510(k) · Cleared

Cleared

Shoulder Nail Plate

K052294510(k) TraditionalCleared Oct 21, 200559-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

Hand Innovations, LLC · HRS Plate, Fixation, Bone

Cleared on Oct 21, 2005 as substantially equivalent to K051728 (Hand Innovations, LLC, 2005) and 2 other predicates after a 59-day review. Its family tree reaches back 3 generations to 1996.

Decided: Oct 21, 2005
Review: 59 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K962616 (1996). 8 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
2 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
1 generation backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
This deviceK052294 Shoulder Nail PlateHand Innovations, LLC · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K962616	Synthes Dorsal Distal Radius Plate (DDRP) System	Synthes (Usa)	1996	—
−2	K982732	Synthes (Usa) Distal Radius Plate System (DRPS)	Synthes	1998	—
−1	K023007	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2002	—
0 (this device)	K052294	Shoulder Nail Plate	Hand Innovations, LLC	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2000	1	0
2004	2	0
2005	1	0

FIG. 1 — Lineage of K052294, 1996–2005Source: 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
*	K051728	Modification to Shoulder Fixation System Summary page 1 …houlder Nail Plate is substantially equivalent to the following predicate Predicate devices: Devices * Shoulder Fixation System, 510(k) No. K051728- June 20, 2005 - Hand Innovations, LLC * Dorsal Nail Plate of the Distal R…	Hand Innovations, LLC	2005	—
*	K023007	Distal Radius Fracture Repair System Summary page 1 …Innovations, LLC * Dorsal Nail Plate of the Distal Radius Fracture Repair System, 510(k) No. K023007 - December 5, 2002 - Hand Innovations, LLC * T2TM Proximal Humeral Nailing System, 510(k) No. K043404 -…	Hand Innovations, Inc.	2002	—
*	K043404	Modification to T2 Proximal Humeral Nail Summary page 1 …, 510(k) No. K023007 - December 5, 2002 - Hand Innovations, LLC * T2TM Proximal Humeral Nailing System, 510(k) No. K043404 - December 27, 2004 - Stryker Corporation. Classification Class 11. Performance…	Howmedica Osteonics Corp.	2004	—

Also cleared against K051728: 3 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 9 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
None of the 8 ancestors has a recall.
3 other devices also cite its predicate K051728.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Shoulder Nail Plate of the Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052294 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052294: Shoulder Nail Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052294

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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