Cleared Traditional

BPS Wrist Fracture System

K242343 · Orthonovis, Inc. · Orthopedic
Oct 2024
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K242343 is an FDA 510(k) clearance for the BPS Wrist Fracture System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Orthonovis, Inc. (Palm Coast, US). The FDA issued a Cleared decision on October 4, 2024, 58 days after receiving the submission on August 7, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K242343 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2024
Decision Date October 04, 2024
Days to Decision 58 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

Similar Devices — HRS Plate, Fixation, Bone

All 1291
Xpert Hand
K253906 · Newclip Technics · Mar 2026
DePuy Synthes VOLT? Proximal Tibia 3.5 Plating System
K260069 · Synthes GmbH · Mar 2026
Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
K260353 · Arthrex, Inc. · Mar 2026
VOLT? Ankle Trauma 2.7/3.5 Plating System; VOLT? Calcaneus 2.7 Plating System
K254054 · Synthes GmbH · Mar 2026
HKT Anatomical Locking Trauma System
K254249 · Hankil Tech Medical Co., Ltd. · Feb 2026
RIB LINK? Fixation System
K252166 · Globus Medical, Inc. · Feb 2026