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510(k) K940328

Device
PRIME CEMENTED HIP SYSTEM
Applicant
ORTHOPAEDIC INNOVATIONS, INC.
510(k) number
K940328
Product code
JDI  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1995-04-07
Date received
1994-01-24
Regulation
888.3350
Classification name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
NICHOLAS A GUSTILO
Address
825 S. 8th St. Suite 700 Minneapolis MN US 55404 55404

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JDI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.2026-08-24
K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.2026-07-01
K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.2026-03-12
K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet2025-07-31
K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.2024-10-21
K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics2024-08-02
K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2024-04-12
K233261Global Modular Replacement SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2023-12-08
K222056Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeHowmedica Osteonics Corp., Dba Stryker Orthopaedics2023-01-26
K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics2022-02-01
K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.2022-01-05
K210842VerSys Cemented Revision/CalcarZimmer, Inc.2021-12-10
K203815ELEOS Limb Salvage System with BioGripOnkos Surgical2021-06-09
K203588ELEOS™ Limb Salvage SystemOnkos Surgical2021-02-05
K203090ELEOS Limb Salvage System featuring BIOGRIPOnkos Surgical2020-12-11

Legacy Summary#

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FDA Review#

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