# K123055: Smith & Nephew, Inc Screw and Plate System Instrumentation - Pathway: 510(k) (Traditional) - Applicant: Smith & Nephew, Inc. - Decided: Jan 25, 2013 after 116 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). 90 ancestors in all. 33 later devices descend from it; 3 cite it directly. 0 of 124 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K952697: Titanium Classic Compression Hip Screw System, Smith & Nephew Richards, Inc. (1995) Summary page 1. - K973098: Compression Cerclage Gundolf CCG-GF, Plus Orthopedics (1997) Summary page 1. - K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories), Smith & Nephew, Inc. (1999) Summary page 1. - K011719: Plus Cancellous Bone Screws, Plus Orthopedics (2001) Summary page 1. - K050849: HA Coated Lag Screw, Smith & Nephew, Inc. (2005) Summary page 1. - K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity, Smith & Nephew, Inc. (2005) Summary page 1. - K060736: Smith & Nephew 6.5MM and 8.0MM Cannulated Screws, Smith & Nephew, Inc. (2006) Summary page 1. - K061352: Peri-Loc Periarticular Locked Plating System for the Upper Extremity, Smith & Nephew, Inc. (2006) Summary page 1. - K071563: Peri-Loc Periarticular Locked Plating System, Smith & Nephew, Inc. (2007) Summary page 1. - K072818: Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access, Smith & Nephew, Inc. (2007) Summary page 1. - K080434: Intertan CHS Locking Plate System Prox Fem Plates/Screw, Smith & Nephew, Inc. (2008) Summary page 1. - K081106: Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the Upper Extremity-Astm F139, Smith & Nephew, Inc. (2008) Summary page 1. - K082516: Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws, Smith & Nephew, Inc. (2008) Summary page 1. - K083032: Peri-Loc Bone Plating and Screw System, Smith & Nephew, Inc. (2009) Summary page 1. - K090656: Intertan CHS Limited Collapse Set Screw, Smith & Nephew, Inc. (2009) Summary page 1. - K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories, Smith & Nephew, Inc. (2009) Summary page 1. - K092015: Peri-Loc Periarticular Locked Plating System, Smith & Nephew, Inc. (2009) Summary page 1. - K100325: Peri-Loc Locking Hole Inserts and Cable Accessories, Smith & Nephew, Inc. (2010) Summary page 1. ## Cited in the summary but kept off the family tree - K193623: DIOnavi-Denture, Dio Corporation (2020). Our reading of the summary gave K193623, which FDA decided on Oct 22, 2020, after this device was decided (Jan 25, 2013), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 1. - K103669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws). Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree ## Most influential descendants - K140814: Evos Mini-Fragment Plating System (2014), 32 descendants of its own - K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own - K173166: ANTHEM Fracture System (2017), 11 descendants of its own - K180554: ANTHEM Fracture System (2018), 10 descendants of its own - K181533: EVOS Wrist Fracture Plating System (2018), 9 descendants of its own ## Indications for use Smith & Nephew PERI-LOC Locking Bone Plates, Locking Hole Inserts and Cable Accessories Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Periarticular Locked Plating Systems and their cleared indications for use. The PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws, Locking Hole Inserts and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. The PERI-LOC Proximal Femur Locking Bone Plates, Bone Screws, Locking Hole Inserts 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 the 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 * subtrochanteric femur fractures. In addition, the PERI-LOC Periarticular Locked Plating System including Locking Hole Inserts and Cable Accessories can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone 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. Smith & Nephew VLP FOOT Plating System, Screw System and Accessories Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew VLP FOOT Plating System and Screw Systems and their cleared indications for use. 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 Plating System is indicated for: * the treatment of fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot. The Smith & Nephew Screw Systems, containing 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws, are indicated for: * fixation of interarticular and extra-articular fractures and non-unions of small bones and small bone fragments; * arthrodesis 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 OFX 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. Smith & Nephew Accessories, such as pins and wires, are indicated for: * pelvic, small and long bone fracture fixation. Smith & Nephew InterTAN CHS Limited Collapse Set Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew InterTAN CHS Limited Collapse Set Screw Systems and their cleared indications for use. InterTAN CHS Limited Collapse Set Screw is indicated for: * Intracapsular fractures of the proximal femur (For certain high subcapsular fractures, it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of nonunion or AVN of the femoral head). * Intertrochanteric fractures. * Stable and unstable fractures of the proximal femur in which medial cortex stability can be restored. * Hip osteotomy Smith & Nephew VLP Locking Bone Plates and Locking/Non-Locking Bone Screws Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew PERI-LOC Periarticular Locked Plating Systems and their cleared indications for use. 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: * fixation of fractures, non-unions, and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals. Smith & Nephew 6.5mm and 8.0mm Cannulated Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew 6.5mm and 8.0mm Cannulated Screw Systems and their cleared indications for use. Smith & Nephew 6.5mm and 8.0mm Cannulated Screws are indicated for: * fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; * treatment of the calcaneal * hip arthrodesis * provisional bone fixation. Smith & Nephew Bone Plate System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Bone Plate Systems and their cleared indications for use. Smith & Nephew Bone Plates, Bone Screws, and Accessories are indicated for: * pelvic fracture fixation * small bone fracture fixation * long bone fracture fixation. Smith & Nephew Titanium Classic Compression Hip Screw System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Titanium Classic Compression Hip Screw Systems and their cleared indications for use. The Titanium Classic Compression Hip Screw System is indicated for: * Pelvic Radius Plate- general fractures of the pelvis and acetabulum * Tibial Plateau Plate- fractures of the proximal tibia with or without diaphyseal involvement * One Third Tubular Plate- fractures of the fibula, lateral malleolus, metacarpals, metatarsals, olecranon, and distal ulna * Small Auto-Compression Plate- fracture fixation of metatarsals, metacarpals, radius, and ulna * Titanium Cortical Bone Screw- small and long bone fracture fixation Source page: https://510kreport.com/device/K123055 Methodology: https://510kreport.com/methodology