510(k) · Cleared

Cleared

Distal Elbow Plating System

K140892510(k) TraditionalCleared Aug 28, 2014142-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

Skeletal Dynamics, LLC · HRS Plate, Fixation, Bone

Cleared on Aug 28, 2014 as substantially equivalent to K082300 (DePuy Orthopaedics, Inc., 2009) after a 142-day review. Its family tree reaches back 1 generation to 2009. 2 later devices descend from it.

Decided: Aug 28, 2014
Review: 142 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K082300 (2009). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK082300 Anatomic Locking Plating SystemDePuy Orthopaedics, Inc. · 2009 · Recalled
This deviceK140892 Distal Elbow Plating SystemSkeletal Dynamics, LLC · 2014
Descendant · cites it directly · 1 of its ownK171590 Distal Elbow Plating SystemSkeletal Dynamics, LLC · 2017
Descendant · cites it directly · 0 of its ownK231623 Distal Elbow Plating SystemSkeletal Dynamics, Inc. · 2023

Most influential descendants

Showing 2 of 2 · See all

K171590Distal Elbow Plating SystemSkeletal Dynamics, LLC · 2017 · cites it directly1descendant
K231623Distal Elbow Plating SystemSkeletal Dynamics, Inc. · 2023 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K082300	Anatomic Locking Plating System	DePuy Orthopaedics, Inc.	2009	2
0 (this device)	K140892	Distal Elbow Plating System	Skeletal Dynamics, LLC	2014	—
+1	K171590	Distal Elbow Plating System	Skeletal Dynamics, LLC	2017	—
+1	K231623	Distal Elbow Plating System	Skeletal Dynamics, Inc.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0
2023	1	0

FIG. 1 — Lineage of K140892, 2009–2023Source: 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? (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
*	K082300	Anatomic Locking Plating System Summary page 4 …Plate, fixation, bone Classification 21 CFR §888.3030 Product Code HRS, HWC Class Class II Predicate Devices: DePuy Anatomic Locking Plating System (K082300) Description of the Device: The Skeletal Dynamics Distal Elbow System consists of various bone plates designed for fracture fixa…	DePuy Orthopaedics, Inc.	2009	2

Also cleared against K082300: 9 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K171590	Distal Elbow Plating System	Skeletal Dynamics, LLC	2017	1
K231623	Distal Elbow Plating System	Skeletal Dynamics, Inc.	2023	0

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 a recall.
Of its descendants, K171590 (Skeletal Dynamics, LLC, 2017) has gone furthest, with 1 descendant of its own.
9 other devices also cite its predicate K082300.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Skeletal Dynamics Distal Elbow Plating System is intended for

fixation of fractures, fusions, osteotomies and non-unions of the radius and ulna,

particularly in osteopenic bone.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140892 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140892: Distal Elbow Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140892

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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