FuseForce Flex Dynamic Compression System— 510(k) K203832

Name: FDA 510(k) clearance K203832
Creator: U.S. Food and Drug Administration
Published: 2021-05-07

Substantially Equivalent

Wright Medical

FDA 510(k) clearance K203832 for FuseForce Flex Dynamic Compression System, Substantially Equivalent on 2021-05-07. Applicant: Wright Medical. Device class: 2.

Clearance details

Applicant: Wright Medical
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2020-12-30
Decision date: 2021-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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K243742 — Arthrex DynaNite Nitinol Staples2025-01-31
K243658 — TMC Compression Implant System2024-12-26

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Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K203832

K-number listed on FDA's recall record

Z-0853-2022 — EasyFuse Dynamic Compression System Instrument PackClass II·Terminated·Wright Medical Technology, Inc.·20220310

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203832.

Data sourced from openFDA. This site is unofficial and independent of the FDA.