Cleared Traditional

KLS Martin IPS Forearm System

K250865 · KLS-Martin L.P. · Orthopedic
Nov 2025
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K250865 is an FDA 510(k) clearance for the KLS Martin IPS Forearm System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on November 14, 2025, 238 days after receiving the submission on March 21, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K250865 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2025
Decision Date November 14, 2025
Days to Decision 238 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

More from KLS-Martin L.P.

View all
KLS Martin Pure Pectus System
K253660 · HRS · Feb 2026
KLS Martin Ixos System
K254162 · Feb 2026
KLS Martin Pure Pectus System
K250988 · HRS · Dec 2025
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
K252573 · GXN · Nov 2025
KLS Martin Ixos System
K250620 · HRS · Aug 2025