Cleared Traditional

K193533 - WIN Flexible Nail System

K193533 is the FDA 510(k) clearance for WIN Flexible Nail System by Biomet, Inc.. It is a Class 2 Orthopedic device (product code JDS) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K193533 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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 37
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K193533.
TRIGEN META-NAIL Nail System
K230761 · Smith & Nephew, Inc. · Jun 2023
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K201336 · Synthes USA Products, LLC · Sep 2020
Auxein Nailing System
K192003 · Auxein Medical Private Limited · Jun 2020
CHINA NAILS AND ACCESSORIES
K123948 · Smith & Nephew, Inc. · Mar 2013
SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
K111667 · Synthes (Usa) · Dec 2011
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS
K072095 · Synthes (Usa) · Sep 2007