# K140357: Oic Variable Angle Small Fragment Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopaedic Implant Company
- Decided: Jun 9, 2014 after 117 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: 10 generations back to K962616 (1996). 50 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011170: Synthes 2.7 MM LC-DCP, 3.5 MM Profile, Synthes (Usa) (2001). Our reading of the summary gave K001170, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Synthes 2.7mm LC-DCP, 3.5mm Profile (Limited Contact - Dynamic…”.
- K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws), Smith & Nephew, Inc. (2003) Summary page 2.
- K050646: Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates, Synthes (Usa) (2005) Summary page 2.
- K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity, Smith & Nephew, Inc. (2005) Summary page 2.
- K061352: Peri-Loc Periarticular Locked Plating System for the Upper Extremity, Smith & Nephew, Inc. (2006) Summary page 2.
- K071184: Synthes (Usa) Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius System, Synthes (Usa) (2007) Summary page 2.
- K071563: Peri-Loc Periarticular Locked Plating System, Smith & Nephew, Inc. (2007) Summary page 2.
- K071715: Acumed Congruent Bone Plate System, Acumed, LLC (2007) Summary page 2.
- K080522: Synthes 3.5 MM LCP Distal Tibia T Plates, Synthes (Usa) (2008) Summary page 2.
- K083032: Peri-Loc Bone Plating and Screw System, Smith & Nephew, Inc. (2009) Summary page 2.
- K123832: Oic Distal Radius Plating System, Oic Proximal Humerus Plating System, Oic Clavicle Plating System, the Oic Small Fragme, The Orthopaedic Implant Company (Oic) (2013) Summary page 2.

## Most influential descendants
- K223118: OIC Variable Angle Small Fragment Locking Plate System (2023), 1 descendant of its own
- K242995: OIC Small / Mini Fragment Plate System (2024), 0 descendants of its own

## Indications for use
The OIC Variable Angle Small Fragment Locking Plate System is indicated for the fixation of fractures, mal-unions, non-unions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.

Source page: https://510kreport.com/device/K140357
Methodology: https://510kreport.com/methodology