HemiCAP MTP Resurfacing Hemi-Arthroplasty System— 510(k) K152454

Name: FDA 510(k) clearance K152454
Creator: U.S. Food and Drug Administration
Published: 2016-04-11

Substantially Equivalent

Arthrosurface, Inc.

FDA 510(k) clearance K152454 for HemiCAP MTP Resurfacing Hemi-Arthroplasty System, Substantially Equivalent on 2016-04-11. Applicant: Arthrosurface, Inc.. Device class: 2.

Clearance details

Applicant: Arthrosurface, Inc.
Product code: Code KWD
Device class: Class 2
Regulation: 21 CFR 888.3730
Advisory panel: Orthopedic
Date received: 2015-08-28
Decision date: 2016-04-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Franklin, MA, 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
K221220 — Montross Extremity Medical Hemi Implant System2023-04-19
K222964 — BioPoly Lesser Toe Hemiarthroplasty Implant2022-11-22
K201393 — restor3d MTP Implant2022-05-25

More clearances from Arthrosurface, Inc.

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K203375 — OVOMotion Reverse Shoulder Arthroplasty System2021-06-24
K200718 — Arthrosurface WristMotion Total Wrist Arthroplasty System2020-10-15
K190261 — BOSS Toe Fixation System2019-08-14
K181280 — Patello-Femoral Wave (Kahuna) Arthroplasty System2018-06-14
K173964 — OVOMotion Shoulder Arthroplasty System2018-04-18

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.