Cleared Traditional

K222624 - KLS Martin LINOS Wrist System

K222624 is the FDA 510(k) clearance for KLS Martin LINOS Wrist System by KLS-Martin L.P.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K222624 · KLS-Martin L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
267d
Days
Class 2
Risk

K222624 is an FDA 510(k) clearance for the KLS Martin LINOS Wrist System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on May 25, 2023 after a review of 267 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all KLS-Martin L.P. devices

Submission Details

510(k) Number K222624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2022
Decision Date May 25, 2023
Days to Decision 267 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 122d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K222624.
ARIX Ankle System
K231441 · Jeil Medical Corporation · Jul 2023
APTUS® 3.5 TriLock Straight Plates
K230971 · Medartis AG · Jun 2023
Smith & Nephew ACCORD™ Cable System
K223762 · Smith & Nephew · May 2023
ARIX Humerus System
K230938 · Jeil Medical Corporation · May 2023
PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System
K222381 · Stryker GmbH · Apr 2023
ALPHALOK Plating System
K230204 · Vilex, LLC · Apr 2023