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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K262955

510(k) cleared

OsseoFit Stemless Shoulder System

Zimmer, Inc. · Sep 24, 2026 · K262955

FDA cleared the OsseoFit Stemless Shoulder System from Zimmer, Inc. on Sep 24, 2026 under K262955, a special 510(k). The device falls under product code PKC, Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained, regulated at 21 CFR 888.3660 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 24, 2026. The decision came 31 days later, inside the 90 FDA-day goal for a 510(k).

Zimmer, Inc. has 8 other decisions in the tracker over the last 12 months: K260831 (Z1 Hip System), K261683 (Augment Off-Axis Instrument System), K251840 (Zimmer® Persona® Personalized Knee System), K260182 (Avenir® Müller Stem; Avenir Complete Hip System).

Questions & Answers

What did FDA clear under K262955?

K262955 is the FDA 510(k) for OsseoFit Stemless Shoulder System, submitted by Zimmer, Inc.. FDA's decision date was Sep 24, 2026, under product code PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained).

Who makes the OsseoFit Stemless Shoulder System?

Zimmer, Inc., based in Warsaw, IN, is the applicant of record for K262955.

How long did the K262955 review take?

FDA received the submission on Aug 24, 2026 and issued its decision on Sep 24, 2026, 31 days later.

← All decisions in September 2026