# K082516: Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 17, 2008 after 15 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962616 (1996). 30 ancestors in all.
87 later devices descend from it; 8 cite it directly.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity, Smith & Nephew, Inc. (2005) Summary page 1.
- K061352: Peri-Loc Periarticular Locked Plating System for the Upper Extremity, Smith & Nephew, Inc. (2006) Summary page 1.
- 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.
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 1.

## Most influential descendants
- K083032: Peri-Loc Bone Plating and Screw System (2009), 77 descendants of its own
- K132886: Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (2014), 46 descendants of its own
- K100325: Peri-Loc Locking Hole Inserts and Cable Accessories (2010), 38 descendants of its own
- K123055: Smith & Nephew, Inc Screw and Plate System Instrumentation (2013), 33 descendants of its own
- K140814: Evos Mini-Fragment Plating System (2014), 32 descendants of its own

## Indications for use
The PERI-LOC Periarticular Locked Plating System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bones plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, 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/K082516
Methodology: https://510kreport.com/methodology