FDA 510(k)

RT-PLUS MODULAR CEMENTED KNEE COMPONENTS

K-Number: K003504 · 2001-05-11

Decision Date2001-05-11

Product CodeKRO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

RT-PLUS MODULAR CEMENTED KNEE COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Plus Orthopedics. It received FDA 510(k) clearance on 2001-05-11 under 510(k) number K003504. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RT-PLUS MODULAR CEMENTED KNEE COMPONENTS?

RT-PLUS MODULAR CEMENTED KNEE COMPONENTS is a medical device that received FDA 510(k) clearance on 2001-05-11. The listed applicant is Plus Orthopedics. The 510(k) number is K003504.

When did RT-PLUS MODULAR CEMENTED KNEE COMPONENTS receive FDA 510(k) clearance?

RT-PLUS MODULAR CEMENTED KNEE COMPONENTS received FDA 510(k) clearance on 2001-05-11, under 510(k) number K003504.

Who is the listed applicant for RT-PLUS MODULAR CEMENTED KNEE COMPONENTS?

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

What is the FDA product code for RT-PLUS MODULAR CEMENTED KNEE COMPONENTS?

The FDA product code for RT-PLUS MODULAR CEMENTED KNEE COMPONENTS is KRO.

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Other records listing Plus Orthopedics as applicant

K032126PROMOS SHOULDER K033763MODIFICATION TO SLIM GLIDING NAIL SYSTEM K032709MODULAR PLUS HIP STEM K032548IP-XS COMPRESSION NAIL SYSTEM K032215VKS/TC-PLUS REVISION KNEE K032052UC-PLUS SOLUTION UNICONDYLAR KNEE

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Related Devices (Code: KRO)

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge BumperHowmedica Osteonics Corp., Dba Stryker Orthopaedics K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics K242871ATTUNE™ Revision Hinge KneeDepuy Ireland UC K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial InseMicroport Orthopedics, Inc.

Official Source

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