Cleared Traditional

Pectus Versa System (K251050) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251050 · Gm Dos Reis Industria E Comercio · Orthopedic device
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Dec 2025
Decision
260d
Days
Class 2
Risk

K251050 is an FDA 510(k) clearance for the Pectus Versa 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 Gm Dos Reis Industria E Comercio (Campinas, BR). The FDA issued a Cleared decision on December 19, 2025 after a review of 260 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 Gm Dos Reis Industria E Comercio devices

Submission Details

510(k) Number K251050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2025
Decision Date December 19, 2025
Days to Decision 260 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
138d slower than avg
Panel avg: 122d · This submission: 260d
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 697
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K251050.
TriMed Volar Bearing Plates (VBEAL-13-7S)
K254002 · TriMed, Inc. · Jan 2026
Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates
K252807 · Arthrex, Inc. · Jan 2026
TRILEAP Plating System
K253178 · Crossroads Extremity Systems · Jan 2026
BRUSIO Trauma Toolbox System
K252191 · Bonebridge AG · Dec 2025
KLS Martin Pure Pectus System
K250988 · KLS-Martin L.P. · Dec 2025
APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw)
K252897 · A Plus Biotechnology Co., Ltd. · Dec 2025