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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 a medical device manufactured by Arthrosurface, Inc.. It received FDA 510(k) clearance on 2016-04-11 under approval 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. It is manufactured by Arthrosurface, Inc.. The 510(k) number is K152454.

When was HemiCAP MTP Resurfacing Hemi-Arthroplasty System approved by the FDA?

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

What company makes HemiCAP MTP Resurfacing Hemi-Arthroplasty System?

HemiCAP MTP Resurfacing Hemi-Arthroplasty System is manufactured by Arthrosurface, Inc..

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.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT05543941 Evaluating XPERIENCE™ Advanced Surgical Irrigation RECRUITING NCT04325022 Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA ACTIVE_NOT_RECRUITING NCT03073941 A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT07569549 Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Arthrosurface, Inc.

K161539Arthrosurface Bone Screws K172383Arthrosurface Bone Screws K170440KISSloc Suture System K170350ToeMATE® Hammertoe Correction System K162391AlignMATE™ Lapidus Arthrodesis System K181280Patello-Femoral Wave (Kahuna) Arthroplasty System

View all 11 devices →

Related Devices (Code: KWD)

K161279Life Spine Metatarsal Hemi ImplantLife Spine, Inc. K190261BOSS Toe Fixation SystemArthrosurface, Inc. K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc. K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc. K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC K222964BioPoly Lesser 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.

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