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510(k) K212815

Device
My3D® Personalized Pelvic Reconstruction
Applicant
Onkos Surgical
510(k) number
K212815
Product code
LPH  
Decision
Substantially Equivalent (SESE)
Decision date
2022-07-06
Date received
2021-09-03
Regulation
888.3358
Classification name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Matthew Vernak
Address
77 E. Halsey Rd. Parsippany NJ US 07054 07054

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LPH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC2026-06-05
K251270Taperloc® Complete Hip StemBiomet, Inc.2026-05-19
K252623G7® Revision Acetabular SystemZimmer, Inc.2026-02-04
K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.2026-01-28
K252067Velora Acetabular SystemRestor3D, Inc.2025-12-05
K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics2025-11-20
K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.2025-11-12
K251718ArTT Augments and Buttresses and Bone ScrewsLima Corporate S.P.A.2025-08-29
K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)2025-07-25
K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.2025-06-06
K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited2025-06-05
K242232Mpact 3D Metal Augments IIMedacta International S.A.2025-04-23
K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.2025-04-10
K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025-02-06
K243977EMPHASYS Acetabular SystemDepuy Ireland UC2025-01-22

Legacy Summary#

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FDA Review#

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