Cleared Traditional

K261892 - ProRib Fixation System

K261892 is an FDA 510(k) clearance for ProRib Fixation System, manufactured by Costa Surgical, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K261892 · Costa Surgical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
110d
Days
Class 2
Risk

K261892 is an FDA 510(k) clearance for the ProRib 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 Costa Surgical, Inc. (Chandler, US). The FDA issued a Cleared decision on September 23, 2026 after a review of 110 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 Costa Surgical, Inc. devices

FDA 510(k) Submission Details - K261892

510(k) Number K261892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2026
Decision Date September 23, 2026
Days to Decision 110 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
12d faster than avg
Panel avg: 122d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 1303
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K261892.
TDM Large Bone Plate and Screw System
K261611 · Tdm Co., Ltd. · Oct 2026
Alians Forearm
K262649 · Newclip Technics · Sep 2026
EnHAnce PEEK Bunion System
K262098 · Nvision Biomedical Technologies · Sep 2026
TMC Implant Fixation System
K262963 · Treace Medical Concepts, Inc. · Sep 2026
Tempo Plating System
K261647 · Pace Surgical · Sep 2026
FRAXION 3.5 Plate System (Various - See Catalog)
K261830 · Ortler Global Tibbi Gerecler Anonim Sirketi · Aug 2026