# K213126: Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 29, 2022 after 367 days
- Product code: JDO (Device, Fixation, Proximal Femoral, Implant)
- 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: 14 generations back to K962616 (1996). 234 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 237 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933027: The Modular Nail, Smith & Nephew Richards, Inc. (1994) Summary page 15.
- K952697: Titanium Classic Compression Hip Screw System, Smith & Nephew Richards, Inc. (1995) Summary page 15.
- K954712: Intramedullary Hip Screw (Modification), Smith & Nephew Richards, Inc. (1995) Summary page 15.
- K993289: Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System, Smith & Nephew, Inc. (1999) Summary page 15.
- K210837: Smith & Nephew Plates and Screws, Smith & Nephew, Inc. (2021) Summary page 15.
- K152686: Conquest FN, Smith & Nephew (2016) Summary page 15.
- K172785: Conquest FN, Smith & Nephew (2017) Summary page 15.
- K193029: Conquest FN, Smith & Nephew, Inc. (2020) Summary page 15.
- K132296: D-Rad Smart Pack, Smith & Nephew, Inc. (2014) Summary page 15.
- K161665: VLP Wrist Fracture System, Smith & Nephew, Inc. (2016) Summary page 15.
- K140814: Evos Mini-Fragment Plating System, Smith & Nephew, Inc. (2014) Summary page 15.
- K162078: EVOS Small Fragment Plating System, Smith & Nephew, Inc. (2016) Summary page 15.
- K170457: EVOS Small Fragment Lower Extremity Plates, Smith & Nephew, Inc. (2017) Summary page 15.
- K170887: EVOS Small Fragment Plating System, Smith & Nephew, Inc. (2017) Summary page 15.
- K173293: EVOS Small Fragment Upper Extremity Plates, Smith & Nephew, Inc. (2018) Summary page 15.
- K181533: EVOS Wrist Fracture Plating System, Smith & Nephew, Inc. (2018) Summary page 15.
- K190253: EVOS Small Fragment Upper Extremity Plates Line Additions, Smith & Nephew, Inc. (2019) Summary page 15.
- K201527: EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm), Smith & Nephew, Inc. (2020) Summary page 15.
- K201918: EVOS Large Fragment Plating System, Smith & Nephew, Inc. (2020) Summary page 15.
- K203405: EVOS Large Fragment Plating System, Smith & Nephew, Inc. (2021) Summary page 15.
- K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws), Smith & Nephew, Inc. (2003) Summary page 15.
- K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity, Smith & Nephew, Inc. (2005) Summary page 15.
- K061352: Peri-Loc Periarticular Locked Plating System for the Upper Extremity, Smith & Nephew, Inc. (2006) Summary page 15.
- K062216: Peri-Loc Periarticular Locked Plating System, Smith & Nephew, Inc. (2006) Summary page 15.
- K071563: Peri-Loc Periarticular Locked Plating System, Smith & Nephew, Inc. (2007) Summary page 15.
- K072818: Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access, Smith & Nephew, Inc. (2007) Summary page 15.
- K080434: Intertan CHS Locking Plate System Prox Fem Plates/Screw, Smith & Nephew, Inc. (2008) Summary page 16.
- K082516: Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws, Smith & Nephew, Inc. (2008) Summary page 16.
- K083032: Peri-Loc Bone Plating and Screw System, Smith & Nephew, Inc. (2009) Summary page 16.
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories, Smith & Nephew, Inc. (2009) Summary page 16.
- K092015: Peri-Loc Periarticular Locked Plating System, Smith & Nephew, Inc. (2009) Summary page 16.
- K100325: Peri-Loc Locking Hole Inserts and Cable Accessories, Smith & Nephew, Inc. (2010) Summary page 16.
- K110670: VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws, Peri-Loc Ankle Fusion Plates, Smith & Nephew, Inc. (2011) Summary page 16.
- K120667: VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion Plates, Peri-Loc 3.5MM Hindfoot, Smith & Nephew, Inc. (2012) Summary page 16.
- K132886: Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System, Smith & Nephew, Inc. (2014) Summary page 16.
- K143050: VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws, Smith & Nephew, Inc. (2014) Summary page 16.
- K152976: VLP Mini-Mod Talus Plates, Smith & Nephew, Inc. (2015) Summary page 16.
- K123055: Smith & Nephew, Inc Screw and Plate System Instrumentation, Smith & Nephew, Inc. (2013) Summary page 16.
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories), Smith & Nephew, Inc. (1999) Summary page 16.
- K060736: Smith & Nephew 6.5MM and 8.0MM Cannulated Screws, Smith & Nephew, Inc. (2006) Summary page 16.
- K111994: Smith & Nephew Cannulated Screws and Washers, Smith & Nephew, Inc. (2011) Summary page 16.
- K133662: Smith & Nephew Cannulated Captured Screw, Smith & Nephew, Inc. (2014) Summary page 16.

