510(k) · Cleared

Cleared

AOS Calcaneal Plating System

K182466510(k) TraditionalCleared Oct 30, 201850-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

Advanced Orthopaedic Solutions · HRS Plate, Fixation, Bone

Cleared on Oct 30, 2018 as substantially equivalent to K011335 (Synthes (Usa), 2001) and 2 other predicates after a 50-day review. Its family tree reaches back 4 generations to 2000.

Decided: Oct 30, 2018
Review: 50 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K000684 (2000). 7 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
3 generations backK152732 AOS Small Fragment Plating SystemAvanced Orthopaedic Solutions, Inc. (Aos) · 2015
2 generations backK161913 AOS Small Fragment Plating SystemAdvanced Orthopaedic Solutions, Inc. (Aos) · 2016
1 generation backK181035 AOS Small Fragment Plating System LiteAdvanced Orthopaedic Solutions, Inc. (Aos) · 2018
This deviceK182466 AOS Calcaneal Plating SystemAdvanced Orthopaedic Solutions · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K000684	Small Fragment Dynamic Compression Locking (DCL) System	Synthes (Usa)	2000	1
−3	K152732	AOS Small Fragment Plating System	Avanced Orthopaedic Solutions, Inc. (Aos)	2015	—
−2	K161913	AOS Small Fragment Plating System	Advanced Orthopaedic Solutions, Inc. (Aos)	2016	—
−1	K181035	AOS Small Fragment Plating System Lite	Advanced Orthopaedic Solutions, Inc. (Aos)	2018	—
0 (this device)	K182466	AOS Calcaneal Plating System	Advanced Orthopaedic Solutions	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2006	1	0
2008	1	0

FIG. 1 — Lineage of K182466, 2000–2018Source: 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
*	K011335	Synths One-Third Tubular DCL Plate	Synthes (Usa)	2001	2
*	K063049	Synthes (Usa) Modular Mini Fragment LCP System Summary page 4 …0 Single/multiple component metallic bone fixation appliances and accessories HRS Synthes One-Third Tubular DCL Plate, KO11335 Synthes (USA) Modular Mini Fragment LCP, K063049; AOS Small Fragment Plate System Lite, K181035 The AOS Calcaneal Plating System consists of titanium plates in various configur…	Synthes (Usa)	2006	4
*	K181035	AOS Small Fragment Plating System Lite Summary page 4 …on appliances and accessories HRS Synthes One-Third Tubular DCL Plate, KO11335 Synthes (USA) Modular Mini Fragment LCP, K063049; AOS Small Fragment Plate System Lite, K181035 The AOS Calcaneal Plating System consists of titanium plates in various configurations and sizes. The system is compatible with…	Advanced Orthopaedic Solutions, Inc. (Aos)	2018	—

Also cleared against K011335: 42 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
3 of the 7 ancestors have a recall of any class.
42 other devices also cite its predicate K011335.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 AOS Calcaneal Plating System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K182466 · printed Nov 6, 2026

Cite this page

510(k) Report. “K182466: AOS Calcaneal 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/K182466

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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