510(k) · Cleared

Recalled · 2012

Ebi Optilock Upper Extremity Plating System

K062494510(k) TraditionalCleared Oct 19, 200655-day reviewClass II21 CFR 888.3030Recalls 1

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

Ebi, L.P. · HRS Plate, Fixation, Bone

Cleared on Oct 19, 2006 as substantially equivalent to K000684 (Synthes (Usa), 2000) and 4 other predicates after a 55-day review. Its family tree reaches back 1 generation to 2000. 22 later devices descend from it. It has been recalled once.

Decided: Oct 19, 2006
Review: 55 days
Class: Class II
Product code: HRS
Recalls: 1
Predicates: 5

Its longest line of descent runs back 1 generation to K000684 (2000). 5 ancestors in all. 22 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
This deviceK062494 Ebi Optilock Upper Extremity Plating SystemEbi, L.P. · 2006
Descendant · cites it directly · 15 of its ownK153716 GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating…Gpc Medical, Ltd. · 2016
Descendant · 2 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
Descendant · 3 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
Descendant · 3 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
Descendant · 3 generations on · 8 of its ownK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2010high 4 (2024) · low 0 (2012)2026

Most influential descendants

Showing 5 of 22 · See all

K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd. · 2016 · cites it directly15descendants
K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on14descendants
K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on11descendants
K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 3 generations on10descendants
K202496ANTHEM Fracture SystemGlobus Medical, Inc. · 2020 · 3 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000684	Small Fragment Dynamic Compression Locking (DCL) System	Synthes (Usa)	2000	1
0 (this device)	K062494	Ebi Optilock Upper Extremity Plating System	Ebi, L.P.	2006	—
+1	K153716	GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.	Gpc Medical, Ltd.	2016	—
+2	K163361	ANTHEM™ Fracture System	Globus Medical, Inc.	2017	—
+3	K173166	ANTHEM Fracture System	Globus Medical, Inc.	2017	—
+3	K180554	ANTHEM Fracture System	Globus Medical, Inc.	2018	—
+3	K202496	ANTHEM Fracture System	Globus Medical, Inc.	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2004	2	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	3	0
2015	1	0
2016	1	0
2017	2	0
2018	2	0
2020	1	0
2021	1	0
2022	2	0
2023	1	0
2024	4	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K062494, 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? (5)

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
*	K000684	Small Fragment Dynamic Compression Locking (DCL) System Summary page 1 …cate or legally marketed devices that are substantially equivalent: [ Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684) oi Synthes LCP Proximal Humerus Plate (KO I1815) o Synthes LCP Proximal Humerus Plate, Long (K041…	Synthes (Usa)	2000	1
*	K011815	Synthes LCP Proximal Humerus Plates	Synthes (Usa)	2001	—
*	K041860	Synthes (Usa) LCP Proximal Humerus Plates, Long Summary page 1 …king (DCL) System (K000684) oi Synthes LCP Proximal Humerus Plate (KO I1815) o Synthes LCP Proximal Humerus Plate, Long (K041860) o Synthes 3.5 mm LCP Distal Humerus System (K033995) o Synthes 3.5 mm Cortex Screws (K043185) 6…	Synthes (Usa)	2004	—
*	K033995	3.5 MM LCP Distal Humerus System Summary page 1 …es LCP Proximal Humerus Plate (KO I1815) o Synthes LCP Proximal Humerus Plate, Long (K041860) o Synthes 3.5 mm LCP Distal Humerus System (K033995) o Synthes 3.5 mm Cortex Screws (K043185) 6. Description of the device: The EBI OptiLock Upper Extremity Platin…	Synthes (Usa)	2004	1
*	K043185	Synthes 3.5MM Cortex Screws Summary page 1 …Synthes LCP Proximal Humerus Plate, Long (K041860) o Synthes 3.5 mm LCP Distal Humerus System (K033995) o Synthes 3.5 mm Cortex Screws (K043185) 6. Description of the device: The EBI OptiLock Upper Extremity Plating System is an internal fixation device used to provide…	Synthes (Usa)	2005	—

Also cleared against K000684: 68 other devices →

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K153716	GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.	Gpc Medical, Ltd.	2016	15
K093761	Optilock VL (Variable Angle Locking) Distal Radius Plating System	Biomet Trauma (Aka Ebi, Lp)	2010	3
K110201	Explor Radial Head Plating System	Biomet, Inc.	2011	0
K110320	Comprehensiveproximal Humeral Plating System	Biomet Manufacturing Corp	2011	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 15, 2012	Not classified	Z-1439-2012	Labeling mix-ups	Biomet initiated this action after a complaint was received that item 36728, Non-Locking Screw 3.5mm x 28mm was in a package labeled as 37728, Locking Screw 3.5mm x 28mm.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 5 ancestors have a recall of any class.
Of its descendants, K153716 (Gpc Medical, Ltd., 2016) has gone furthest, with 15 descendants of its own.
68 other devices also cite its predicate K000684.

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 OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies.

The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.

The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062494 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062494: Ebi Optilock Upper Extremity Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062494

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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