Zimmer, Inc. · Class II · Cleared Apr 27, 2026
| K-number | K260182 |
| Device name | Avenir® Müller Stem; Avenir Complete Hip System |
| Applicant | Zimmer, Inc. |
| Product code | LZO |
| Device class | Class II |
| Decision date | Apr 27, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3353 |
The Avenir® Müller Stem and Avenir Complete™ Hip System are uncemented hip prostheses intended for cementless total or hemi hip arthroplasty to treat degenerative joint disease, traumatic fractures, avascular necrosis, and failed previous hip surgery. The stems are manufactured from titanium alloy (Ti-6Al-4V), feature a wedge-shaped design with proximal-to-distal taper, and include proximal ribs for stability.
Materials are identical to predicate devices (titanium alloy Ti-6Al-4V). Design features are identical, including wedge-shaped geometry and proximal ribs. Sterilization method is identical. Air plasma spray coating with dual CP-titanium/hydroxyapatite coating is similar to the primary predicate device. The submission involves adding a second production line at Medicoat S.A.S for cleaning, porous coating, HA coating, and packaging.
Distal fatigue testing per ISO 7206-4 and coating characterization of the dual CP-Ti/HA coating.
The subject devices have identical intended use, indications for use, materials, and design features as the predicate devices. Technological differences (air plasma spray coating) are minor and addressed through performance testing. No clinical testing was required. The performance testing and characterization demonstrate substantial equivalence to the predicate devices without raising new safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov