Cleared Special

ORTHOLOC? SPS Shoulder Plating System

K191711 · Tornier, Inc. · Orthopedic
Jul 2019
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K191711 is an FDA 510(k) clearance for the ORTHOLOC? SPS Shoulder Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on July 17, 2019, 21 days after receiving the submission on June 26, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K191711 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2019
Decision Date July 17, 2019
Days to Decision 21 days
Submission Type Special
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