510(k) · Cleared

Cleared

Integra Proximal Humeral Plate System

K121826510(k) TraditionalCleared Feb 13, 2013237-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

Ascension Orthopedics, Inc. · HRS Plate, Fixation, Bone

Cleared on Feb 13, 2013 as substantially equivalent to K011815 (Synthes (Usa), 2001) and 1 other predicate after a 237-day review. Its family tree reaches back 2 generations to 2001.

Decided: Feb 13, 2013
Review: 237 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K011815 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK011815 Synthes LCP Proximal Humerus PlatesSynthes (Usa) · 2001
1 generation backK110700 Ascension Atlas Humeral Plating SystemAscension Orthopedics, Inc. · 2011
This deviceK121826 Integra Proximal Humeral Plate SystemAscension Orthopedics, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K011815	Synthes LCP Proximal Humerus Plates	Synthes (Usa)	2001	—
−1	K110700	Ascension Atlas Humeral Plating System	Ascension Orthopedics, Inc.	2011	—
0 (this device)	K121826	Integra Proximal Humeral Plate System	Ascension Orthopedics, Inc.	2013	—

FIG. 1 — Lineage of K121826, 2001–2013Source: 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? (2)

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
*	K011815	Synthes LCP Proximal Humerus Plates Summary page 1 …nent metallic bone fixation appliances and accessories PRODUCT CODE: HRS PANEL: Orthopedic PREDICATE DEVICE: K011815 -Synthes LCP Proximal Humerus Plate K010700-ATLAS Humeral Plate System DEVICE DESCRIPTION: The Inte…	Synthes (Usa)	2001	—
*	K110700	Ascension Atlas Humeral Plating System Our reading of the summary gave K010700, FDA’s number for Randox Myoglobin (Randox Laboratories, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ATLAS Humeral Plate System”.	Ascension Orthopedics, Inc.	2011	—
†	K110700	Ascension Atlas Humeral Plating System	Ascension Orthopedics, Inc.	2011	—

Also cleared against K011815: 24 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 12 years and passes through 2 companies; a new generation was cleared every 10.2 years on median.
None of the 2 ancestors has a recall.
24 other devices also cite its predicate K011815.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Integra Proximal Humeral Fracture Plate System is designed for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus. Indications include:

Dislocated two-, three-, and four-fragment fractures of the proximal humerus, including fractures involving osteopenic bone

Pseudoarthroses in the proximal humerus

Osteotomies in the proximal humerus

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121826 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121826: Integra Proximal Humeral Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121826

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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