510(k) · Cleared

Cleared

Optilock VL (Variable Angle Locking) Distal Radius Plating System

K093761510(k) TraditionalCleared Mar 5, 201088-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

Biomet Trauma (Aka Ebi, Lp) · HRS Plate, Fixation, Bone

Cleared on Mar 5, 2010 as substantially equivalent to K062494 (Ebi, L.P., 2006) and 7 other predicates after an 88-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.

Decided: Mar 5, 2010
Review: 88 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 8

Its longest line of descent runs back 2 generations to K000684 (2000). 15 ancestors in all. 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
1 generation backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
This deviceK093761 Optilock VL (Variable Angle Locking) Distal Radius Plating SystemBiomet Trauma (Aka Ebi, Lp) · 2010
Descendant · cites it directly · 1 of its ownK150675 Dorsal Spanning PlateSkeletal Dynamics, LLC · 2015
Descendant · 2 generations on · 0 of its ownK212601 DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company · 2022
Descendant · cites it directly · 0 of its ownK110271 Maestro Wrist Plating SystemBiomet Manufacturing Corp · 2011

Most influential descendants

Showing 3 of 3 · See all

K150675Dorsal Spanning PlateSkeletal Dynamics, LLC · 2015 · cites it directly1descendant
K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company · 2022 · 2 generations on0descendants
K110271Maestro Wrist Plating SystemBiomet Manufacturing Corp · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K000684	Small Fragment Dynamic Compression Locking (DCL) System	Synthes (Usa)	2000	1
−1	K011335	Synths One-Third Tubular DCL Plate	Synthes (Usa)	2001	2
0 (this device)	K093761	Optilock VL (Variable Angle Locking) Distal Radius Plating System	Biomet Trauma (Aka Ebi, Lp)	2010	—
+1	K150675	Dorsal Spanning Plate	Skeletal Dynamics, LLC	2015	—
+2	K212601	DRPx Locking Distal Radius Plate System	Orthopaedic Implant Company	2022	—
+1	K110271	Maestro Wrist Plating System	Biomet Manufacturing Corp	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	2	0
2001	1	0
2002	1	0
2004	3	0
2005	2	0
2006	2	0
2007	1	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2015	1	0
2022	1	0

FIG. 1 — Lineage of K093761, 2000–2022Source: 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 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? (8)

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
*	K062494	Ebi Optilock Upper Extremity Plating System Summary page 2 …characteristics, and principles of operation and does not present any new issues of safety or effectiveness. Examples of predicates include: OptiLock® UE Plating System (K062494); FBI Distal Radius Plating System (K040908); IQL Basic Fragment Plate Set (K020221); Synthes Distal Radius Plating Systems (KO1…	Ebi, L.P.	2006	1
*	K040908	Ebi Distal Radius Plating System Summary page 2 …and does not present any new issues of safety or effectiveness. Examples of predicates include: OptiLock® UE Plating System (K062494); FBI Distal Radius Plating System (K040908); IQL Basic Fragment Plate Set (K020221); Synthes Distal Radius Plating Systems (KO1 1335, K071 184 and K083694) and Stryker Vari…	Ebi, L.P.	2004	—
*	K020221	Iql Basic Fragment Plate Set, Iql Basic Fragment Screw Set, Iql Small Fragment Set, Iql… Summary page 2 …safety or effectiveness. Examples of predicates include: OptiLock® UE Plating System (K062494); FBI Distal Radius Plating System (K040908); IQL Basic Fragment Plate Set (K020221); Synthes Distal Radius Plating Systems (KO1 1335, K071 184 and K083694) and Stryker VariAx Distal Radius System (K050512 and K06…	Biomet Orthopedics, Inc.	2002	—
*	K011335	Synths One-Third Tubular DCL Plate	Synthes (Usa)	2001	2
*	K071184	Synthes (Usa) Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius System Summary page 2 …tiLock® UE Plating System (K062494); FBI Distal Radius Plating System (K040908); IQL Basic Fragment Plate Set (K020221); Synthes Distal Radius Plating Systems (KO1 1335, K071 184 and K083694) and Stryker VariAx Distal Radius System (K050512 and K0605 14). Based upon the engineering analysis, the OptiLock® V…	Synthes (Usa)	2007	1
*	K083694	Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius Plates Summary page 2 …ating System (K062494); FBI Distal Radius Plating System (K040908); IQL Basic Fragment Plate Set (K020221); Synthes Distal Radius Plating Systems (KO1 1335, K071 184 and K083694) and Stryker VariAx Distal Radius System (K050512 and K0605 14). Based upon the engineering analysis, the OptiLock® VL Distal Rad…	Synthes (Usa)	2009	2
*	K050512	Stryker Locked Plating System Summary page 2 …System (K040908); IQL Basic Fragment Plate Set (K020221); Synthes Distal Radius Plating Systems (KO1 1335, K071 184 and K083694) and Stryker VariAx Distal Radius System (K050512 and K0605 14). Based upon the engineering analysis, the OptiLock® VL Distal Radius Plating System is substantially equivalent for…	Howmedica Osteonics Corp.	2005	—
*	K060514	Stryker Plating System Summary page 2 …908); IQL Basic Fragment Plate Set (K020221); Synthes Distal Radius Plating Systems (KO1 1335, K071 184 and K083694) and Stryker VariAx Distal Radius System (K050512 and K0605 14). Based upon the engineering analysis, the OptiLock® VL Distal Radius Plating System is substantially equivalent for its intended…	Howmedica Osteonics Corp.	2006	—

Also cleared against K062494: 3 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K150675	Dorsal Spanning Plate	Skeletal Dynamics, LLC	2015	1
K110271	Maestro Wrist Plating System	Biomet Manufacturing Corp	2011	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?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
6 of the 15 ancestors have a recall of any class.
Of its descendants, K150675 (Skeletal Dynamics, LLC, 2015) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K062494.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

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® VL Distal Radius Plating System consists of a series of plates and screws that are intended for the fixation of intra-articular and extra-articular fractures involving the distal radius, ulna (and other small bones). This system is also intended for use in osteopenic bone. Specific indications include:

1. Fixation of intra-articular and extra-articular fractures

2. Treatment of mal-unions

3. Treatment of non-unions

4. Osteotomies

5. Wrist arthrodesis

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093761 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093761: Optilock VL (Variable Angle Locking) Distal Radius 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/K093761

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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