HyperFlex® Bunion Correction System— 510(k) K252997

Name: FDA 510(k) clearance K252997
Creator: U.S. Food and Drug Administration
Published: 2025-12-11

Substantially Equivalent

Hyperflex Medical

FDA 510(k) clearance K252997 for HyperFlex® Bunion Correction System, Substantially Equivalent on 2025-12-11. Applicant: Hyperflex Medical. Device class: 2.

Clearance details

Applicant: Hyperflex Medical
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-09-18
Decision date: 2025-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Huron, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

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K262098 — EnHAnce PEEK Bunion System2026-09-18
K262963 — TMC Implant Fixation System2026-09-15
K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03
K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
K262537 — Versalock Sterile Plating System2026-08-19

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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 →

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