Cleared Traditional

FuseForce™ Flex Dynamic Compression System (K203832) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 65
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