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510(k) K162125

MALUC™ Total Hip Arthroplasty System by Surgtech, Inc. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2017
Date Received
August 1, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

Other clearances by Surgtech, Inc.

  • K191192 — SurgTech GENOLL Total Knee System (August 1, 2019)
  • K173455 — SurgTech Bipolar Head System (June 14, 2018)
  • K163363 — SurgTech Thoracolumbosacral (TLS) Posterior Fixation System (April 5, 2017)
  • K161894 — SurgTech Trauma System (February 21, 2017)
  • K152200 — SurgTech Interbody System (March 25, 2016)

Other clearances for product code JDI

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  • K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectr (October 21, 2024)
  • K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (August 2, 2024)
  • K240418 — Stryker Orthopaedics Hip Systems Labeling Update (April 12, 2024)
  • K233261 — Global Modular Replacement System (December 8, 2023)
  • K222056 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (January 26, 2023)
  • K220216 — C-Stem AMT LE Prosthesis (July 22, 2022)
  • K213701 — Exeter® X3® RimFit® Cup (February 1, 2022)
  • K213816 — MPO Hip Instruments (January 5, 2022)
  • K210842 — VerSys Cemented Revision/Calcar (December 10, 2021)