510(k) Report

510(k) · Cleared

Cleared

Moss Miami Spinal System Pin Nut

K023804510(k) SpecialCleared Jan 23, 200370-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

Depuyacromed · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Jan 23, 2003 as substantially equivalent to K010742 (Depuyacromed, 2001) after a 70-day review. Its family tree reaches back 1 generation to 2001. 1 of the 267 devices in its family, counting itself, has a Class I recall. 265 later devices descend from it.

Decided
Jan 23, 2003
Review
70 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K010742 (2001). 265 later devices descend from it, 3 citing it directly. 1 of the 267 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2009: 1 descendant cleared2019: 15 descendants cleared2011: 1 descendant cleared2010: 1 descendant cleared2017: 6 descendants cleared2013: 5 descendants cleared2018: 14 descendants cleared2012: 1 descendant cleared2014: 6 descendants cleared2023: 35 descendants cleared2021: 15 descendants cleared, 1 with a Class I recall12015: 9 descendants cleared2024: 41 descendants cleared2025: 36 descendants cleared2026: 31 descendants cleared2020: 19 descendants cleared2016: 5 descendants cleared2022: 24 descendants clearedK010742 · Moss Miami 5.5MM Titanium Pin Nut · Depuyacromed · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 5 descendants4 generations forward: 17 descendants5 generations forward: 43 descendants6 generations forward: 67 descendants, 1 with a Class I recall17 generations forward: 47 descendants8 generations forward: 32 descendants9 generations forward: 22 descendants10 generations forward: 19 descendants11 generations forward: 8 descendants K010742 · Moss Miami 5.5MM Titanium Pin Nut · Depuyacromed · 20010+5+10
  1. Root · 1 generation backK010742 Moss Miami 5.5MM Titanium Pin NutDepuyacromed · 2001
  2. This deviceK023804 Moss Miami Spinal System Pin NutDepuyacromed · 2003
  3. Descendant · cites it directly · 263 of its ownK092473 Expedium Spine SystemDepuy Spine, Inc. · 2009
  4. Descendant · 2 generations on · 260 of its ownK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
  5. Descendant · 3 generations on · 225 of its ownK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
  6. Descendant · 4 generations on · 172 of its ownK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
  7. Descendant · 5 generations on · 158 of its ownK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015

Showing 5 of 265 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 12012: 12013: 52014: 62015: 92016: 52017: 62018: 142019: 152020: 192021: 152022: 242023: 352024: 412025: 362026: 31
2009high 41 (2024) · low 1 (2009)2026

Class I recalls in this family

  • K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 265 · See all
  • K092473Expedium Spine SystemDepuy Spine, Inc. · 2009 · cites it directly263descendants
  • K101070Expedium Spine SystemMedos International SARL · 2010 · 2 generations on260descendants
  • K122226Revere Stabilization SystemGlobus Medical, Inc. · 2012 · 3 generations on225descendants
  • K124058Creo Stabilization SystemGlobus Medical, Inc. · 2013 · 4 generations on172descendants
  • K143633CREO Stabilization SystemGlobus Medical, Inc. · 2015 · 5 generations on158descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K010742Moss Miami 5.5MM Titanium Pin NutDepuyacromed2001—
0 (this device)K023804Moss Miami Spinal System Pin NutDepuyacromed2003—
+1K092473Expedium Spine SystemDepuy Spine, Inc.2009—
+2K101070Expedium Spine SystemMedos International SARL20101
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201110
201210
201350
201460
201590
201650
201760
2018140
2019150
2020190
2021151
2022240
2023350
2024410
2025360
2026310
FIG. 1 — Lineage of K023804, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

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? (1)

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
*K010742Moss Miami 5.5MM Titanium Pin NutDepuyacromed2001—

Also cleared against K010742: 2 other devices →

What descends from it? (265)

See all 265

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

NumberDeviceApplicantDecidedDescendants
K092473Expedium Spine SystemDepuy Spine, Inc.2009263
K110551Expedium Spine SystemJohnson & Johnson20111
K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190

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?

  • Its one ancestor has no recall.
  • Of its descendants, K092473 (Depuy Spine, Inc., 2009) has gone furthest, with 263 descendants of its own.
  • 2 other devices also cite its predicate K010742.

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?

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 K010742

2 other devices cite the same predicate.

  • K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System…Medos International SARL · 2019
  • K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC · 20071 recall

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
  • K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
  • K030249Surgical Titanium Mesh SystemDepuyacromed · 2003

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K023804 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023804: Moss Miami Spinal System Pin Nut.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023804

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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