510(k) Report

510(k) · Cleared

Cleared

Moss Miami 6.35MM Rod System Monoaxial Screws, Polyaxial Reduction Screws and Sacral Extenders

K002607510(k) SpecialCleared Sep 12, 200021-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 Sep 12, 2000 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 339 later devices descend from it.

Decided
Sep 12, 2000
Review
21 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

339 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2005: 2 descendants cleared2019: 15 descendants cleared2006: 1 descendant cleared2012: 10 descendants cleared2025: 41 descendants cleared2009: 1 descendant cleared2013: 14 descendants cleared2011: 6 descendants cleared2008: 1 descendant cleared2014: 12 descendants cleared2010: 4 descendants cleared2007: 4 descendants cleared2017: 9 descendants cleared2015: 14 descendants cleared2016: 17 descendants cleared2018: 16 descendants cleared2024: 36 descendants cleared2022: 29 descendants cleared2023: 33 descendants cleared2020: 20 descendants cleared2021: 18 descendants cleared2026: 35 descendants cleared200020052010201520202025
  1. This deviceK002607 Moss Miami 6.35MM Rod System Monoaxial Screws, Polyaxial Reduction…Depuyacromed · 2000
  2. Descendant · cites it directly · 294 of its ownK022623 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed · 2002
  3. Descendant · 2 generations on · 138 of its ownK120291 OP Spine SystemOrthoPediatrics Corp. · 2012
  4. Descendant · 3 generations on · 127 of its ownK121630 Range Spinal SystemK2m, Inc. · 2012
  5. Descendant · 2 generations on · 111 of its ownK101278 Inertia Pedicle Screw SystemNexxt Spine, LLC · 2010
  6. Descendant · 3 generations on · 107 of its ownK132412 Inertia Mis Pedicle Screw SystemNexxt Spine, LLC · 2013

Showing 5 of 339 descendants. See all descendants

Descendants cleared per year

2002: 12005: 22006: 12007: 42008: 12009: 12010: 42011: 62012: 102013: 142014: 122015: 142016: 172017: 92018: 162019: 152020: 202021: 182022: 292023: 332024: 362025: 412026: 35
2002high 41 (2025) · low 0 (2003)2026

Most influential descendants

Showing 5 of 339 · See all
  • K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed · 2002 · cites it directly294descendants
  • K120291OP Spine SystemOrthoPediatrics Corp. · 2012 · 2 generations on138descendants
  • K121630Range Spinal SystemK2m, Inc. · 2012 · 3 generations on127descendants
  • K101278Inertia Pedicle Screw SystemNexxt Spine, LLC · 2010 · 2 generations on111descendants
  • K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC · 2013 · 3 generations on107descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002607Moss Miami 6.35MM Rod System Monoaxial Screws, Polyaxial Reduction Screws and…Depuyacromed2000—
+1K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed2002—
+2K120291OP Spine SystemOrthoPediatrics Corp.2012—
+3K121630Range Spinal SystemK2m, Inc.2012—
+2K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010—
+3K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200520
200610
200740
200810
200910
201040
201160
2012100
2013140
2014120
2015140
2016170
201790
2018160
2019150
2020200
2021180
2022290
2023330
2024360
2025410
2026350
FIG. 1 — Lineage of K002607, 2000–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (339)

See all 339

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

NumberDeviceApplicantDecidedDescendants
K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed2002294
K051942Malibu Spinal SystemSeaspine, Inc.200581
K051663Malibu Spinal SystemSeaspine, Inc.200581
K061342Malibu Spinal SystemSeaspine, Inc.200680
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, K022623 (Depuyacromed, 2002) has gone furthest, with 294 descendants of its own.

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—

More from Depuyacromed

48 FDA decisions under this applicant name. See the company

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  • 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

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  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
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https://510kreport.com/device/K002607 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002607: Moss Miami 6.35MM Rod System Monoaxial Screws, Polyaxial Reduction Screws and Sacral Extenders.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002607

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026