Magna-Rom 21 Knee Systeem

by Sulzer Orthopedics, Inc.

510(k) K991143

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

510(k) K991143↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK991143	Date11 Jun 1999Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K991143
FDA Product Code: JWH

Device Class: Class II
Regulation: 21 CFR Part 888.3560
Advisory Committee: Orthopedic
FDA Decision: SESE Substantially Equivalent

Other devices from Sulzer Orthopedics, Inc.

Natural-Hip Cocr Offset Stem

Class II
Sulzer Orthopedics Converge Acetabular System

Class II
Natural-Knee II Posterior Stabilized (P.S.) Condylar Knee Tibial Inserts

Class II
Natural-Hip Porous Stem with Offset

Class II
Allofit Acetabular System 32mm Alpha Durasul Inserts

Class II
Unicondylar Interpositional Spacer

Class II

See all devices from Sulzer Orthopedics, Inc. →