510(k) · Cleared

Cleared

Depuy Peak FX Hip Plate

K063509510(k) TraditionalCleared Jan 4, 200745-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

DePuy Orthopaedics, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Jan 4, 2007 as substantially equivalent to K813554 (Ace Orthopedic Manufacturing Co., 1982) after a 45-day review. Its family tree reaches back 1 generation to 1982. 35 later devices descend from it.

Decided: Jan 4, 2007
Review: 45 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K813554 (1982). 35 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK813554 Ace/Kyle Captured Hip ScrewAce Orthopedic Manufacturing Co. · 1982
This deviceK063509 Depuy Peak FX Hip PlateDePuy Orthopaedics, Inc. · 2007
Descendant · cites it directly · 34 of its ownK090656 Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc. · 2009
Descendant · 2 generations on · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
Descendant · 3 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
Descendant · 4 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
Descendant · 5 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2009high 7 (2024) · low 0 (2010)2026

Most influential descendants

Showing 5 of 35 · See all

K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc. · 2009 · cites it directly34descendants
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
K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 4 generations on14descendants
K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 5 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K813554	Ace/Kyle Captured Hip Screw	Ace Orthopedic Manufacturing Co.	1982	—
0 (this device)	K063509	Depuy Peak FX Hip Plate	DePuy Orthopaedics, Inc.	2007	—
+1	K090656	Intertan CHS Limited Collapse Set Screw	Smith & Nephew, Inc.	2009	—
+2	K123055	Smith & Nephew, Inc Screw and Plate System Instrumentation	Smith & Nephew, Inc.	2013	—
+3	K140814	Evos Mini-Fragment Plating System	Smith & Nephew, Inc.	2014	2
+4	K163361	ANTHEM™ Fracture System	Globus Medical, Inc.	2017	—
+5	K173166	ANTHEM Fracture System	Globus Medical, Inc.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2013	1	0
2014	1	0
2017	2	0
2018	3	0
2020	1	0
2021	2	0
2022	4	0
2023	3	0
2024	7	0
2025	7	0
2026	3	0

FIG. 1 — Lineage of K063509, 1982–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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 K242861 TrueLok Elevatescore 21.3 · 14 generations · no Class I recall
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K813554	Ace/Kyle Captured Hip Screw Summary page 1 …ODUCT CODE: 87 KTT SUBSTANTIALLY EQUIVALENT DePuy Captured Hip Screw System (CHS), DEVICES: K813554, cleared on January 12, 1982 DEVICE DESCRIPTION: The DePuy Peak Fx Hip Plate System is comprised of plates in various lengths…	Ace Orthopedic Manufacturing Co.	1982	—

Also cleared against K813554: 4 other devices →

What descends from it? (35)

See all 35

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

Number	Device	Applicant	Decided	Descendants
K090656	Intertan CHS Limited Collapse Set Screw	Smith & Nephew, Inc.	2009	34

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?

Its one ancestor has no recall.
Of its descendants, K090656 (Smith & Nephew, Inc., 2009) has gone furthest, with 34 descendants of its own.
4 other devices also cite its predicate K813554.

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. 2007, this device’s year, is highlighted.

FDA decisions per year · KTT

10in 2025

2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007high 200 (2020) · low 25 (2022)2026

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

Recalls per year · KTT

2in 2021

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	9	55	2	45
2008	11	73	1	66
2009	11	94	2	45
2010	12	148	1	121
2011	10	157	0	196
2012	9	140	4	527
2013	7	87	7	898
2014	14	129	0	445
2015	12	60	0	401
2016	10	142	0	400
2017	11	184	1	485
2018	6	149	14	597
2019	8	110	3	800
2020	9	200	0	942
2021	10	83	2	961
2022	3	25	0	627
2023	7	29	0	554
2024	5	90	0	523
2025	10	88	0	673
2026	5	68	11	—

What is it indicated for?

The Peak Fx Hip Plate is indicated for the following fractures of the proximal femur:

* Basilar neck fractures

* Intertrochanteric fractures

* Subtrochanteric fractures

The Peak Fx Hip Plate is indicated for stable and unstable fractures in which a stable medial buttress can be reconstructed.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063509 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063509: Depuy Peak FX Hip Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063509

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026