## Most influential descendants
- K252019: CurvaFix Low Profile System (2025), 0 descendants of its own
- K233396: Cannulated Screw System (2023), 0 descendants of its own

## Recalls of this device
- Sep 6, 2026 · Not classified · Z-0318-2027: Incorrect labeling; 3.5MM Partial Articular Lateral Proximal Tibia Plate 6 hole Left 91MM implant labeled and lasered etched as as 3.5MM Lateral Proximal Tibia Plate 6 hole left 91mm implant

## Indications for use
The EVOS MINI Plating System is indicated for adolescent (12—18 years) and transitional adolescent (18–21 years) subpopulations and adults, as well as patients with osteopenic bone. The EVOS MINI Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones. The EVOS Small Fragment Plating System is indicated for adult and adolescent (greater than 12-21 years of age) patients, as well as patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle. The EVOS Partial Articular and Anti-Glide Plates are indicated for the treatment of partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classifications Type B), and for fracture fixation of the fibula. The EVOS Wrist Fracture Plating System is indicated for adult and pediatric patients, as well as patients with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna. The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures. The PERI-LOC Plate and Screw System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone plates and bone 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. PERI-LOC Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC contoured VLP Plates and Screws are indicated for partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and proximal tibia, and for fracture fixation of the fibula. PERI-LOC VLP One-Third Tubular Locking Plates are indicated for, but not limited to, fixation of fractures, non-unions and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals. PERI-LOC 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-LOC Proximal Femur 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. The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP FOOT Plating System is indicated for fracture fixation, reconstruction or arthrodeses of small bones, including those in the forefoot, midfoot and hindfoot. The Smith & Nephew PERI-LOC Ankle Fusion Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The PERI-LOC Ankle Fusion Plating System is indicated for ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus. The VLP MINI-MOD Small Bone Plating System and VLP MINI-MOD Talus Plates are indicated for adolescent (12—18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP MINI-MOD Small Bone Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones. The VLP MINI-MOD Talus Plates are indicated for fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot. The VLP Wrist Fracture System Radial Plates are indicated for fixation of fractures, malunions, and osteotomies involving the radius. The D-RAD SMART PACK System is intended for the fixation of fractures involving the distal radius. Bone plates and screws from the Smith & Nephew Bone Plate System are used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation. 1. Intracapsular fractures of the femoral neck. (For high subcapsular fractures it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.) 2. Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity. 3. Osteotomies for patients with diseases or deformities of the hip. 4. Hip arthrodesis. 5. Supracondylar fractures and distal femoral fractures using a supracondylar plate. 6. Ipsilateral femoral shaft/neck fractures. CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures. The 4.0mm Cannulated Screws and associated washers are additionally intended for arthrodesis and osteotomies of small bones and small joints, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated washers are additionally intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle. The Smith & Nephew 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodeses of small joints; bunionectomies and osteotomies; scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The Smith & Nephew 2.0mm QFX Screw is indicated for osteotomies of the lesser metatarsals, such as Weil osteotomies. Osteotomies, fusions and fractures of the phalanges, metacarpals and carpals of the hand.

Source page: https://510kreport.com/device/K213126
Methodology: https://510kreport.com/methodology