510(k) Report

510(k) · Cleared

Cleared

5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)

K022623510(k) SpecialCleared Aug 27, 200220-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 Aug 27, 2002 as substantially equivalent to K983583 (Depuy, Inc., 1998) and 2 other predicates after a 20-day review. Its family tree reaches back 3 generations to 1996. 294 later devices descend from it.

Decided
Aug 27, 2002
Review
20 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K955348 (1996). 6 ancestors in all, the oldest K933881 (1994). 294 later devices descend from it, 29 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1998: 1 other ancestor1994: 1 other ancestor2012: 8 descendants cleared2025: 33 descendants cleared2009: 1 descendant cleared2013: 14 descendants cleared2011: 6 descendants cleared2008: 1 descendant cleared2019: 13 descendants cleared2014: 12 descendants cleared2010: 4 descendants cleared2007: 3 descendants cleared2017: 8 descendants cleared2015: 12 descendants cleared2016: 15 descendants cleared2024: 33 descendants cleared2022: 26 descendants cleared2018: 13 descendants cleared2023: 31 descendants cleared2020: 18 descendants cleared2021: 14 descendants cleared2026: 29 descendants clearedK955348 · Titanium Moss Miami Spinal System · Depuy, Inc. · 1996K964024 · Depuy Motech Titanium Moss Miami Spinal System · Depuy, Inc. · 1997K992168 · Moss Miami 6.35MM Polyaxial Screw · Depuyacromed · 19991990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation forward: 29 descendants2 generations forward: 29 descendants3 generations forward: 34 descendants4 generations forward: 31 descendants5 generations forward: 40 descendants6 generations forward: 45 descendants7 generations forward: 44 descendants8 generations forward: 29 descendants9 generations forward: 12 descendants10 generations forward: 1 descendant K992168 · Moss Miami 6.35MM Polyaxial Screw · Depuyacromed · 1999K964024 · Depuy Motech Titanium Moss Miami Spinal System · Depuy, Inc. · 1997K955348 · Titanium Moss Miami Spinal System · Depuy, Inc. · 19960+5+10
  1. Root · 3 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
  2. 2 generations backK964024 Depuy Motech Titanium Moss Miami Spinal SystemDepuy, Inc. · 1997
  3. 1 generation backK992168 Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 1999
  4. This deviceK022623 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed · 2002
  5. Descendant · cites it directly · 138 of its ownK120291 OP Spine SystemOrthoPediatrics Corp. · 2012
  6. Descendant · 2 generations on · 127 of its ownK121630 Range Spinal SystemK2m, Inc. · 2012
  7. Descendant · cites it directly · 111 of its ownK101278 Inertia Pedicle Screw SystemNexxt Spine, LLC · 2010
  8. Descendant · 2 generations on · 107 of its ownK132412 Inertia Mis Pedicle Screw SystemNexxt Spine, LLC · 2013
  9. Descendant · 2 generations on · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014

Showing 5 of 294 descendants. See all descendants

Descendants cleared per year

2007: 32008: 12009: 12010: 42011: 62012: 82013: 142014: 122015: 122016: 152017: 82018: 132019: 132020: 182021: 142022: 262023: 312024: 332025: 332026: 29
2007high 33 (2024) · low 1 (2008)2026

Most influential descendants

Showing 5 of 294 · See all
  • K120291OP Spine SystemOrthoPediatrics Corp. · 2012 · cites it directly138descendants
  • K121630Range Spinal SystemK2m, Inc. · 2012 · 2 generations on127descendants
  • K101278Inertia Pedicle Screw SystemNexxt Spine, LLC · 2010 · cites it directly111descendants
  • K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC · 2013 · 2 generations on107descendants
  • K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC · 2014 · 2 generations on106descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K955348Titanium Moss Miami Spinal SystemDepuy, Inc.1996—
−2K964024Depuy Motech Titanium Moss Miami Spinal SystemDepuy, Inc.1997—
−1K992168Moss Miami 6.35MM Polyaxial ScrewDepuyacromed1999—
0 (this device)K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed2002—
+1K120291OP Spine SystemOrthoPediatrics Corp.2012—
+2K121630Range Spinal SystemK2m, Inc.2012—
+1K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010—
+2K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013—
+2K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure…Nexxt Spine, LLC2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199810
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200730
200810
200910
201040
201160
201280
2013140
2014120
2015120
2016150
201780
2018130
2019130
2020180
2021140
2022260
2023310
2024330
2025330
2026290
FIG. 1 — Lineage of K022623, 1996–2026Source: 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
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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
*K983583Depuy Acromed Moss and Moss Miami Spinal Systems
Summary page 1
…PROPRIETARY NAME: 5.0mm Diameter Polyaxial Screws for the Moss Miami 6.35mm System PREDICATE DEVICES: Moss Miami Spinal System (K983583, K992168 & K002607) INTENDED USE: When used as a posterior, noncervical hook, and/or…
Depuy, Inc.1998—
*K992168Moss Miami 6.35MM Polyaxial Screw
Summary page 1
…RY NAME: 5.0mm Diameter Polyaxial Screws for the Moss Miami 6.35mm System PREDICATE DEVICES: Moss Miami Spinal System (K983583, K992168 & K002607) INTENDED USE: When used as a posterior, noncervical hook, and/or…
Depuyacromed1999—
*K002607Moss Miami 6.35MM Rod System Monoaxial Screws, Polyaxial Reduction Screws and Sacral…
Summary page 1
…axial Screws for the Moss Miami 6.35mm System PREDICATE DEVICES: Moss Miami Spinal System (K983583, K992168 & K002607) INTENDED USE: When used as a posterior, noncervical hook, and/or sacral/iliac screw fixat…
Depuyacromed2000—

Also cleared against K983583: 25 other devices →

What descends from it? (294)

See all 294

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

NumberDeviceApplicantDecidedDescendants
K120291OP Spine SystemOrthoPediatrics Corp.2012138
K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010111
K100377Diamondback Spinal SystemEminent Spine201029
K072116Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions200824
K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG201122
K123717UcentumUlrich GmbH & Co. KG201317
K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075
K161516G Surgical Marksman MIS SystemG Surgical, LLC20163
K120074Foundation Spinal SystemThe Skeletal Design Partnership, Ltd.20122
K113173Nanovis Spinal SystemNanovis, LLC20122

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 6 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K120291 (OrthoPediatrics Corp., 2012) has gone furthest, with 138 descendants of its own.
  • 25 other devices also cite its predicate K983583.

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 K983583

25 other devices cite the same predicate.

  • K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System…Medos International SARL · 2019
  • K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd. · 2017
  • K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A. · 2016
  • K160926F1 MPS Modular Pedicle Screw SystemDegen Medical · 2016
  • K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014
  • K133287Presson Spinal Fixation SystemNexus Spine, LLC · 2014

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/K022623 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022623

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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