
FIG. 1 — Lineage of K972568, 1994–2019Source: 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
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What was it cleared against? (3)

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
*K933881Depuy Motech Moss-Miami Spinal System
Summary page 2
…etween the sacral extender body and the longitudinal rod is the same mechanism as is used for the screws and hooks in the MOSS Miami system originally cleared for use in K933881. BASIS OF SUBSTANTIAL EQUIVALENCE: The MOSS Miami Sacral Extender is substantially equivalent to the MOSS Miami Smm longitudina…
Depuy, Inc.1994—
*—Harrington Rods
Named without a submission number
—
*—Acromed ISOLA Spinal System
Named without a submission number
—

Also cleared against K933881: 14 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190
K974573Depuy Motech Moss-Miami Spinal SystemDepuy, Inc.19980

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?

  • Its one ancestor has no recall.
  • Of its descendants, K191212 (Medos International SARL, 2019) has gone furthest, with 0 descendants of its own.
  • 14 other devices also cite its predicate K933881.

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 (147 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 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 attachment are 1.3 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.

Also cleared against K933881

14 other devices cite the same predicate.

  • K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System…Medos International SARL · 2019
  • K160926F1 MPS Modular Pedicle Screw SystemDegen Medical · 2016
  • K113361Securis Spinal FixationCumtom Spine · 2012
  • K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2012
  • K111099Issys LP Spinal Fixation SystemCustom Spine, Inc. · 20111 recall
  • K101112Reliance Spinal Screw SystemReliance Medical Systems · 2010

More from Depuy, Inc.

719 FDA decisions under this applicant name. See the company

  • P830055/S379ATTUNE Revision Knee SystemDepuy, Inc. · 2026
  • P830055/S377ATTUNE Rotating Platform (RP) Total Knee System, ATTUNE Revision Rotating Platform (RP) Total Knee System…Depuy, Inc. · 2026
  • P830055/S380LCS® Total Knee SystemDepuy, Inc. · 2026
  • P830055/S375LCS® Total Knee SystemDepuy, Inc. · 2026
  • P830055/S351Attune Revision Knee SystemDepuy, Inc. · 2026

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K972568 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972568: 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/K972568

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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