Zimmer, Inc. · Class II · Cleared Dec 11, 2024
| K-number | K241873 |
| Device name | OsseoFit Stemless Shoulder System |
| Applicant | Zimmer, Inc. |
| Product code | PKC |
| Device class | Class II |
| Decision date | Dec 11, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 888.3660 |
The OsseoFit Stemless Shoulder System is a shoulder replacement implant consisting of a stemless humeral anchor with six fins and compatible glenoid components. It is intended for anatomic total shoulder applications in patients with osteoarthritis who are anatomically and structurally suited for implantation. The humeral component uses porous technology to allow biological fixation without cement, while compatible glenoid components can be implanted with or without cement.
The device features an anatomical, left/right-specific asymmetric humeral anchor with six fins of varying location, length, and height, available in Onlay and Inlay variants. The humeral implants incorporate OsseoTi porous technology for biological fixation and include anterior suture holes for soft tissue attachment. It is manufactured through additive manufacturing and designed for cementless application with compatible Identity or Convertible glenoid components.
Not stated in this summary.
The OsseoFit Stemless Shoulder System is substantially equivalent to the Sidus Stem-Free Shoulder and Comprehensive Nano Stemless Shoulder predicates because it shares identical intended use (anatomic total shoulder for osteoarthritis), similar indications (cementless humeral fixation with optional cemented glenoid), and comparable technological characteristics including materials, design features (porous coating, anatomical design), packaging, and sterilization. Non-clinical testing demonstrated equivalent structural and biomechanical performance across fatigue, fixation, and functional analyses.
View the full FDA submission: accessdata.fda.gov