510(k) · Cleared

Cleared

Ebi Optilock Periarticular Plating System

K061098510(k) TraditionalCleared May 24, 200635-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

Ebi, L.P. · HRS Plate, Fixation, Bone

Cleared on May 24, 2006 after a 35-day review. The FDA summary names its predicate without a number. 57 later devices descend from it.

Decided: May 24, 2006
Review: 35 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 0

57 later devices descend from it, 3 citing it directly.

This deviceK061098 Ebi Optilock Periarticular Plating SystemEbi, L.P. · 2006
Descendant · cites it directly · 52 of its ownK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
Descendant · 2 generations on · 39 of its ownK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
Descendant · 3 generations on · 38 of its ownK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
Descendant · 4 generations on · 32 of its ownK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
Descendant · 2 generations on · 25 of its ownK153379 AxSOS 3TiStryker GmbH · 2016

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

2009high 9 (2023) · low 0 (2011)2026

Most influential descendants

Showing 5 of 57 · See all

K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012 · cites it directly52descendants
K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012 · 2 generations on39descendants
K123203Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012 · 3 generations on38descendants
K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013 · 4 generations on32descendants
K153379AxSOS 3TiStryker GmbH · 2016 · 2 generations on25descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K061098	Ebi Optilock Periarticular Plating System	Ebi, L.P.	2006	—
+1	K113048	Maxlock Extreme System	Orthohelix Surgical Designs, Inc.	2012	—
+2	K122005	Maxlock Extreme System	Orthohelix Surgical Designs, Inc.	2012	—
+3	K123203	Maxlock Extreme System Model MXL	Orthohelix Surgical Designs, Inc.	2012	—
+4	K132591	Maxlock Extreme System	Orthohelix Surgical Designs, Inc.	2013	—
+2	K153379	AxSOS 3Ti	Stryker GmbH	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	1	0
2012	3	0
2013	1	0
2014	5	0
2015	3	0
2016	3	0
2017	3	0
2018	3	0
2019	1	0
2020	3	0
2021	2	0
2022	4	0
2023	9	0
2024	5	0
2025	5	0
2026	5	0

FIG. 1 — Lineage of K061098, 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 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? (1)

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
*	—	EBI® Periarticular Plating System Named without a submission number			—

What descends from it? (57)

See all 57

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

Number	Device	Applicant	Decided	Descendants
K113048	Maxlock Extreme System	Orthohelix Surgical Designs, Inc.	2012	52
K092078	Optilock Periarticular Plating	Biomet Trauma	2009	2
K093983	Smple Plate and Screws	Biomet Trauma (Aka Ebi, Lp)	2010	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?

Of its descendants, K113048 (Orthohelix Surgical Designs, Inc., 2012) has gone furthest, with 52 descendants of its own.

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 EBI® OptiLock® Periarticular Plating System (The System) is indicated for the fixation of fractures and osteotomies involving the femur or tibia. The System is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and nonunions and malunions. The System is intended for the treatment of nonunions, malunions and fractures of…

Read the full statement (180 words)

The EBI® OptiLock® Periarticular Plating System (The System) is indicated for the fixation of fractures and osteotomies involving the femur or tibia.

The System is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and nonunions and malunions.

The System is intended for the treatment of nonunions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures.

The System is intended to buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibial shaft.

The System is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061098 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061098: Ebi Optilock Periarticular Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061098

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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