Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HemiCAP MTP Resurfacing Hemi-Arthroplasty System

K-Number: K152454 · 2016-04-11

ApplicantArthrosurface, Inc.
Decision Date2016-04-11
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HemiCAP MTP Resurfacing Hemi-Arthroplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrosurface, Inc.. It received FDA 510(k) clearance on 2016-04-11 under 510(k) number K152454. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemiCAP MTP Resurfacing Hemi-Arthroplasty System?

HemiCAP MTP Resurfacing Hemi-Arthroplasty System is a medical device that received FDA 510(k) clearance on 2016-04-11. The listed applicant is Arthrosurface, Inc.. The 510(k) number is K152454.

When did HemiCAP MTP Resurfacing Hemi-Arthroplasty System receive FDA 510(k) clearance?

HemiCAP MTP Resurfacing Hemi-Arthroplasty System received FDA 510(k) clearance on 2016-04-11, under 510(k) number K152454.

Who is the listed applicant for HemiCAP MTP Resurfacing Hemi-Arthroplasty System?

The FDA 510(k) record lists Arthrosurface, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HemiCAP MTP Resurfacing Hemi-Arthroplasty System?

The FDA product code for HemiCAP MTP Resurfacing Hemi-Arthroplasty System is KWD.

Other records listing Arthrosurface, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203375OVOMotion Reverse Shoulder Arthroplasty SystemK200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemK190261BOSS Toe Fixation SystemK181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemK173964OVOMotion Shoulder Arthroplasty SystemK172383Arthrosurface Bone Screws

View all 11 devices →

Related Devices (Code: KWD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity MedicalK222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLCK201393restor3d MTP ImplantRestor3D, Inc.K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