Cleared Traditional

K241709 - Pectus Blu Support Bar System

K241709 is the FDA 510(k) clearance for Pectus Blu Support Bar System by Biomet Microfixation. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K241709 · Biomet Microfixation · Orthopedic device
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Sep 2024
Decision
98d
Days
Class 2
Risk

K241709 is an FDA 510(k) clearance for the Pectus Blu Support Bar 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 Biomet Microfixation (Jacksonville, US). The FDA issued a Cleared decision on September 19, 2024 after a review of 98 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 Biomet Microfixation devices

Submission Details

510(k) Number K241709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2024
Decision Date September 19, 2024
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
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 899
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K241709.
Pangea Platform
K242445 · Stryker GmbH · Oct 2024
BPS Wrist Fracture System
K242343 · Orthonovis, Inc. · Oct 2024
Protean Fragment Plating System
K241815 · Skeletal Dynamics, Inc. · Sep 2024
TriMed Bridge Plates
K241942 · TriMed, Inc. · Sep 2024
Fine Osteotomy™
K241356 · Bodycad Laboratories, Inc. · Sep 2024
EVOS Patella Plates
K240487 · Smith & Nephew · Sep 2024