510(k) · Cleared

Cleared

The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery

K021684510(k) TraditionalCleared Jun 26, 200235-day reviewClass II21 CFR 872.4760

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

Cleared on Jun 26, 2002 as substantially equivalent to K854886 (Walter Lorenz Surgical, Inc., 1986) and 11 other predicates after a 35-day review. Its family tree reaches back 1 generation to 1986. 7 later devices descend from it.

Decided: Jun 26, 2002
Review: 35 days
Class: Class II
Product code: JEY
Recalls: None
Predicates: 12

Its longest line of descent runs back 1 generation to K854886 (1986). 12 ancestors in all. 7 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK854886 Wuerzburg Titanium Mini Bone Plates & Bone ScrewsWalter Lorenz Surgical, Inc. · 1986 · Recalled
This deviceK021684 The Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc. · 2002
Descendant · cites it directly · 3 of its ownK062819 Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2006
Descendant · 2 generations on · 2 of its ownK073006 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
Descendant · cites it directly · 1 of its ownK023810 Modification to Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc. · 2002
Descendant · 3 generations on · 0 of its ownK121606 Resorb-X GKLS-Martin L.P. · 2013
Descendant · 3 generations on · 0 of its ownK101835 Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2002high 1 (2002) · low 0 (2004)2026

Most influential descendants

Showing 5 of 7 · See all

K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2006 · cites it directly3descendants
K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008 · 2 generations on2descendants
K023810Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…Bioplate, Inc. · 2002 · cites it directly1descendant
K121606Resorb-X GKLS-Martin L.P. · 2013 · 3 generations on0descendants
K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010 · 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)	K021684	The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery	Bioplate, Inc.	2002	—
+1	K062819	Bioplate Rigid Bone Plating System for Craniomaxillofacial Surgery	Bioplate, Inc.	2006	—
+2	K073006	Osteotrans -MX Bioabsorbable Bone Fixation System	Takiron Co., Ltd.	2008	—
+1	K023810	Modification to Bioplate Rigid Fixation Bone Plating System for…	Bioplate, Inc.	2002	—
+3	K121606	Resorb-X G	KLS-Martin L.P.	2013	—
+3	K101835	Medpor Fixation System-Cranial, Models 80080, 80079	Porex Surgical, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	2	0
1992	2	0
1993	1	0
1994	3	0
1995	1	0
1997	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2005	1	0
2006	1	0
2008	1	0
2010	1	0
2013	1	0

FIG. 1 — Lineage of K021684, 1986–2013Source: 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 JEY? 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 JEY device

#1 K252246 Leforte MMF Systemscore 15.6 · 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? (12)

