OsseoFit Stemless Shoulder System— 510(k) K262955
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K262955 for OsseoFit Stemless Shoulder System, Substantially Equivalent on 2026-09-24. Applicant: Zimmer, Inc.. Device class: 2.
Summary
The OsseoFit Stemless Shoulder System from Zimmer, Inc. is a total anatomic shoulder under PKC. The full code name spells out the category: uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained. In other words, the humeral component anchors in the metaphysis without a long stem down the shaft.
Class II, 21 CFR 888.3660, Orthopedic panel. Zimmer filed it as a Special 510(k).
Zimmer filed from Warsaw, Indiana. Review took 31 days (August 24 to September 24, 2026).
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Product code PKC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Warsaw, IN, US
Recent devices under product code PKC
view allMore clearances from Zimmer, Inc.
view all- K260831 — Z1 Hip System
- K261683 — Augment Off-Axis Instrument System
- K251840 — Zimmer® Persona® Personalized Knee System
- K260182 — Avenir® Müller Stem; Avenir Complete Hip System
- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
Adverse events under product code PKC
product code PKC- Injury
- 258
- Total
- 258
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.