510(k) Report

510(k) · Cleared

Cleared

Modification to Moss Miami Spinal System Polyaxial Screws

K030383510(k) SpecialCleared Feb 26, 200321-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

Depuyacromed · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Feb 26, 2003 as substantially equivalent to K953915 (Depuy, Inc., 1996) and 6 other predicates after a 21-day review. Its family tree reaches back 3 generations to 1995. 410 later devices descend from it.

Decided
Feb 26, 2003
Review
21 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
7

Its longest line of descent runs back 3 generations to K951116 (1995). 15 ancestors in all, the oldest K933881 (1994). 410 later devices descend from it, 23 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1999: 1 other ancestor1998: 3 other ancestors1996: 3 other ancestors1997: 1 other ancestor1995: 2 other ancestors1994: 1 other ancestor2007: 6 descendants cleared2009: 9 descendants cleared2012: 11 descendants cleared2020: 23 descendants cleared2008: 9 descendants cleared2010: 6 descendants cleared2019: 19 descendants cleared2014: 19 descendants cleared2016: 20 descendants cleared2013: 18 descendants cleared2024: 39 descendants cleared2006: 1 descendant cleared2004: 1 descendant cleared2017: 23 descendants cleared2022: 27 descendants cleared2005: 2 descendants cleared2015: 22 descendants cleared2018: 28 descendants cleared2023: 41 descendants cleared2021: 19 descendants cleared2025: 37 descendants cleared2026: 28 descendants cleared2011: 2 descendants clearedK951116 · Acromed Pedicle Screw · Acromed Corp. · 1995K963639 · Acromed Pedicle Screw · Acromed Corp. · 1996K982511 · Depuy Motech Moss Miami Spinal Systems · Depuy, Inc. · 19981990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 6 other ancestors 1 generation forward: 23 descendants2 generations forward: 54 descendants3 generations forward: 65 descendants4 generations forward: 79 descendants5 generations forward: 63 descendants6 generations forward: 52 descendants7 generations forward: 47 descendants8 generations forward: 24 descendants9 generations forward: 2 descendants10 generations forward: 1 descendant K982511 · Depuy Motech Moss Miami Spinal Systems · Depuy, Inc. · 1998K963639 · Acromed Pedicle Screw · Acromed Corp. · 1996K951116 · Acromed Pedicle Screw · Acromed Corp. · 19950+5+10
  1. Root · 3 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
  2. 2 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
  3. 1 generation backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
  4. This deviceK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
  5. Descendant · cites it directly · 180 of its ownK071890 Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2007 · Recalled
  6. Descendant · 2 generations on · 170 of its ownK093077 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009
  7. Descendant · 2 generations on · 168 of its ownK100685 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010
  8. Descendant · 3 generations on · 150 of its ownK133221 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · Recalled
  9. Descendant · cites it directly · 138 of its ownK120291 OP Spine SystemOrthoPediatrics Corp. · 2012

Showing 5 of 410 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22006: 12007: 62008: 92009: 92010: 62011: 22012: 112013: 182014: 192015: 222016: 202017: 232018: 282019: 192020: 232021: 192022: 272023: 412024: 392025: 372026: 28
2004high 41 (2023) · low 1 (2004)2026

Most influential descendants

Showing 5 of 410 · See all
  • K071890Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2007 · cites it directly180descendants
  • K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009 · 2 generations on170descendants
  • K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010 · 2 generations on168descendants
  • K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · 3 generations on150descendants
  • K120291OP Spine SystemOrthoPediatrics Corp. · 2012 · cites it directly138descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K951116Acromed Pedicle ScrewAcromed Corp.1995—
−2K963639Acromed Pedicle ScrewAcromed Corp.1996—
−1K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc.1998—
0 (this device)K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed2003—
+1K071890Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20071
+2K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009—
+2K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010—
+3K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20142
+1K120291OP Spine SystemOrthoPediatrics Corp.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199520
199630
199710
199830
199910
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200610
200760
200890
200990
201060
201120
2012110
2013180
2014190
2015220
2016200
2017230
2018280
2019190
2020230
2021190
2022270
2023410
2024390
2025370
2026280
FIG. 1 — Lineage of K030383, 1995–2026Source: 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
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What was it cleared against? (7)

