Cleared Traditional

K203832 - FuseForce Flex Dynamic Compression System

K203832 is an FDA 510(k) clearance for FuseForce Flex Dynamic Compression System, manufactured by Wright Medical. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K203832 · Wright Medical · Orthopedic device
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May 2021
Decision
128d
Days
Class 2
Risk

K203832 is an FDA 510(k) clearance for the FuseForce™ Flex Dynamic Compression System. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Wright Medical (Memphis, US). The FDA issued a Cleared decision on May 7, 2021 after a review of 128 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 Wright Medical devices

FDA 510(k) Submission Details - K203832

510(k) Number K203832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2020
Decision Date May 07, 2021
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, 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 - JDR Staple, Fixation, Bone

All 130
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K203832.
DynaClip® Bone Staple
K220812 · MedShape, Inc. · Aug 2022
EasyClip® and EasyClip® Xpress
K210582 · Stryker GmbH · Jun 2022
StealthFix Intraosseous Fixation System
K220181 · Nextremity Solutions, Inc. · Mar 2022
Medline UNITE REFLEX Nitinol Staple System
K210482 · Medline Industries, Inc. · Apr 2021
Ligament Staple
K210456 · Medacta International S.A. · Apr 2021
Arthrex DynaNite Nitinol Staples
K203180 · Arthrex, Inc. · Dec 2020