# K062216: Peri-Loc Periarticular Locked Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 15, 2006 after 45 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981372 (1998). 9 ancestors in all.
501 later devices descend from it; 6 cite it directly.
1 of 511 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws), Smith & Nephew, Inc. (2003) Summary page 1.
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories), Smith & Nephew, Inc. (1999) Summary page 1.

## Most influential descendants
- K071563: Peri-Loc Periarticular Locked Plating System (2007), 495 descendants of its own
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories (2009), 487 descendants of its own
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System (2010), 228 descendants of its own
- K111994: Smith & Nephew Cannulated Screws and Washers (2011), 161 descendants of its own
- K112583: Synthes Cortical Screws (2011), 118 descendants of its own

## Recalls of this device
- Mar 9, 2017 · Class II · Z-1854-2017: The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.

## Indications for use
PERI-LOC Periarticular Locked Plating System B-Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC contoured B-Plates and Screws are indicated for partial articular fractures of the distal fibula, distal tibia, and proximal tibia. PERI-LOC Locking Tubular Plates are indicated for fracture fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle. Components in the PERI-LOC Periarticular Locked Plating System are for single use only.

Source page: https://510kreport.com/device/K062216
Methodology: https://510kreport.com/methodology