Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device shoulder arthroplasty implantation system
Regulation Description Shoulder joint metal/polymer semi-constrained cemented prosthesis.
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
3D-SIDE
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 3
LIMA CORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
LINKBIO CORP.
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 7
ORTHOSOFT INC (D/B/A ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSOFT INC. (D/B/A) ZIMMER CAS
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSOFT INC. (D/B/A) ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 1
PRECISION AI PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 3
TECHMAH MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 5 5
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Off-Label Use 5 5
Patient Data Problem 5 5
Application Program Version or Upgrade Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 5 5
No Clinical Signs, Symptoms or Conditions 1 1

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