510(k) · Cleared

Recalled · Class II · 2016

Metaizeau Nailing System

K063225510(k) TraditionalCleared Dec 27, 200664-day reviewClass II21 CFR 888.3020Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Howmedica Osteonics Corp. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Dec 27, 2006 after a 64-day review. The FDA summary names no predicate by number. 30 later devices descend from it. It has been recalled once.

Decided: Dec 27, 2006
Review: 64 days
Class: Class II
Product code: HSB
Recalls: 1
Predicates: 0

30 later devices descend from it, 2 citing it directly.

This deviceK063225 Metaizeau Nailing SystemHowmedica Osteonics Corp. · 2006
Descendant · cites it directly · 29 of its ownK081452 Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa) · 2008
Descendant · 2 generations on · 14 of its ownK082148 Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line…Synthes (Usa) · 2008
Descendant · 3 generations on · 10 of its ownK143276 Acumed Small Bone IM Nail SystemAcumed, LLC · 2015
Descendant · cites it directly · 10 of its ownK082375 Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp. · 2008
Descendant · 2 generations on · 6 of its ownK143355 The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015 · Recalled

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2008high 5 (2017) · low 0 (2009)2026

Most influential descendants

Showing 5 of 30 · See all

K081452Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa) · 2008 · cites it directly29descendants
K082148Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line ExtensionSynthes (Usa) · 2008 · 2 generations on14descendants
K143276Acumed Small Bone IM Nail SystemAcumed, LLC · 2015 · 3 generations on10descendants
K082375Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp. · 2008 · cites it directly10descendants
K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015 · 2 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K063225	Metaizeau Nailing System	Howmedica Osteonics Corp.	2006	—
+1	K081452	Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System	Synthes (Usa)	2008	—
+2	K082148	Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension	Synthes (Usa)	2008	—
+3	K143276	Acumed Small Bone IM Nail System	Acumed, LLC	2015	—
+1	K082375	Orthopediatrics Pediflex Flexible Nail System	OrthoPediatrics Corp.	2008	—
+2	K143355	The Simple Locking IntraMedullary (SLIM) System	Pega Medical, Inc.	2015	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	3	0
2015	2	0
2016	1	0
2017	5	0
2020	4	0
2021	3	0
2022	2	0
2023	1	0
2024	2	0
2025	5	0
2026	2	0

FIG. 1 — Lineage of K063225, 2006–2026Source: 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 HSB? 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 HSB device

#1 K200869 Gamma3 Systemscore 19.8 · 8 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?

The FDA summary names no predicate by number.

What descends from it? (30)

See all 30

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

Number	Device	Applicant	Decided	Descendants
K081452	Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System	Synthes (Usa)	2008	29
K082375	Orthopediatrics Pediflex Flexible Nail System	OrthoPediatrics Corp.	2008	10

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 21, 2016	Class II	Z-0868-2016	Under Investigation by firm	During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K081452 (Synthes (Usa), 2008) has gone furthest, with 29 descendants of its own.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSB

15in 2025

2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007high 195 (2024) · low 57 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HSB

18in 2025

2007high 81 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HSB

2,911in 2025

2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, 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	8	68	0	162
2008	11	57	9	184
2009	18	86	81	334
2010	14	117	18	454
2011	16	78	2	662
2012	17	112	7	1,079
2013	18	105	14	1,773
2014	19	147	3	1,474
2015	22	111	3	1,671
2016	8	124	6	1,920
2017	23	119	66	1,447
2018	17	134	56	3,526
2019	13	132	6	2,517
2020	17	112	6	3,299
2021	10	94	2	4,111
2022	12	172	1	2,733
2023	11	162	1	2,219
2024	13	195	1	2,869
2025	15	106	18	2,911
2026	18	151	1	—

What is it indicated for?

The MetaizeauTM Nailing System is intended for the temporary stabilization of bone segments or fragments until bone consolidation has been achieved. Specific indications include, but are not limited to:

* Fixation of mid-diaphyseal, proximal and distal fractures of the femur and tibia in children,

* Forearm fractures in children and young adolescents, and

* Fractures of the humerus in adults.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063225 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063225: Metaizeau Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063225

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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