Cleared Traditional

K193533 - WIN Flexible Nail System (FDA 510(k) Clearance)

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

K193533 · Biomet, Inc. · Orthopedic device
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Feb 2020
Decision
62d
Days
Class 2
Risk

K193533 is an FDA 510(k) clearance for the WIN Flexible Nail System. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 20, 2020 after a review of 62 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 Biomet, Inc. devices

Submission Details

510(k) Number K193533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2019
Decision Date February 20, 2020
Days to Decision 62 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 122d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDS Nail, 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 - JDS Nail, Fixation, Bone

All 52
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K193533.
TRIGEN Stable Lock Nut & Washer
K243608 · Smith & Nephew, Inc. · Jun 2025
TRIGEN MAX Tibial Nail System
K240061 · Smith & Nephew, Inc. · Sep 2024
TRIGEN INTERTAN 10S Nail System
K241804 · Smith & Nephew, Inc. · Aug 2024
NET BRAND Osteosynthesis Nailing System
K233150 · Narang Medical , Ltd. · Feb 2024
TRIGEN META-NAIL Nail System
K230761 · Smith & Nephew, Inc. · Jun 2023