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 1 …Bone Plate (21 CFR 872.4760) Predicate Devices Walter Lorenz Surgical Instruments, Inc. Wurzburg Titanium Mini Bone Plates and Bone Screws K854886 Synthes (USA) Maxillofacial Titanium Micro Set K912932 TiMesh Inc. Softplates and sc…	Walter Lorenz Surgical, Inc.	1986	1
*	K912932	Synthes Maxillofacial Titanium Micro Set Summary page 1 …Instruments, Inc. Wurzburg Titanium Mini Bone Plates and Bone Screws K854886 Synthes (USA) Maxillofacial Titanium Micro Set K912932 TiMesh Inc. Softplates and screws K923419, K923802, K973145 Techmedica, Inc. Anspach…	Synthes (Usa)	1991	—
*	K923419	Tismesh System Summary page 1 …ne Screws K854886 Synthes (USA) Maxillofacial Titanium Micro Set K912932 TiMesh Inc. Softplates and screws K923419, K923802, K973145 Techmedica, Inc. Anspach Fixation System K921801 Walter Lorenz Surgical Ins…	Ti-Mesh, Inc.	1993	—
*	K923802	Timesh Titanium Mini-Softplate/Screw Summary page 1 …K854886 Synthes (USA) Maxillofacial Titanium Micro Set K912932 TiMesh Inc. Softplates and screws K923419, K923802, K973145 Techmedica, Inc. Anspach Fixation System K921801 Walter Lorenz Surgical Instruments,…	Ti-Mesh, Inc.	1992	—
*	K973145	Timesh Titanium Mini-Softplate and Micro-Soft Plate/Screw System Summary page 1 …K854886 Synthes (USA) Maxillofacial Titanium Micro Set K912932 TiMesh Inc. Softplates and screws K923419, K923802, K973145 Techmedica, Inc. Anspach Fixation System K921801 Walter Lorenz Surgical Instruments, Inc.…	Sofamor Danek USA,Inc.	1997	—
*	K921801	Modification Techmedica MP (Miniplating) System Summary page 1 …K912932 TiMesh Inc. Softplates and screws K923419, K923802, K973145 Techmedica, Inc. Anspach Fixation System K921801 Walter Lorenz Surgical Instruments, Inc. Ultra-microTitanium Cranial Osteosynthesis System K910038…	Techmedica, Inc.	1992	—
*	K910038	Lorenz Ultra-Micro Titanium Osteosynthesis System Summary page 1 …. Anspach Fixation System K921801 Walter Lorenz Surgical Instruments, Inc. Ultra-microTitanium Cranial Osteosynthesis System K910038 KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.Omm) L944561 (7) KLS-Marti…	Walter Lorenz Surgical, Inc.	1991	—
*	K944561	Micro Osteosynthesis System (1.0) Summary page 1 …c. Ultra-microTitanium Cranial Osteosynthesis System K910038 KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.Omm) L944561 (7) KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.5mm) K944545 (8) KLS-Martin L.P.…	KLS-Martin L.P.	1994	—
*	K944565	KLS-Martin Micro Osteosythesis System (1.5MM) Our reading of the summary gave K944545, FDA’s number for Body Fluids Barrier Kit (Ani Safety, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “KLS-Martin Micro Osteosynthesis System (1.5mm)”.	KLS-Martin L.P.	1994	—
*	K943347	KLS Mini Osteosynthesis System Summary page 2 …2 === (7) KLS-Martin L.P. KLS-Martin Micro Osteosynthesis System (1.5mm) K944545 (8) KLS-Martin L.P. KLS-Martin Osteosynthesis System (2.0mm) K943347 (9) Sofamor Danek Timesh System K974017 (10) Howmedica, Inc. Luhr Titanium Pan Fixation System K945139 Descri…	Patton, Boggs & Blow	1994	—
*	K974017	Timesh System Summary page 2 …ro Osteosynthesis System (1.5mm) K944545 (8) KLS-Martin L.P. KLS-Martin Osteosynthesis System (2.0mm) K943347 (9) Sofamor Danek Timesh System K974017 (10) Howmedica, Inc. Luhr Titanium Pan Fixation System K945139 Description of the device Modified plate designs for u…	Sofamor Danek USA,Inc.	1998	1
*	K945139	Luhr Titanium Pan Fixation System Summary page 2 …KLS-Martin Osteosynthesis System (2.0mm) K943347 (9) Sofamor Danek Timesh System K974017 (10) Howmedica, Inc. Luhr Titanium Pan Fixation System K945139 Description of the device Modified plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofa…	Howmedica Corp.	1995	—

Also cleared against K854886: 9 other devices →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K062819	Bioplate Rigid Bone Plating System for Craniomaxillofacial Surgery	Bioplate, Inc.	2006	3
K023810	Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…	Bioplate, Inc.	2002	1
K051293	Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation System	Ceremed, Inc.	2005	0
K031028	The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery	Bioplate, Inc.	2003	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?

2 of the 12 ancestors have a recall of any class.
Of its descendants, K062819 (Bioplate, Inc., 2006) has gone furthest, with 3 descendants of its own.
9 other devices also cite its predicate K854886.

How does its category compare?

All JEY devices

JEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JEY

2in 2025

2007high 10 (2012) · low 1 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JEY

159in 2024

2007high 299 (2021) · low 75 (2011)2026

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

Recalls per year · JEY

1in 2020

2007high 85 (2010) · low 0 (2007)2026

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

Adverse event reports per year · JEY

1,003in 2025

2007high 1,003 (2025) · low 24 (2008)2025

MAUDE reports naming product code JEY, 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	9	115	0	29
2008	7	84	3	24
2009	4	121	6	93
2010	6	199	85	215
2011	5	75	0	241
2012	10	194	0	428
2013	8	126	1	766
2014	6	223	0	616
2015	7	160	0	767
2016	1	—	0	558
2017	5	190	0	568
2018	7	255	0	608
2019	6	163	0	595
2020	6	198	1	680
2021	4	299	0	451
2022	5	135	0	344
2023	2	—	0	495
2024	5	159	0	696
2025	2	—	0	1,003
2026	3	258	0	—

What is it indicated for?

The modified plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including cranial bone fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021684 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021684: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021684

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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