510(k) · Cleared

Cleared

Hallu Plates

K021626510(k) TraditionalCleared Aug 12, 200287-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

New Deal, S.A. · HRS Plate, Fixation, Bone

Cleared on Aug 12, 2002 as substantially equivalent to K935448 (Howmedica Corp., 1994) and 3 other predicates after an 87-day review. Its family tree reaches back 3 generations to 2000. 280 later devices descend from it.

Decided: Aug 12, 2002
Review: 87 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K000684 (2000). 10 ancestors in all, the oldest K890939 (1989). 280 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 3 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
2 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
1 generation backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
This deviceK021626 Hallu PlatesNew Deal, S.A. · 2002
Descendant · cites it directly · 249 of its ownK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
Descendant · 2 generations on · 245 of its ownK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
Descendant · 3 generations on · 219 of its ownK103705 Low Profile ScrewsArthrex, Inc. · 2011
Descendant · 4 generations on · 135 of its ownK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
Descendant · cites it directly · 92 of its ownK050681 Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005

Showing 5 of 280 descendants. See all descendants

Descendants cleared per year

2004high 36 (2026) · low 0 (2006)2026

Most influential descendants

Showing 5 of 280 · See all

K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004 · cites it directly249descendants
K052614Low Profile Plate and Screw SystemArthrex, Inc. · 2005 · 2 generations on245descendants
K103705Low Profile ScrewsArthrex, Inc. · 2011 · 3 generations on219descendants
K111253Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011 · 4 generations on135descendants
K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005 · cites it directly92descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K000684	Small Fragment Dynamic Compression Locking (DCL) System	Synthes (Usa)	2000	1
−2	K011335	Synths One-Third Tubular DCL Plate	Synthes (Usa)	2001	2
−1	K012655	Congruent Bone Plate System	Acu Med, Inc.	2001	16
0 (this device)	K021626	Hallu Plates	New Deal, S.A.	2002	—
+1	K040907	Arthrex Small Fragment Plates and Screws	Arthrex, Inc.	2004	—
+2	K052614	Low Profile Plate and Screw System	Arthrex, Inc.	2005	—
+3	K103705	Low Profile Screws	Arthrex, Inc.	2011	—
+4	K111253	Arthrex Distal Extremity Plate System	Arthrex, Inc.	2011	—
+1	K050681	Omnitech System & Easy Lock Osteosystem with Xtremities Plates	TriMed, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	1	0
1994	1	0
1995	1	0
1996	1	0
2000	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	4	0
2007	1	0
2009	2	0
2010	1	0
2011	6	0
2012	4	0
2013	8	0
2014	10	0
2015	17	0
2016	5	0
2017	28	0
2018	8	0
2019	15	0
2020	21	0
2021	18	0
2022	17	0
2023	24	0
2024	27	0
2025	27	0
2026	36	0

FIG. 1 — Lineage of K021626, 2000–2026Source: 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

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What was it cleared against? (4)

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
*	K935448	Luhr Mini Bone Screw and Z Plate Summary page 2 …lar instability. N. PREDICATE DEVICE: The HALLU@- PLATES are substantially equivalent to the Howmedica Luhr@ plate (K935448) and Howmedica Profyle@ Hand and Small Fragment System (K961497) , the Acumed…	Howmedica Corp.	1994	—
*	K961497	Profyle Titanium Hand and Small Fragment System Summary page 2 …antially equivalent to the Howmedica Luhr@ plate (K935448) and Howmedica Profyle@ Hand and Small Fragment System (K961497) , the Acumed Congruent bone plate system (K012655) and the Synthes modul…	Howmedica, Inc.	1996	—
*	K012655	Congruent Bone Plate System Summary page 2 …935448) and Howmedica Profyle@ Hand and Small Fragment System (K961497) , the Acumed Congruent bone plate system (K012655) and the Synthes modular foot system (KOO1941). 0. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:…	Acu Med, Inc.	2001	16
*	K001941	Synthes Modular Foot System	Synthes (Usa)	2000	1

Also cleared against K935448: 2 other devices →

What descends from it? (280)

See all 280

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

Number	Device	Applicant	Decided	Descendants
K040907	Arthrex Small Fragment Plates and Screws	Arthrex, Inc.	2004	249
K050681	Omnitech System & Easy Lock Osteosystem with Xtremities Plates	TriMed, Inc.	2005	92
K112794	Eos Small Bone Fixation System	TriMed, Inc.	2012	9
K083154	Newdeal Hallu Lock Plate System	Newdeal Sas	2009	2
K093781	Modified: Newdeal Hallu Plates	Newdeal Sas	2010	1

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 2 years and passes through 3 companies; a new generation was cleared every 9 months on median.
4 of the 10 ancestors have a recall of any class.
Of its descendants, K040907 (Arthrex, Inc., 2004) has gone furthest, with 249 descendants of its own.
2 other devices also cite its predicate K935448.

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 HALLUO-PLATES are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Examples include:

-Hallux rigidus

-Severe hallux valgus (IM angle > 20" and HV angle > 40")

-Deformity from rheumatoid arthritis

-Failed previous surgical procedure

-Traumatic arthritis

-Neuromuscular instability

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021626 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021626: Hallu Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021626

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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