Montross Extremity Medical Hemi Implant System— 510(k) K221220

Name: FDA 510(k) clearance K221220
Creator: U.S. Food and Drug Administration
Published: 2023-04-19

Substantially Equivalent

Montross Extremity Medical

FDA 510(k) clearance K221220 for Montross Extremity Medical Hemi Implant System, Substantially Equivalent on 2023-04-19. Applicant: Montross Extremity Medical. Device class: 2.

Clearance details

Applicant: Montross Extremity Medical
Product code: Code KWD
Device class: Class 2
Regulation: 21 CFR 888.3730
Advisory panel: Orthopedic
Date received: 2022-04-27
Decision date: 2023-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWD

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K250074 — HYALEX® MTP Hemiarthroplasty Implant2026-04-03
K240268 — Accu-Joint Hemi Implant2024-02-29
K222964 — BioPoly Lesser Toe Hemiarthroplasty Implant2022-11-22
K201393 — restor3d MTP Implant2022-05-25
K203634 — BioPoly Great Toe Hemiarthroplasty Implant2021-02-02

Adverse events under product code KWD

product code KWD

Injury: 164
Total: 164

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.