Cleared Traditional

K241282 - RibFix Titan Fixation System

K241282 is the FDA 510(k) clearance for RibFix Titan Fixation System by Riverpoint Medical. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K241282 · Riverpoint Medical · Orthopedic device
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Aug 2024
Decision
104d
Days
Class 2
Risk

K241282 is an FDA 510(k) clearance for the RibFix Titan™ Fixation 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 Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on August 19, 2024 after a review of 104 days - within the typical 510(k) review window.

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 Riverpoint Medical devices

Submission Details

510(k) Number K241282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2024
Decision Date August 19, 2024
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
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 885
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K241282.
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K240318 · Bonebridge AG · Aug 2024
NCB® Polyaxial Locking Plate System
K241754 · Zimmer Switzerland Manufacturing GmbH · Aug 2024
CoLink NeoFuse MIS Plating System (see attached parts list)
K241387 · In2bones USA · Aug 2024
Freefix Forearm Plating System
K242055 · Skeletal Dynamics, Inc. · Aug 2024