510(k) · Cleared

Recalled · Class II · 2014

2.7MM LCP Ulna Osteotomy System

K113364510(k) TraditionalCleared Feb 29, 2012106-day reviewClass II21 CFR 888.3030Recalls 1

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

Synthes (USA) Products, LLC · HRS Plate, Fixation, Bone

Cleared on Feb 29, 2012 as substantially equivalent to K063049 (Synthes (Usa), 2006) and 2 other predicates after a 106-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it. It has been recalled once.

Decided: Feb 29, 2012
Review: 106 days
Class: Class II
Product code: HRS
Recalls: 1
Predicates: 3

Its longest line of descent runs back 1 generation to K001941 (2000). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK001941 Synthes Modular Foot SystemSynthes (Usa) · 2000 · Recalled
This deviceK113364 2.7MM LCP Ulna Osteotomy SystemSynthes (USA) Products, LLC · 2012
Descendant · cites it directly · 1 of its ownK130008 Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol)…I.T.S. GmbH · 2013 · Recalled
Descendant · 2 generations on · 0 of its ownK260958 I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius…I.T.S. GmbH · 2026
Descendant · cites it directly · 0 of its ownK160553 DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2017

Most influential descendants

Showing 3 of 3 · See all

K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH · 2013 · cites it directly1descendant
K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH · 2026 · 2 generations on0descendants
K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001941	Synthes Modular Foot System	Synthes (Usa)	2000	1
0 (this device)	K113364	2.7MM LCP Ulna Osteotomy System	Synthes (USA) Products, LLC	2012	—
+1	K130008	Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0…	I.T.S. GmbH	2013	1
+2	K260958	I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with…	I.T.S. GmbH	2026	—
+1	K160553	DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes…	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2017	1	0
2026	1	0

FIG. 1 — Lineage of K113364, 2000–2026Source: 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 HRS? 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 HRS device

#1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

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
*	K063049	Synthes (Usa) Modular Mini Fragment LCP System Summary page 1 …ries, HRS Class 1H,§888.3040 - Smooth or threaded metallic bone fixation fastener, HWC Predicate Device: K063049- Modular Mini Fragmernt LCP System K001941- Synthes Modular Foot System (not in comparison table)…	Synthes (Usa)	2006	4
*	K001941	Synthes Modular Foot System Summary page 1 …hreaded metallic bone fixation fastener, HWC Predicate Device: K063049- Modular Mini Fragmernt LCP System K001941- Synthes Modular Foot System (not in comparison table) K073228 - DC Ulnar Shortening System Devic…	Synthes (Usa)	2000	1
*	K073228	DC Ulnar Shortening System Summary page 1 …vice: K063049- Modular Mini Fragmernt LCP System K001941- Synthes Modular Foot System (not in comparison table) K073228 - DC Ulnar Shortening System Device Description: The 2.7mm LCP Ulna Osteotomy System consists of…	Orthopro, LLC	2008	—

Also cleared against K063049: 39 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K130008	Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…	I.T.S. GmbH	2013	1
K160553	DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	2017	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 7, 2014	Class II	Z-1274-2014	Component design/selection	The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template or jamming, bending, or breaking of the K-wire during fixation of the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 3 ancestors have a recall of any class.
Of its descendants, K130008 (I.T.S. GmbH, 2013) has gone furthest, with 1 descendant of its own.
39 other devices also cite its predicate K063049.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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	35	63	2	339
2008	35	87	11	311
2009	47	85	3	435
2010	49	100	16	491
2011	43	88	5	773
2012	59	106	4	1,663
2013	56	89	11	2,643
2014	76	57	0	2,413
2015	56	97	7	3,095
2016	44	109	5	2,276
2017	57	122	3	2,220
2018	40	116	2	2,663
2019	46	89	25	3,359
2020	48	88	1	2,790
2021	40	87	9	2,442
2022	47	144	3	1,700
2023	40	120	1	2,049
2024	54	96	0	1,849
2025	54	90	1	2,306
2026	51	82	3	—

What is it indicated for?

The 2.7mm LCP Ulna Osteotomy System is indicated for fixation of fractures, osteoomies, nohunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna. The 2.7mm LCP Ulna Osteotomy System is indicated for use in both adults and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113364 · printed Nov 5, 2026

Cite this page

510(k) Report. “K113364: 2.7MM LCP Ulna Osteotomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113364

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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