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FDA 510(k)

Precision Casting Solutions Total Hip System

K-Number: K192450 · 2019-12-17

ApplicantPrecision Casting Solution, LLC
Decision Date2019-12-17
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Precision Casting Solutions Total Hip System is a medical device manufactured by Precision Casting Solution, LLC. It received FDA 510(k) clearance on 2019-12-17 under approval number K192450. 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 Precision Casting Solutions Total Hip System?

Precision Casting Solutions Total Hip System is a medical device that received FDA 510(k) clearance on 2019-12-17. It is manufactured by Precision Casting Solution, LLC. The 510(k) number is K192450.

When was Precision Casting Solutions Total Hip System approved by the FDA?

Precision Casting Solutions Total Hip System received FDA 510(k) clearance on 2019-12-17, under approval number K192450.

What company makes Precision Casting Solutions Total Hip System?

Precision Casting Solutions Total Hip System is manufactured by Precision Casting Solution, LLC.

What is the FDA product code for Precision Casting Solutions Total Hip System?

The FDA product code for Precision Casting Solutions Total Hip System is LPH.

Related Clinical Trials

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 NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT07614373 Virtual Reality-based Mindfulness Training for Mental Health After Stroke NOT_YET_RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41209898 Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty. Cureus (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 29258356 Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system. Accountability in research (2018)

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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