Cleared Traditional

AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws (K191641) - FDA 510(k) Clearance

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

K191641 · Industrias Medicas Sampedro S.A.S · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
89d
Days
Class 2
Risk

K191641 is an FDA 510(k) clearance for the AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Dis.... Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Industrias Medicas Sampedro S.A.S (La Estrella, CO). The FDA issued a Cleared decision on September 16, 2019 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Industrias Medicas Sampedro S.A.S devices

Submission Details

510(k) Number K191641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2019
Decision Date September 16, 2019
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 700
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K191641.
Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module
K191326 · Arthrex, Inc. · Oct 2019
Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module
K191344 · Arthrex, Inc. · Oct 2019
APTUS Wrist Spanning Plates 2.5
K191848 · Medartis AG · Sep 2019
NCB Plating System Distal Femur and Proximal Tibia
K192217 · Zimmer GmbH · Sep 2019
VariAx 2 System, VariAx 2 Mini Fragment System
K191412 · Stryker GmbH · Aug 2019
NCB Polyaxial Locking Plate System
K192021 · Zimmer GmbH · Aug 2019