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FDA 510(k)

Medtronic Total Hip Arthroplasty System

K-Number: K183129 · 2019-07-26

ApplicantMedtronic Advanced Energy
Decision Date2019-07-26
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medtronic Total Hip Arthroplasty System is a medical device manufactured by Medtronic Advanced Energy. It received FDA 510(k) clearance on 2019-07-26 under approval number K183129. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medtronic Total Hip Arthroplasty System?

Medtronic Total Hip Arthroplasty System is a medical device that received FDA 510(k) clearance on 2019-07-26. It is manufactured by Medtronic Advanced Energy. The 510(k) number is K183129.

When was Medtronic Total Hip Arthroplasty System approved by the FDA?

Medtronic Total Hip Arthroplasty System received FDA 510(k) clearance on 2019-07-26, under approval number K183129.

What company makes Medtronic Total Hip Arthroplasty System?

Medtronic Total Hip Arthroplasty System is manufactured by Medtronic Advanced Energy.

What is the FDA product code for Medtronic Total Hip Arthroplasty System?

The FDA product code for Medtronic Total Hip Arthroplasty System is LPH.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT07613203 Forced-Air Warming for Preventing Perioperative Hypothermia During Total Knee Arthroplasty COMPLETED NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40025985 Patient-reported outcome measures offer little additional value two years after arthroplasty : a systematic review and meta-analysis. The bone & joint journal (2025)

Other Devices by Medtronic Advanced Energy

K152703PlasmaBlade TnA Tonsil and Adenoid Dissection Device K170381Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini K170610PlasmaBlade T K170296CoreCath 2.7S K181257PlasmaBlade X 3.0S, PlasmaBlade X 4.0

Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, 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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