510(k) Report

510(k) · Cleared

Cleared

Ace/Kyle Captured Hip Screw

K813554510(k) TraditionalCleared Jan 12, 198221-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

Ace Orthopedic Manufacturing Co. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Jan 12, 1982 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 41 later devices descend from it.

Decided
Jan 12, 1982
Review
21 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
0

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

Descendants, by year cleared 2012: 1 descendant cleared2007: 1 descendant cleared2008: 1 descendant cleared2014: 2 descendants cleared2018: 4 descendants cleared2009: 1 descendant cleared2022: 4 descendants cleared2021: 2 descendants cleared2013: 1 descendant cleared2025: 8 descendants cleared2023: 3 descendants cleared2026: 3 descendants cleared2024: 7 descendants cleared2017: 2 descendants cleared2020: 1 descendant cleared19801990200020102020
  1. This deviceK813554 Ace/Kyle Captured Hip ScrewAce Orthopedic Manufacturing Co. · 1982
  2. Descendant · cites it directly · 35 of its ownK080434 Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc. · 2008
  3. Descendant · cites it directly · 35 of its ownK063509 Depuy Peak FX Hip PlateDePuy Orthopaedics, Inc. · 2007
  4. Descendant · 2 generations on · 34 of its ownK090656 Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc. · 2009
  5. Descendant · 2 generations on · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
  6. Descendant · 3 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12009: 12012: 12013: 12014: 22017: 22018: 42020: 12021: 22022: 42023: 32024: 72025: 82026: 3
2007high 8 (2025) · low 0 (2010)2026

Most influential descendants

Showing 5 of 41 · See all
  • K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc. · 2008 · cites it directly35descendants
  • K063509Depuy Peak FX Hip PlateDePuy Orthopaedics, Inc. · 2007 · cites it directly35descendants
  • K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc. · 2009 · 2 generations on34descendants
  • K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · 2 generations on33descendants
  • K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 3 generations on32descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K813554Ace/Kyle Captured Hip ScrewAce Orthopedic Manufacturing Co.1982—
+1K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.2008—
+1K063509Depuy Peak FX Hip PlateDePuy Orthopaedics, Inc.2007—
+2K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc.2009—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.2013—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.20142

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
200910
201210
201310
201420
201720
201840
202010
202120
202240
202330
202470
202580
202630
FIG. 1 — Lineage of K813554, 1982–2026Source: 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
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? (41)

See all 41

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

NumberDeviceApplicantDecidedDescendants
K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835
K063509Depuy Peak FX Hip PlateDePuy Orthopaedics, Inc.200735
K140018TSP Hip Fracture Plating SystemBiomet, Inc.20141
K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.20121
K173826THP Hip Fracture Plating SystemBiomet, Inc.20180

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, K080434 (Smith & Nephew, Inc., 2008) has gone furthest, with 35 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 Ace Orthopedic Manufacturing Co.

14 FDA decisions under this applicant name. See the company

  • K934962Aim Supracondylar NailAce Orthopedic Manufacturing Co. · 1994
  • K934643Ace Humeral NailAce Orthopedic Manufacturing Co. · 1994
  • K936045Ace Unilateral Fixator IIAce Orthopedic Manufacturing Co. · 1994
  • K926047Ace 8.0MM Cannulated Cancellous Bone ScrewAce Orthopedic Manufacturing Co. · 1993
  • K920738Ace 100 Degrees Tubular PlateAce Orthopedic Manufacturing Co. · 1992

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/K813554 · printed Nov 6, 2026

Cite this page

510(k) Report. “K813554: Ace/Kyle Captured 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/K813554

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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