Cleared Special

K262955 - OsseoFit Stemless Shoulder System

K262955 is an FDA 510(k) clearance for OsseoFit Stemless Shoulder System, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code PKC cleared through the Special 510(k) pathway after a 31-day FDA review.

K262955 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
31d
Days
Class 2
Risk

K262955 is an FDA 510(k) clearance for the OsseoFit Stemless Shoulder System. Classified as Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained (product code PKC), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 24, 2026 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zimmer, Inc. devices

FDA 510(k) Submission Details - K262955

510(k) Number K262955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2026
Decision Date September 24, 2026
Days to Decision 31 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 122d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

PKC Device Classification - Class 2, Special Controls

Product Code PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition Replacement Of The Humeral Head For Total Anatomic Shoulder Arthroplasty
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Zimmer Biomet
Alexandria Irwin

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained

All 19
Devices cleared under the same product code (PKC) and FDA review panel - the closest regulatory comparables to K262955.
FX V135 EASYTECH® Shoulder System
K254154 · FX Shoulder Solutions, Inc. · May 2026
AETOS Shoulder System Stemless Humeral Prosthesis
K252129 · Smith & Nephew, Inc. · Oct 2025
INHANCE INTACT™
K243248 · Depuy Ireland UC · Dec 2024
OsseoFit Stemless Shoulder System
K241873 · Zimmer, Inc. · Dec 2024
AETOS Shoulder System Stemless Humeral Prosthesis
K240716 · Smith & Nephew, Inc. · Nov 2024
SMR Stemless Anatomic
K221758 · Lima Corporate S.P.A. · Mar 2023