# K232652: Anatomical Plating System (various) - Pathway: 510(k) (Traditional) - Applicant: Tyber Medical, LLC - Decided: Dec 13, 2023 after 104 days - Product code: HRS (Plate, Fixation, Bone) - Device class: 2 - Regulation: 21 CFR 888.3030 - Recalls of this device: 20 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 18 generations back to K962616 (1996). 410 ancestors in all. 3 later devices descend from it; 2 cite it directly. 0 of 414 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K222465: Tyber Medical Anatomical Plating System, Tyber Medical, LLC (2023) Summary page 5. - K203817: Tyber Medical Anatomical Plating System, Tyber Medical, LLC (2021) Summary page 5. - K193222: Tyber Medical Anatomical Plating System, Tyber Medical, LLC (2020) Summary page 5. - K213591: ANTHEM® Fracture System, Globus Medical, Inc. (2022) Summary page 5. ## Most influential descendants - K241218: Tyber Medical Anatomical Plating System (2024), 2 descendants of its own - K242486: Tyber Medical Anatomical Plating System (2025), 1 descendant of its own - K261207: Exalta Proximal Tibia Plating System (2026), 0 descendants of its own ## Recalls of this device - Dec 19, 2025 · Class II · Z-1132-2026: The supplier manufactured anatomical left plates with an incorrect thread orientation. - Dec 19, 2025 · Class II · Z-1131-2026: The supplier manufactured anatomical left plates with an incorrect thread orientation. - Jan 21, 2025 · Class II · Z-1214-2025: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported - Jan 21, 2025 · Class II · Z-1220-2025: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported - Jan 21, 2025 · Class II · Z-1211-2025: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported - Jan 21, 2025 · Class II · Z-1225-2025: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported - Jan 21, 2025 · Class II · Z-1218-2025: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported - Jan 21, 2025 · Class II · Z-1212-2025: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported - Jan 21, 2025 · Class II · Z-1210-2025: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported - Jan 21, 2025 · Class II · Z-1217-2025: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported - Jan 21, 2025 · Class II · Z-1209-2025: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported - Jan 21, 2025 · Class II · Z-1222-2025: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported - Jan 21, 2025 · Class II · Z-1216-2025: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported - Jan 21, 2025 · Class II · Z-1219-2025: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported - Jan 21, 2025 · Class II · Z-1224-2025: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported - Jan 21, 2025 · Class II · Z-1226-2025: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported - Jan 21, 2025 · Class II · Z-1221-2025: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported - Jan 21, 2025 · Class II · Z-1215-2025: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported - Jan 21, 2025 · Class II · Z-1223-2025: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported - Jan 21, 2025 · Class II · Z-1213-2025: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported ## Indications for use The Tyber Medical Anatomical Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the Mini-Frag System, Foot System, Long Bone Fracture System, and Ankle Fracture/ Fusion System with the following indications: Mini-Frag System The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, nonunions, malunions, replantations, and fusions of short bones and small fragments of bone including, but not limited to, the hand, wrist, foot, and ankle. The mini-frag system is also intended for reduction and stabilization of non-load bearing long bone fragments. The Tyber Medical Mini-frag System is not for Spinal Use. Foot System The Tyber Medical Foot System is indicated for fixation of fractures, osteotomies, nonunions, malunions, replantations, and fusions of short bones and small fragments of bone in the foot (Phalanges and Metatarsals), and long bones and long bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) in an adult patient. The Tyber Medical Foot System is not for Spinal Use. Long Bone Fracture System The Tyber Medical Long Bone Fracture System is indicated for fixation of fractures, osteotomies, nonunions, malunions, replantations, and fusions of the clavicle, scapula, olecranon, humerus, radius, ulna, fibula. The Tyber Medical Long Bone Fracture System is not for Spinal Use. Ankle Fracture/Fusion System Tyber Medical Ankle Fracture/Fusion System is indicated for use in: • Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, periarticular fractures, corrective osteotomies, nonunions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures; • In intra- and extra articular fractures, osteotomies, medial malleolar fractures and nonunions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus; • In distal tibia/fibula long bones which include the metaphyseal and diaphyseal regions of the tibia and fibula in the ankle. The Tyber Medical Ankle Fracture/Fusion Plating System is not for Spinal Use. Source page: https://510kreport.com/device/K232652 Methodology: https://510kreport.com/methodology