# K171320: ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws - Pathway: 510(k) (Traditional) - Applicant: Meril Healthcare Pvt., Ltd. - Decided: Mar 8, 2018 after 308 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: 14 generations back to K962616 (1996). 141 ancestors in all. 2 later devices descend from it; 2 cite it directly. 0 of 144 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K143331: Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS, Zimmer, Inc. (2015) Summary page 12. - K083654: Zimmer Universal Locking System 2.7 MM Locking Plates and Screws ( Tivanium TI-6A1-4V Alloy, CP Grade Titanium), Zimmer, Inc. (2009) Summary page 12. - K121672: Aft Proximal Humerus Fracture Plate, Shoulder Options, Inc. (2012) Summary page 12. - K120717: Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates), Synthes USA (2012) Summary page 12. - K082625: Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus Plates, Synthes (Usa) (2008) Summary page 12. - K121601: Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plate, Synthes USA (2012) Summary page 12. - K120854: Synthes VA LCP Ankle Trauma System, Synthes USA (2012) Summary page 12. - K110125: 2.4 MM VA-LCP Volar Rim Distal Radius System, Synthes USA (2011) Summary page 12. - K102694: 2.4MM VA-LCP Dorsal Distal Radius Plates, Synthes (Usa) (2010) Summary page 12. - K953644: Volar Distal Radius Plate, Synthes (Usa) (1996) Summary page 12. - K061753: Synthes (Usa) Clavicle Hook Plates, Synthes (Usa) (2006) Summary page 12. - K070946: Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius Plates, Synthes (Usa) (2007) Summary page 13. - K031573: Synthes 3.5 MM Low Profile Pelvic Reconstruction Plate, Synthes (Usa) (2003) Summary page 13. - K020401: Synthes Calcaneal Plate, Synthes (Usa) (2002) Summary page 13. - K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 13. - K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 13. - K071264: Synthes (Usa) 2.4/2.7 MM Locking Foot Module, Synthes (Usa) (2007) Summary page 13. - K092609: Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP), Synthes (Usa) (2009) Summary page 13. - K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 13. ## Most influential descendants - K241599: Signature Osteosynthesis Plate System (2025), 0 descendants of its own - K200701: Skeletal Dynamics Midshaft Humerus Plating System (2020), 0 descendants of its own ## Indications for use ARMAR™ / ARTIS™ Small Fragment and Calcaneal Plates & MBOSS™/FIXION™ Screws are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as: • comminuted fractures • supracondylar fractures • extra-articular fractures • fractures in osteopenic bone • nonunions • malunions Smaller-sized ARMAR™ / ARTIS™ plates are used for small bones and small fragments of the hands and feet. ARMAR™ / ARTIS™ Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneous. ARMAR™ / ARTIS™ Humerus and Olecranon plates & MBOSS™/FIXION™ Screws are intended for fractures and fracture dislocations, osteotomnies, and non-unions of the distal and proximal humerus, olecranon, and ulna in adult, particularly in osteopenic bone. Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distalhumerus. Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna. ARMAR™ / ARTIS™ Tibia and Buttress Plates & MBOSS™/FIXION™ Screws are intended for fixation of the ankle in adults. Specifically, • Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia. • Medial Distal and Proximal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia, • L Buttress and T Buttress Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and • Proximal Lateral Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia, a Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia. ARMAR™ / ARTIS™ 2.4mm Plates & MBOSS™/FIXION™ Screws are intended for Fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults. ARMAR™ / ARTIS™ Clavical Hook Plate & MBOSS™/FIXION™ Screws is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. ARMAR™ / ARTIS™ Metaphyseal Plate & MBOSS™/FIXION™ Screws indicated for fractures, osteotomies, and non-unions of the radius and other small bones. Additionally, the Metaphyseal Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula. ARMAR™ / ARTIS™ Calcaneal Plate & MBOSS™/FIXION™ Screws is intended for fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus. Source page: https://510kreport.com/device/K171320 Methodology: https://510kreport.com/methodology