510(k) Report

510(k) · Cleared

Cleared

Synthes Uss (10.0MM Side Opening Screws)

K003061510(k) SpecialCleared Oct 30, 200028-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Synthes · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Oct 30, 2000 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 91 later devices descend from it.

Decided
Oct 30, 2000
Review
28 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

91 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2011: 2 descendants cleared2014: 2 descendants cleared2013: 2 descendants cleared2019: 3 descendants cleared2017: 3 descendants cleared2016: 1 descendant cleared2015: 1 descendant cleared2020: 5 descendants cleared2018: 2 descendants cleared2023: 12 descendants cleared2021: 3 descendants cleared2024: 15 descendants cleared2022: 8 descendants cleared2025: 16 descendants cleared2026: 15 descendants cleared200020052010201520202025
  1. This deviceK003061 Synthes Uss (10.0MM Side Opening Screws)Synthes · 2000
  2. Descendant · cites it directly · 90 of its ownK093692 Quantum/ Streamline Spinal System Model 02-Series and 10-SeriesPioneer Surgical Technology · 2010
  3. Descendant · 2 generations on · 89 of its ownK110692 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
  4. Descendant · 3 generations on · 88 of its ownK111502 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
  5. Descendant · 4 generations on · 82 of its ownK132049 Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014
  6. Descendant · 5 generations on · 73 of its ownK160775 Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP · 2016

Showing 5 of 91 descendants. See all descendants

Descendants cleared per year

2010: 12011: 22013: 22014: 22015: 12016: 12017: 32018: 22019: 32020: 52021: 32022: 82023: 122024: 152025: 162026: 15
2010high 16 (2025) · low 0 (2012)2026

Most influential descendants

Showing 5 of 91 · See all
  • K093692Quantum/ Streamline Spinal System Model 02-Series and 10-SeriesPioneer Surgical Technology · 2010 · cites it directly90descendants
  • K110692Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011 · 2 generations on89descendants
  • K111502Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011 · 3 generations on88descendants
  • K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014 · 4 generations on82descendants
  • K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP · 2016 · 5 generations on73descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003061Synthes Uss (10.0MM Side Opening Screws)Synthes2000—
+1K093692Quantum/ Streamline Spinal System Model 02-Series and 10-SeriesPioneer Surgical Technology2010—
+2K110692Streamline TL Spinal SystemPioneer Surgical Technology, Inc.2011—
+3K111502Streamline TL Spinal SystemPioneer Surgical Technology, Inc.2011—
+4K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine2014—
+5K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201120
201320
201420
201510
201610
201730
201820
201930
202050
202130
202280
2023120
2024150
2025160
2026150
FIG. 1 — Lineage of K003061, 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 KWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KWQ device

  1. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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? (91)

See all 91

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093692Quantum/ Streamline Spinal System Model 02-Series and 10-SeriesPioneer Surgical Technology201090

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, K093692 (Pioneer Surgical Technology, 2010) has gone furthest, with 90 descendants of its own.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

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11 FDA decisions under this applicant name. See the company

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  • K110604VBB SystemSynthes · 20111 recall
  • K093772Synthes Sternal Fixation SystemSynthes · 2010

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https://510kreport.com/device/K003061 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003061: Synthes Uss (10.0MM Side Opening Screws).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003061

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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