510(k) · Cleared

Recalled · Class II · 2015

Biomet Microfixation Neuro Plating System

K121624510(k) TraditionalCleared Oct 12, 2012133-day reviewClass II21 CFR 882.5320Recalls 2

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

Biomet Microfixation · GWO Plate, Cranioplasty, Preformed, Alterable

Cleared on Oct 12, 2012 as substantially equivalent to K854886 (Walter Lorenz Surgical, Inc., 1986) and 2 other predicates after a 133-day review. Its family tree reaches back 1 generation to 1986. 5 later devices descend from it. It has been recalled 2 times.

Decided: Oct 12, 2012
Review: 133 days
Class: Class II
Product code: GWO
Recalls: 2
Predicates: 3

Its longest line of descent runs back 1 generation to K854886 (1986). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK854886 Wuerzburg Titanium Mini Bone Plates & Bone ScrewsWalter Lorenz Surgical, Inc. · 1986 · Recalled
This deviceK121624 Biomet Microfixation Neuro Plating SystemBiomet Microfixation · 2012
Descendant · cites it directly · 4 of its ownK141911 Optimus Neuro SystemOsteonic Co., Ltd. · 2015
Descendant · 2 generations on · 2 of its ownK183352 Optimus Neuro SystemOsteonic Co., Ltd. · 2019
Descendant · 2 generations on · 1 of its ownK190811 Optimus NEURO System - Sterile KitOsteonic Co., Ltd. · 2019
Descendant · 2 generations on · 0 of its ownK212391 MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc. · 2022
Descendant · 3 generations on · 0 of its ownK210360 Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61…Osteonic Co., Ltd. · 2022

Most influential descendants

Showing 5 of 5 · See all

K141911Optimus Neuro SystemOsteonic Co., Ltd. · 2015 · cites it directly4descendants
K183352Optimus Neuro SystemOsteonic Co., Ltd. · 2019 · 2 generations on2descendants
K190811Optimus NEURO System - Sterile KitOsteonic Co., Ltd. · 2019 · 2 generations on1descendant
K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc. · 2022 · 2 generations on0descendants
K210360Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models), Neuro…Osteonic Co., Ltd. · 2022 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K854886	Wuerzburg Titanium Mini Bone Plates & Bone Screws	Walter Lorenz Surgical, Inc.	1986	1
0 (this device)	K121624	Biomet Microfixation Neuro Plating System	Biomet Microfixation	2012	—
+1	K141911	Optimus Neuro System	Osteonic Co., Ltd.	2015	—
+2	K183352	Optimus Neuro System	Osteonic Co., Ltd.	2019	—
+2	K190811	Optimus NEURO System - Sterile Kit	Osteonic Co., Ltd.	2019	—
+2	K212391	MCI-Neuro Fixation System	Mci Medical Concept Innovation, Inc.	2022	—
+3	K210360	Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models)…	Osteonic Co., Ltd.	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2019	2	0
2022	2	0

FIG. 1 — Lineage of K121624, 1986–2022Source: 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 GWO? 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 GWO device

#1 K261058 CraniUS Platescore 16.8 · 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? (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
*	K854886	Wuerzburg Titanium Mini Bone Plates & Bone Screws Summary page 2 …o Plating System modifications equivalent to the Biomet Microfixation (formally Walter Lorenz Surgical) Wuerzburg Titanium Mini Bone Plates and Bone Screws cleared under K854886, Lorenz 1.0 MM System cleared under K922741, and Lorenz 1.0mm, 1.5mm, 2.0mm Plating system cleared under K953385. Subject pre-con…	Walter Lorenz Surgical, Inc.	1986	1
*	K922741	Lorenz 1.0 MM System Summary page 2 …the Biomet Microfixation (formally Walter Lorenz Surgical) Wuerzburg Titanium Mini Bone Plates and Bone Screws cleared under K854886, Lorenz 1.0 MM System cleared under K922741, and Lorenz 1.0mm, 1.5mm, 2.0mm Plating system cleared under K953385. Subject pre-contoured mesh are similar to the predicate dev…	Walter Lorenz Surgical, Inc.	1992	—
*	K953385	Lorenz 1.0MM, 1.5MM, 2.0MM System Summary page 2 …Titanium Mini Bone Plates and Bone Screws cleared under K854886, Lorenz 1.0 MM System cleared under K922741, and Lorenz 1.0mm, 1.5mm, 2.0mm Plating system cleared under K953385. Subject pre-contoured mesh are similar to the predicate devices in terms of material, indications, use, sterility, and design.…	Walter Lorenz Surgical, Inc.	1995	8

Also cleared against K854886: 9 other devices →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K141911	Optimus Neuro System	Osteonic Co., Ltd.	2015	4

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 6, 2015	Class II	Z-0136-2016	Component change control	The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
Aug 6, 2015	Class II	Z-0137-2016	Component change control	The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 3 ancestors have a recall of any class.
Of its descendants, K141911 (Osteonic Co., Ltd., 2015) has gone furthest, with 4 descendants of its own.
9 other devices also cite its predicate K854886.

How does its category compare?

All GWO devices

GWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · GWO

2in 2025

2007high 5 (2012) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWO

196in 2019

2007high 249 (2013) · low 109 (2014)2026

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

Recalls per year · GWO

2in 2015

2007high 2 (2015) · low 0 (2008)2026

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

Adverse event reports per year · GWO

237in 2025

2007high 237 (2025) · low 0 (2007)2025

MAUDE reports naming product code GWO, 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	1	—	1	0
2008	1	—	0	3
2009	0	—	0	2
2010	1	—	0	7
2011	2	—	0	1
2012	5	133	0	5
2013	4	249	0	7
2014	3	109	0	11
2015	3	210	2	18
2016	3	125	0	18
2017	2	—	0	47
2018	1	—	0	41
2019	4	196	0	14
2020	0	—	0	25
2021	1	—	0	41
2022	2	—	0	53
2023	0	—	0	72
2024	1	—	0	149
2025	2	—	0	237
2026	2	—	0	—

What is it indicated for?

These devices are implantable bone plates and bone screws for neuro procedures including:

1. Fractures

2. Osteotomies

3. Reconstructive procedures

4. Revision procedures where other treatments or devices have failed

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121624 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121624: Biomet Microfixation Neuro Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121624

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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