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
*K953915Moss Miami Spinal System (Anterior Use)
Summary page 1
…Orthosis, Spinal Pedicle Fixation PROPRIETARY NAME: Moss Miami Spinal System Polyaxial Screws PREDICATE DEVICES: Moss Miami Spinal System (K953915, K982320, K982511, K982011, K983583, K992168, KO11182) DEVICE DESCRIPTION: The Moss Miami Spinal Syste…
Depuy, Inc.1996—
*K982320Depuy Motech Moss Miami Spinal System
Summary page 1
…Orthosis, Spinal Pedicle Fixation PROPRIETARY NAME: Moss Miami Spinal System Polyaxial Screws PREDICATE DEVICES: Moss Miami Spinal System (K953915, K982320, K982511, K982011, K983583, K992168, KO11182) DEVICE DESCRIPTION: The Moss Miami Spinal System Polyaxi…
Depuy, Inc.1998—
*K982511Depuy Motech Moss Miami Spinal Systems
Summary page 1
…ion PROPRIETARY NAME: Moss Miami Spinal System Polyaxial Screws PREDICATE DEVICES: Moss Miami Spinal System (K953915, K982320, K982511, K982011, K983583, K992168, KO11182) DEVICE DESCRIPTION: The Moss Miami Spinal System Polyaxial Screws and P…
Depuy, Inc.1998—
*K982011Depuy Motech Moss Miami Spinal System
Summary page 1
…RIETARY NAME: Moss Miami Spinal System Polyaxial Screws PREDICATE DEVICES: Moss Miami Spinal System (K953915, K982320, K982511, K982011, K983583, K992168, KO11182) DEVICE DESCRIPTION: The Moss Miami Spinal System Polyaxial Screws and Polyaxial…
DePuy Orthopaedics, Inc.1998—
*K983583Depuy Acromed Moss and Moss Miami Spinal Systems
Summary page 1
…AME: Moss Miami Spinal System Polyaxial Screws PREDICATE DEVICES: Moss Miami Spinal System (K953915, K982320, K982511, K982011, K983583, K992168, KO11182) DEVICE DESCRIPTION: The Moss Miami Spinal System Polyaxial Screws and Polyaxial Reduction…
Depuy, Inc.1998—
*K992168Moss Miami 6.35MM Polyaxial Screw
Summary page 1
…Moss Miami Spinal System Polyaxial Screws PREDICATE DEVICES: Moss Miami Spinal System (K953915, K982320, K982511, K982011, K983583, K992168, KO11182) DEVICE DESCRIPTION: The Moss Miami Spinal System Polyaxial Screws and Polyaxial Reduction Screws a…
Depuyacromed1999—
*K011182Modified Moss Miami 4.35MM Diameter Polyaxial ScrewsDepuyacromed2001—

Also cleared against K953915: 7 other devices →

What descends from it? (410)

See all 410

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

NumberDeviceApplicantDecidedDescendants
K071890Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2007180
K120291OP Spine SystemOrthoPediatrics Corp.2012138
K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088
K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382
K033352Vertebron PSS Pedicle Screw SystemVertebron, Inc.200462
K070245Capsure Pedicle Screw SystemSpine Wave, Inc.200742
K082353Mercury Spinal SystemSpinal Elements, Inc.200911
K083230Mercury Spinal SystemSpinal Elements, Inc.200811
K141372Mercury Spinal SystemSpinal Elements, Inc.20149
K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098

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 8 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
  • None of the 15 ancestors has a recall.
  • Of its descendants, K071890 (Alphatec Spine, Inc., 2007) has gone furthest, with 180 descendants of its own.
  • 7 other devices also cite its predicate K953915.

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?

When used as a posterior, noncervical hook, and/or sacral/iliac 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 (184 words)

When used as a posterior, noncervical hook, and/or sacral/iliac 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 pedicle screw fixation are L3 - S1), and for whom the device system is intended to be removed after solid fusion is attained.

Indications for use as stated in the FDA summary.

Also cleared against K953915

7 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
  • K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL · 2012
  • K102701Viper Spine SystemDepuy Spine, Inc. · 2010
  • K092473Expedium Spine SystemDepuy Spine, Inc. · 2009
  • K012916Frontier Anterior Scoliosis SystemDepuy Acromed, Inc. · 2001

More from Depuyacromed

48 FDA decisions under this applicant name. See the company

  • K040197Eagle Anterior Cervial Plate SystemDepuyacromed · 2004
  • K031635Depuy Acromed VBR SystemDepuyacromed · 2003
  • K030833Depuy Acromed VBR SystemDepuyacromed · 2003
  • K030249Surgical Titanium Mesh SystemDepuyacromed · 2003
  • K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003

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/K030383 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030383: Modification to Moss Miami Spinal System Polyaxial Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030383

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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