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Prolixus Total Knee System

by Otis Biotech Co., Ltd. 510(k)

Active United States

510(k) K170534

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK170534 Date9 Nov 2017ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 19 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 Prolixus Total Knee System is a cruciate-retaining, fixed-bearing total knee prosthesis (Product Code: JWH) designed for cemented implantation in total knee arthroplasty. It comprises a cobalt-chromium-molybdenum (CoCrMo) femoral component, a titanium alloy (Ti-6Al-4V) tibial baseplate, ultra-high molecular weight polyethylene (UHMWPE) tibial inserts, and a patellar component.

The system is supplied as a modular, cemented knee replacement intended for orthopedic use. Components are non-sterile and require sterilization prior to use, with no specific MRI safety labeling indicated. Sizes and configurations are standardized for adult total knee arthroplasty, and the device holds FDA 510(k) clearance (K170534) under the Orthopedic Advisory Committee’s review.

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