510(k) · Cleared

Cleared

Stratum™ Reduced Size Foot Plating System

K200785510(k) TraditionalCleared Jul 27, 2020123-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

Nextremity Solutions, Inc. · HRS Plate, Fixation, Bone

Cleared on Jul 27, 2020 as substantially equivalent to K081546 (DePuy Orthopaedics, Inc., 2008) and 2 other predicates after a 123-day review. Its family tree reaches back 5 generations to 2004.

Decided: Jul 27, 2020
Review: 123 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 3

Its longest line of descent runs back 5 generations to K041081 (2004). 9 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK041081 Fragment Plate System, Screws, Pins and K-WiresHand Innovations, Inc. · 2004 · Recalled
4 generations backK061748 Fragment Plate SystemHand Innovations, LLC · 2006
3 generations backK101240 Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22…DePuy Orthopaedics, Inc. · 2010
2 generations backK131670 Lapidus Plate, 3.5MM Inline Fusion Plate, 3.5MM MTP Plate (Left and…Biomet, Inc. · 2013
1 generation backK182201 Stratum™ Foot Plating SystemNextremity Solutions, Inc. · 2018 · Recalled
This deviceK200785 Stratum™ Reduced Size Foot Plating SystemNextremity Solutions, Inc. · 2020

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K041081	Fragment Plate System, Screws, Pins and K-Wires	Hand Innovations, Inc.	2004	1
−4	K061748	Fragment Plate System	Hand Innovations, LLC	2006	—
−3	K101240	Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021…	DePuy Orthopaedics, Inc.	2010	—
−2	K131670	Lapidus Plate, 3.5MM Inline Fusion Plate, 3.5MM MTP Plate (Left and Right)	Biomet, Inc.	2013	—
−1	K182201	Stratum™ Foot Plating System	Nextremity Solutions, Inc.	2018	5
0 (this device)	K200785	Stratum™ Reduced Size Foot Plating System	Nextremity Solutions, Inc.	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0
2009	1	0
2014	1	0

FIG. 1 — Lineage of K200785, 2004–2020Source: 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
*	K081546	Small Bone Locking Plating System Summary page 4 …HWC Substantially Equivalent Devices:  Zimmer Biomet F3™ Fragment Plating System (cleared as the DePuy Small Bone Locking Plating System), K081546 – Primary Predicate  Zimmer Biomet A.L.P.S. Hand Fracture (cleared as the DePuy Small Bone Locking Plating…	DePuy Orthopaedics, Inc.	2008	1
*	K140724	MSP Metatarsal Shortening System Summary page 4 …cleared as the DePuy Small Bone Locking Plating System), K081546 – Primary Predicate  Nextremity Solutions MSP Metatarsal Shortening System, K140724 – Additional Predicate  Nextremity Solutions Stratum™ Foot Plating System, K182201 – Additional Predicate === Pa…	Nextremity Solutions, Inc.	2014	—
*	K182201	Stratum™ Foot Plating System Summary page 4 … Nextremity Solutions MSP Metatarsal Shortening System, K140724 – Additional Predicate  Nextremity Solutions Stratum™ Foot Plating System, K182201 – Additional Predicate K200…	Nextremity Solutions, Inc.	2018	5

Also cleared against K081546: 10 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 16 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
4 of the 9 ancestors have a recall of any class.
10 other devices also cite its predicate K081546.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Nextremity Solutions Stratum™ Reduced Size Foot Plating System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the foot and ankle, particularly in osteopenic bone.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K200785 · printed Nov 5, 2026

Cite this page

510(k) Report. “K200785: Stratum™ Reduced Size Foot Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K200785

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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