# K112406: Peri-Loc Proximal Femur Locking Bone Plates

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 14, 2011 after 84 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: 4 generations back to K981372 (1998). 17 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072818: Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access, Smith & Nephew, Inc. (2007) Summary page 1.
- K993289: Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System, Smith & Nephew, Inc. (1999) Summary page 2.

## Most influential descendants
- K182154: Depuy Synthes Femoral Neck System (2018), 1 descendant of its own
- K232115: TDM Large Bone Plate and Screw System (2024), 0 descendants of its own
- K230764: OsteoCentric Integrated Hip Fastener System (2023), 0 descendants of its own

## Indications for use
PERI-LO CTM Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LO CTM Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures. Components in the PERI-LOCTM Periarticular Locked Plating System - Proximal Femur Locking Bone Plates are for single use only.

Source page: https://510kreport.com/device/K112406
Methodology: https://510kreport.com/methodology