Dive Brief:
- Zimmer Biomet received Food and Drug Administration clearance for a new stemless shoulder implant, called Osseofit.
- The implant is shaped to match the anatomy of patients’ humerus, or upper shoulder bone, while preserving as much of their healthy bone as possible in total shoulder replacement procedures. Zimmer announced the clearance on Friday.
- CEO Ivan Tornos highlighted stemless shoulder implants as a meaningful growth driver for the orthopedics company in an Oct. 30 investor call.
Dive Insight:
Stemless shoulder implants are designed to be attached to the humerus without using a stem to stabilize the implant, which requires drilling down into the bone. As younger and more active patients require shoulder replacements, bone preservation is “increasingly critical” to accommodate potential revision procedures in the future, John Sperling, a professor of orthopedic surgery at Mayo Clinic who helped develop the Osseofit system, said in a statement. Mayo Clinic has a financial interest in the technology.
Osseofit is designed to match the natural asymmetry of the humerus, Sperling added. The device features left- or right-sided anchor implants and uses porous metal intended to mimic spongy bone tissue.
The Osseofit system is available in a singular instrument tray, which Zimmer said should maximize workflow and sterile processes, and could allow it to fit nicely in ambulatory surgery centers (ASCs).
The company and its peers have increasingly focused on ASCs as more joint replacement procedures move to the outpatient setting. Last year, Medicare added total shoulder replacements to its ASC covered procedures list.
The stemless implant would add to Zimmer’s portfolio of shoulder products. In February, the company received FDA clearance for a new surgical robot feature for total shoulder replacement procedures. As of October, Tornos said the company had done hundreds of cases on the robot in a limited market release.
Zimmer plans to begin selling the Osseofit stemless shoulder implant in the first quarter of 2025.
