510(k) Report

510(k) · Cleared

Cleared

Intramedullary Hip Screw (Modification)

K954712510(k) TraditionalCleared Oct 31, 199576-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 Oct 31, 1995 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 35 later devices descend from it.

Decided
Oct 31, 1995
Review
76 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 3 descendants cleared2002: 1 descendant cleared2022: 2 descendants cleared2021: 1 descendant cleared2023: 5 descendants cleared2013: 2 descendants cleared2014: 1 descendant cleared2011: 2 descendants cleared2020: 1 descendant cleared2012: 2 descendants cleared2009: 1 descendant cleared2005: 1 descendant cleared2025: 5 descendants cleared2026: 3 descendants cleared2018: 1 descendant cleared2010: 1 descendant cleared2019: 1 descendant cleared2024: 2 descendants cleared1995200020052010201520202025
  1. This deviceK954712 Intramedullary Hip Screw (Modification)Smith & Nephew Richards, Inc. · 1995
  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 · cites it directly · 9 of its ownK040656 Modification to Smith & Nephew Intramedullary Hip ScrewSmith & Nephew, Inc. · 2004
  5. Descendant · cites it directly · 7 of its ownK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · Recalled
  6. Descendant · 2 generations on · 7 of its ownK050226 Asian Intramedullary Hip Screw NailsSmith & Nephew, Inc. · 2005

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2002: 12004: 32005: 12009: 12010: 12011: 22012: 22013: 22014: 12018: 12019: 12020: 12021: 12022: 22023: 52024: 22025: 52026: 3
2002high 5 (2023) · low 0 (2003)2026

Most influential descendants

Showing 5 of 35 · 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
  • K040656Modification to Smith & Nephew Intramedullary Hip ScrewSmith & Nephew, Inc. · 2004 · cites it directly9descendants
  • K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · cites it directly7descendants
  • K050226Asian Intramedullary Hip Screw NailsSmith & Nephew, Inc. · 2005 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954712Intramedullary Hip Screw (Modification)Smith & Nephew Richards, Inc.1995—
+1K021008Advanced Orthopaedic Solutions Trochanteric NailAdvanced Orthopaedic Solutions, Inc.200212
+2K103533ES Trochanteric Nail, Left and Right, 10MMAdvanced Orthopaedic Solutions, Inc.2011—
+1K040656Modification to Smith & Nephew Intramedullary Hip ScrewSmith & Nephew, Inc.2004—
+1K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.20211
+2K050226Asian Intramedullary Hip Screw NailsSmith & Nephew, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200430
200510
200910
201010
201120
201220
201320
201410
201810
201910
202010
202110
202220
202350
202420
202550
202630
FIG. 1 — Lineage of K954712, 1995–2026Source: 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? (35)

See all 35

5 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
K040656Modification to Smith & Nephew Intramedullary Hip ScrewSmith & Nephew, Inc.20049
K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.20217
K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.20222
K033286Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi)20042

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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https://510kreport.com/device/K954712 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954712: Intramedullary Hip Screw (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954712

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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