# K121601: Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes USA
- Decided: Jul 6, 2012 after 35 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: 13 generations back to K962616 (1996). 104 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120854: Synthes VA LCP Ankle Trauma System, Synthes USA (2012). Cleared while this submission was under review Summary page 1.
- K033805: Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal Plates, Synthes (Usa) (2004) Summary page 1.
- K040593: Periarticular Locking Plates and Screws, 2358, 2359 Series, Zimmer, Inc. (2004) Summary page 1.
- K042598: Periarticular Locking Plates and Screws, 2357 and 2359 Series, Zimmer, Inc. (2004) Summary page 1.
- K043227: Periarticular Locking Plates, 2358 Series, Zimmer, Inc. (2004) Summary page 1.
- K043560: Periarticular Locking Plates and Screws, Series 2358 and 2359, Zimmer, Inc. (2005) Summary page 1.
- K050121: Zimmer Periarticular Locking Plate System, Model 2357 & 2359, Zimmer, Inc. (2005). Our reading of the summary gave K030121, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Zimmer Periarticular and ECT Plate Systems”.
- K051098: Periarticular Locking Plates and Screws, Model 2358 Series, Zimmer, Inc. (2005) Summary page 1.
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011)
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 1.
- K110354: 4.5MM VA-LCP Curved Condylar Plate System, Synthes USA (2011)

## Most influential descendants
- 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 (2018), 2 descendants of its own
- K241599: Signature Osteosynthesis Plate System (2025), 0 descendants of its own
- K200062: Foot and Ankle System (2021), 0 descendants of its own
- K200701: Skeletal Dynamics Midshaft Humerus Plating System (2020), 0 descendants of its own
- K160553: DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S (2017), 0 descendants of its own

## Indications for use
The Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. 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 and Anteromedial 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, * Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and * Lateral Distal Fibula Plates are intended for fixation of osteotomnies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

Source page: https://510kreport.com/device/K121601
Methodology: https://510kreport.com/methodology