# K093761: Optilock VL (Variable Angle Locking) Distal Radius Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Trauma (Aka Ebi, Lp)
- Decided: Mar 5, 2010 after 88 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000684 (2000). 15 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062494: Ebi Optilock Upper Extremity Plating System, Ebi, L.P. (2006) Summary page 2.
- K040908: Ebi Distal Radius Plating System, Ebi, L.P. (2004) Summary page 2.
- K020221: Iql Basic Fragment Plate Set, Iql Basic Fragment Screw Set, Iql Small Fragment Set, Iql Mini Fragment Set, Biomet Orthopedics, Inc. (2002) Summary page 2.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001)
- K071184: Synthes (Usa) Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius System, Synthes (Usa) (2007) Summary page 2.
- K083694: Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius Plates, Synthes (Usa) (2009) Summary page 2.
- K050512: Stryker Locked Plating System, Howmedica Osteonics Corp. (2005) Summary page 2.
- K060514: Stryker Plating System, Howmedica Osteonics Corp. (2006) Summary page 2.

## Most influential descendants
- K150675: Dorsal Spanning Plate (2015), 1 descendant of its own
- K212601: DRPx Locking Distal Radius Plate System (2022), 0 descendants of its own
- K110271: Maestro Wrist Plating System (2011), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K093761
Methodology: https://510kreport.com/methodology