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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device shoulder arthroplasty implantation system
Definition Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
Product CodeQHE
Regulation Number 888.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 2
LIMACORPORATE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 2
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 5
ORTHOSOFT INC. (D/B/A ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 2
ORTHOSOFT INC. (D/B/A) ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSOFT, INC. (D/B/A ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 1
TECHMAH MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Off-Label Use 5 5
Patient Data Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Tornier S.A.S. II Aug-13-2021
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