Cleared Traditional

K250848 - Identity Shoulder System

K250848 is an FDA 510(k) clearance for Identity Shoulder System, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code MBF cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K250848 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
104d
Days
Class 2
Risk

K250848 is an FDA 510(k) clearance for the Identity Shoulder System. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (product code MBF), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 2, 2025 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3670 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Zimmer, Inc. devices

FDA 510(k) Submission Details - K250848

510(k) Number K250848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2025
Decision Date July 02, 2025
Days to Decision 104 days
Submission Type Traditional
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
18d faster than avg
Panel avg: 122d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBF Device Classification - Class 2, Special Controls

Product Code MBF Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3670
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 Peers - MBF Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented

All 36
Devices cleared under the same product code (MBF) and FDA review panel - the closest regulatory comparables to K250848.
Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
K253592 · Zimmer, Inc. · Apr 2026
Identity Revision Humeral Stems
K251098 · Zimmer, Inc. · Aug 2025
Identity Shoulder System
K240876 · Zimmer, Inc. · Jun 2024
PRIMA Humeral System
K233712 · Lima Corporate S.P.A. · Jan 2024
SMR Hybrid Glenoid System
K231099 · Lima Corporate S.P.A. · Dec 2023
INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid
K230831 · Depuy Ireland UC · Nov 2023