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FDA 510(k)

TaperSet™ Hip System

K-Number: K252846 · 2025-11-20

ApplicantShalby Advanced Technologies, Inc. Dba Consensus Orthopedics
Decision Date2025-11-20
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TaperSet™ Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K252846. 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 TaperSet™ Hip System?

TaperSet™ Hip System is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. The 510(k) number is K252846.

When did TaperSet™ Hip System receive FDA 510(k) clearance?

TaperSet™ Hip System received FDA 510(k) clearance on 2025-11-20, under 510(k) number K252846.

Who is the listed applicant for TaperSet™ Hip System?

The FDA 510(k) record lists Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TaperSet™ Hip System?

The FDA product code for TaperSet™ Hip System is LPH.

Other records listing Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics 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.

K260796Tahoe Unicondylar Knee System with TiNbN Overcoat

Related Devices (Code: LPH)

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.

K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCK251270Taperloc® Complete Hip StemBiomet, Inc.K252623G7® Revision Acetabular SystemZimmer, Inc.K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.

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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