510(k) Report

510(k) · Cleared

Cleared

Dynamic Hip Screw

K791619510(k) TraditionalCleared Aug 28, 19797-day reviewClass II21 CFR 888.3030

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

Synthes (Usa) · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Aug 28, 1979 after a 7-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 65 later devices descend from it.

Decided
Aug 28, 1979
Review
7 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
0

65 later devices descend from it, 12 citing it directly.

Descendants, by year cleared 2007: 3 descendants cleared1999: 1 descendant cleared1997: 4 descendants cleared2023: 4 descendants cleared2015: 3 descendants cleared2021: 3 descendants cleared1996: 1 descendant cleared2018: 4 descendants cleared2019: 4 descendants cleared2012: 3 descendants cleared2002: 1 descendant cleared2003: 1 descendant cleared2014: 1 descendant cleared2004: 2 descendants cleared2005: 3 descendants cleared2011: 4 descendants cleared2010: 2 descendants cleared2025: 2 descendants cleared2020: 4 descendants cleared2006: 1 descendant cleared2013: 4 descendants cleared2016: 3 descendants cleared2017: 3 descendants cleared2022: 1 descendant cleared2026: 2 descendants cleared2024: 1 descendant cleared19801990200020102020
  1. This deviceK791619 Dynamic Hip ScrewSynthes (Usa) · 1979
  2. Descendant · cites it directly · 42 of its ownK972629 Depuy AE TK2 Hip Screw SystemDepuy, Inc. · 1997 · Recalled
  3. Descendant · 2 generations on · 32 of its ownK031401 Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd. · 2003
  4. Descendant · 3 generations on · 31 of its ownK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
  5. Descendant · 4 generations on · 29 of its ownK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
  6. Descendant · 4 generations on · 16 of its ownK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled

Showing 5 of 65 descendants. See all descendants

Descendants cleared per year

1996: 11997: 41999: 12002: 12003: 12004: 22005: 32006: 12007: 32010: 22011: 42012: 32013: 42014: 12015: 32016: 32017: 32018: 42019: 42020: 42021: 32022: 12023: 42024: 12025: 22026: 2
1996high 4 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 65 · See all
  • K972629Depuy AE TK2 Hip Screw SystemDepuy, Inc. · 1997 · cites it directly42descendants
  • K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd. · 2003 · 2 generations on32descendants
  • K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010 · 3 generations on31descendants
  • K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010 · 4 generations on29descendants
  • K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · 4 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K791619Dynamic Hip ScrewSynthes (Usa)1979—
+1K972629Depuy AE TK2 Hip Screw SystemDepuy, Inc.19972
+2K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd.2003—
+3K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.2010—
+4K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.2010—
+4K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.20111

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199740
199910
200210
200310
200420
200530
200610
200730
201020
201140
201230
201340
201410
201530
201630
201730
201840
201940
202040
202130
202210
202340
202410
202520
202620
FIG. 1 — Lineage of K791619, 1979–2026Source: 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 KTT? 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 KTT device

  1. #1 K242861 TrueLok Elevatescore 21.3 · 14 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? (65)

See all 65

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

NumberDeviceApplicantDecidedDescendants
K972629Depuy AE TK2 Hip Screw SystemDepuy, Inc.199742
K970258Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck…Ferguson Medical19978
K071852Aap Aps SystemAap Implantate AG20074
K984331Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc.19993
K172872DePuy Synthes Femoral Neck SystemDePuy Synthes20182
K150818Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral…Zimmer, Inc.20152
K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211
K221787Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited20230
K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190
K971993Odi Compression Hip Screw SystemOrthopaedic Designs, Inc.19970

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, K972629 (Depuy, Inc., 1997) has gone furthest, with 42 descendants of its own.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

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

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
2007high 14 (2018) · low 0 (2011)2026

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

Adverse event reports per year · KTT

673in 2025

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

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  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

Recent decisions in KTT

The KTT category page

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https://510kreport.com/device/K791619 · printed Nov 6, 2026

Cite this page

510(k) Report. “K791619: Dynamic Hip Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K791619

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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