510(k) · Cleared

Cleared

DVR® Crosslock Wrist Spanning Plate (131849181)

K220244510(k) TraditionalCleared Apr 28, 202290-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

Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech · HRS Plate, Fixation, Bone

Cleared on Apr 28, 2022 as substantially equivalent to K143749 (Arthrex, Inc., 2015) after a 90-day review. Its family tree reaches back 10 generations to 2000.

Decided: Apr 28, 2022
Review: 90 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 10 generations to K000684 (2000). 51 ancestors in all, the oldest K885250 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 10 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
6 generations between
3 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
2 generations backK131474 Arthrex Distal Radius Plate SystemArthrex, Inc. · 2013
1 generation backK143749 Arthrex Distal Radius SystemArthrex, Inc. · 2015
This deviceK220244 DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech · 2022

Show all 10 generations

Root · 10 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
9 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
8 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
7 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
6 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
5 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
4 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
3 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
2 generations backK131474 Arthrex Distal Radius Plate SystemArthrex, Inc. · 2013
1 generation backK143749 Arthrex Distal Radius SystemArthrex, Inc. · 2015
This deviceK220244 DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−10	K000684	Small Fragment Dynamic Compression Locking (DCL) System	Synthes (Usa)	2000	1
−9	K011335	Synths One-Third Tubular DCL Plate	Synthes (Usa)	2001	2
−8	K012655	Congruent Bone Plate System	Acu Med, Inc.	2001	16
−7	K021626	Hallu Plates	New Deal, S.A.	2002	—
−6	K040907	Arthrex Small Fragment Plates and Screws	Arthrex, Inc.	2004	—
−5	K052614	Low Profile Plate and Screw System	Arthrex, Inc.	2005	—
−4	K103705	Low Profile Screws	Arthrex, Inc.	2011	—
−3	K111253	Arthrex Distal Extremity Plate System	Arthrex, Inc.	2011	—
−2	K131474	Arthrex Distal Radius Plate System	Arthrex, Inc.	2013	—
−1	K143749	Arthrex Distal Radius System	Arthrex, Inc.	2015	—
0 (this device)	K220244	DVR® Crosslock Wrist Spanning Plate (131849181)	Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	2	0
1991	1	0
1994	1	0
1995	2	0
1996	9	0
1998	2	0
2000	2	0
2001	4	0
2002	4	0
2003	1	0
2004	2	0
2005	2	0
2006	2	0
2007	1	0
2008	1	0
2009	2	0
2010	2	0
2013	1	0

FIG. 1 — Lineage of K220244, 2000–2022Source: 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? (1)

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
*	K143749	Arthrex Distal Radius System	Arthrex, Inc.	2015	—
†	K000734	Pioneer Surgical Technology Extended GTR, Model 501-601	Pioneer Surgical Technology	2000	—
†	K211408	CervAlign® Anterior Cervical Plate System	Pioneer Surgical Technology, Inc.	2021	—
†	K111528	Pioneer Aspect Anterior Cervical Plate Model 24-Series	Pioneer Surgical Technology, Inc.	2011	—

Also cleared against K143749: 1 other device →

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 22 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
16 of the 51 ancestors have a recall of any class.
1 other device also cites its predicate K143749.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 DVR® Crosslock Wrist Spanning Plate is indicated for skeletally mature patients for fixation of fractures, osteotomies and non-unions of the distal radius.

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/K220244 · printed Nov 6, 2026

Cite this page

510(k) Report. “K220244: DVR® Crosslock Wrist Spanning Plate (131849181).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220244

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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