Cleared Traditional

KLS Martin Level One Rib Fixation System

K222397 · KLS-Martin L.P. · Orthopedic
Mar 2023
Decision
233d
Days
Class 2
Risk

About This 510(k) Submission

K222397 is an FDA 510(k) clearance for the KLS Martin Level One Rib Fixation 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 March 29, 2023, 233 days after receiving the submission on August 8, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K222397 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2022
Decision Date March 29, 2023
Days to Decision 233 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 IPS Forearm System
K250865 · HRS · Nov 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