Cleared Traditional

K240876 - Identity Shoulder System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240876 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
75d
Days
Class 2
Risk

K240876 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 June 12, 2024 after a review of 75 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zimmer, Inc. devices

Submission Details

510(k) Number K240876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2024
Decision Date June 12, 2024
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K240876.
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
K250848 · Zimmer, Inc. · Jul 2025
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