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FDA 510(k)

ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System

K-Number: K233980 · 2024-03-21

ApplicantDepuy Ireland UC
Decision Date2024-03-21
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2024-03-21 under 510(k) number K233980. 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 ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System?

ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System is a medical device that received FDA 510(k) clearance on 2024-03-21. The listed applicant is Depuy Ireland UC. The 510(k) number is K233980.

When did ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System receive FDA 510(k) clearance?

ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System received FDA 510(k) clearance on 2024-03-21, under 510(k) number K233980.

Who is the listed applicant for ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System?

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

What is the FDA product code for ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System?

The FDA product code for ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System is KRO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT0283985014022 ATTUNE Cementless RP Clinical Performance EvaluationACTIVE_NOT_RECRUITINGNCT03204513Impact of Powered Knee-Ankle Prosthesis Leg on Everyday Community Mobility and Social InteractionACTIVE_NOT_RECRUITINGNCT05721560SINEFIX-2022 Pilot PhaseACTIVE_NOT_RECRUITINGNCT06326203Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb IschemiaNOT_YET_RECRUITINGNCT06812611Effects of High Intensity Laser Therapy in Muscle InjuriesRECRUITINGNCT06818448SINEFIX-2022 Comparative PhaseRECRUITING

Other records listing Depuy Ireland UC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemK260480VELYS™ Robotic-Assisted SolutionK260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementK253624INHANCE™ Reverse Shoulder SystemK253551VELYS™ Hip NavigationK253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors

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Related Devices (Code: KRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker OrthopaedicsK252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge BumperHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK252303Stem Extension Line (USTAR II System)United Orthopedic CorporationK251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK242871ATTUNE™ Revision Hinge KneeDepuy Ireland UCK240043EVOLUTION® 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

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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