510(k) Report

510(k) · Cleared

Cleared

Intramedullary Hip Screw

K921786510(k) TraditionalCleared Jul 17, 199294-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

Smith & Nephew Richards, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Jul 17, 1992 after a 94-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.

Decided
Jul 17, 1992
Review
94 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
0

22 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2012: 2 descendants cleared2018: 1 descendant cleared2004: 2 descendants cleared2023: 3 descendants cleared2013: 1 descendant cleared2014: 1 descendant cleared2011: 2 descendants cleared2020: 2 descendants cleared2021: 1 descendant cleared2019: 1 descendant cleared2022: 1 descendant cleared2025: 2 descendants cleared2026: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK921786 Intramedullary Hip ScrewSmith & Nephew Richards, Inc. · 1992
  2. Descendant · cites it directly · 13 of its ownK021008 Advanced Orthopaedic Solutions Trochanteric NailAdvanced Orthopaedic Solutions, Inc. · 2002 · Recalled
  3. Descendant · 2 generations on · 11 of its ownK103533 ES Trochanteric Nail, Left and Right, 10MMAdvanced Orthopaedic Solutions, Inc. · 2011
  4. Descendant · 2 generations on · 6 of its ownK120148 Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc. · 2012
  5. Descendant · 2 generations on · 4 of its ownK202099 AOS Galileo™ Trochanteric Nail SystemAdvanced Orthopaedic Solutions, Inc. · 2020
  6. Descendant · 2 generations on · 2 of its ownK140601 Flow-NailFlow-Fx, LLC · 2014

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2002: 12004: 22011: 22012: 22013: 12014: 12018: 12019: 12020: 22021: 12022: 12023: 32024: 12025: 22026: 1
2002high 3 (2023) · low 0 (2003)2026

Most influential descendants

Showing 5 of 22 · See all
  • K021008Advanced Orthopaedic Solutions Trochanteric NailAdvanced Orthopaedic Solutions, Inc. · 2002 · cites it directly13descendants
  • K103533ES Trochanteric Nail, Left and Right, 10MMAdvanced Orthopaedic Solutions, Inc. · 2011 · 2 generations on11descendants
  • K120148Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc. · 2012 · 2 generations on6descendants
  • K202099AOS Galileo™ Trochanteric Nail SystemAdvanced Orthopaedic Solutions, Inc. · 2020 · 2 generations on4descendants
  • K140601Flow-NailFlow-Fx, LLC · 2014 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K921786Intramedullary Hip ScrewSmith & Nephew Richards, Inc.1992—
+1K021008Advanced Orthopaedic Solutions Trochanteric NailAdvanced Orthopaedic Solutions, Inc.200212
+2K103533ES Trochanteric Nail, Left and Right, 10MMAdvanced Orthopaedic Solutions, Inc.2011—
+2K120148Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc.2012—
+2K202099AOS Galileo™ Trochanteric Nail SystemAdvanced Orthopaedic Solutions, Inc.2020—
+2K140601Flow-NailFlow-Fx, LLC2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200420
201120
201220
201310
201410
201810
201910
202020
202110
202210
202330
202410
202520
202610
FIG. 1 — Lineage of K921786, 1992–2026Source: 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 21.4 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K021008Advanced Orthopaedic Solutions Trochanteric NailAdvanced Orthopaedic Solutions, Inc.200213
K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122
K033286Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi)20042
K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181

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, K021008 (Advanced Orthopaedic Solutions, Inc., 2002) has gone furthest, with 13 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 Smith & Nephew Richards, Inc.

93 FDA decisions under this applicant name. See the company

  • P810020/S005OsteopalSmith & Nephew Richards, Inc. · 1998
  • P810020/S004Palacos E-Flow (Osteopal) Bone CementSmith & Nephew Richards, Inc. · 1998
  • K965224Empower Anterior Direct ScrewsSmith & Nephew Richards, Inc. · 1997
  • K963509Global Taper Tapered Hip System, GT SpectronSmith & Nephew Richards, Inc. · 1997
  • K960444Finn Rod to Rod ConnectorSmith & Nephew Richards, Inc. · 1997

Recent decisions in KTT

The KTT category page

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  • K260900DYNEX® External Fixation SystemsVilex, LLC · 2026
  • K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc. · 2026
  • K253291Excelsior SystemBlue Ocean Global · 2026

https://510kreport.com/device/K921786 · printed Nov 5, 2026

Cite this page

510(k) Report. “K921786: Intramedullary Hip Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K921786

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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