510(k) · Cleared

Cleared

Small Titanium Wrist Fusion Plate

K023879510(k) TraditionalCleared Feb 5, 200376-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

Synthes (Usa) · HRS Plate, Fixation, Bone

Cleared on Feb 5, 2003 after a 76-day review. The FDA summary names its predicate without a number. 167 later devices descend from it.

Decided: Feb 5, 2003
Review: 76 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

167 later devices descend from it, 5 citing it directly.

This deviceK023879 Small Titanium Wrist Fusion PlateSynthes (Usa) · 2003
Descendant · cites it directly · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
Descendant · cites it directly · 50 of its ownK102694 2.4MM VA-LCP Dorsal Distal Radius PlatesSynthes (Usa) · 2010 · Recalled
Descendant · 2 generations on · 44 of its ownK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
Descendant · 2 generations on · 33 of its ownK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
Descendant · 3 generations on · 23 of its ownK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015

Showing 5 of 167 descendants. See all descendants

Descendants cleared per year

2010high 25 (2026) · low 2 (2010)2026

Most influential descendants

Showing 5 of 167 · See all

K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · cites it directly118descendants
K1026942.4MM VA-LCP Dorsal Distal Radius PlatesSynthes (Usa) · 2010 · cites it directly50descendants
K120854Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012 · 2 generations on44descendants
K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC · 2017 · 2 generations on33descendants
K143385Acumed Ankle Plating SystemAcumed, LLC · 2015 · 3 generations on23descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K023879	Small Titanium Wrist Fusion Plate	Synthes (Usa)	2003	—
+1	K112583	Synthes Cortical Screws	Synthes (USA) Products, LLC	2011	—
+1	K102694	2.4MM VA-LCP Dorsal Distal Radius Plates	Synthes (Usa)	2010	3
+2	K120854	Synthes VA LCP Ankle Trauma System	Synthes USA	2012	—
+2	K161616	DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated…	Synthes USA Products, LLC	2017	—
+3	K143385	Acumed Ankle Plating System	Acumed, LLC	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	2	0
2011	2	0
2012	4	0
2013	3	0
2014	3	0
2015	7	0
2016	5	0
2017	11	0
2018	9	0
2019	11	0
2020	10	0
2021	15	0
2022	11	0
2023	10	0
2024	24	0
2025	15	0
2026	25	0

FIG. 1 — Lineage of K023879, 2003–2026Source: 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

Get a 510(k) Report

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
*	—	Synthes Straight Wrist Fusion Plate Named without a submission number			—
*	—	Biomet Colles Fracture Plate Named without a submission number			—

What descends from it? (167)

See all 167

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

Number	Device	Applicant	Decided	Descendants
K112583	Synthes Cortical Screws	Synthes (USA) Products, LLC	2011	118
K102694	2.4MM VA-LCP Dorsal Distal Radius Plates	Synthes (Usa)	2010	50
K112169	Aptus Wrist Arthrodesis Plates	Medartis AG	2012	8
K100123	Acumed Wrist Arthrodesis Plate System	Acumed, LLC	2010	1
K131380	Acumed Totalw Rist Fusion Plating System	Acumed, LLC	2013	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?

Of its descendants, K112583 (Synthes (USA) Products, LLC, 2011) has gone furthest, with 118 descendants of its own.

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 Synthes (USA) Small Titanium Wrist Fusion Plate is intended for use in plate fixation for wrist arthrodesis in patients with disorders such as cerebral palsy, brachial plexopathy, spinal cord injuries, and trauma. This plate addresses the smaller stature and pediatric patient by having a low profile construct and utilizing small screws.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023879 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023879: Small Titanium Wrist Fusion Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023879

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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