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Accin Total Knee System

by Accelerated Innovation, LLC

510(k) K081127

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK081127 Date17 Oct 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1195-2016 FDA Class II initiated 17 Dec 2015

    Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JWH
Device Class
Class II
Regulation
21 CFR Part 888.3560
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Accin Total Knee System is an orthopedic device intended for total knee arthroplasty. It is a substantially equivalent device cleared through the traditional 510(k) pathway.

The system is supplied by Accelerated Innovation, LLC and is authorized under FDA 510(k) clearance K081127. It is manufactured in Clifton, New Jersey, and is intended for use in orthopedic surgical procedures.

Other devices from Accelerated Innovation, LLC