Cleared Traditional

KLS Martin Pure Pectus System

K253660 · KLS-Martin L.P. · Orthopedic
Feb 2026
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K253660 is an FDA 510(k) clearance for the KLS Martin Pure Pectus 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 February 20, 2026, 92 days after receiving the submission on November 20, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K253660 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2025
Decision Date February 20, 2026
Days to Decision 92 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

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