MBF · Class II · 21 CFR 888.3670

FDA Product Code MBF: Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented

Under FDA product code MBF, semi-constrained shoulder prostheses with metal and polymer bearing surfaces are cleared for hemiarthroplasty and total shoulder replacement.

These implants replace the humeral head with a metal component that articulates against a glenoid surface — either native bone in hemiarthroplasty or a polymer component in total shoulder replacement. They differ from reverse shoulder prostheses in preserving the anatomical ball-and-socket orientation.

MBF devices are Class II medical devices, regulated under 21 CFR 888.3670 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Lima Corporate S.P.A., Zimmer, Inc. and Biomet, Inc..

37
Total
37
Cleared
139d
Avg days
1985
Since
Declining activity - 3 submissions in the last 2 years vs 8 in the prior period
Consistent review times: 125d avg (recent)

FDA 510(k) Cleared Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented Devices (Product Code MBF)

37 devices
1–24 of 37
Cleared Apr 13, 2026
Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
K253592
Zimmer, Inc.
Orthopedic · 147d
Cleared Aug 11, 2025
Identity Revision Humeral Stems
K251098
Zimmer, Inc.
Orthopedic · 123d
Cleared Jul 02, 2025
Identity Shoulder System
K250848
Zimmer, Inc.
Orthopedic · 104d
Cleared Jun 12, 2024
Identity Shoulder System
K240876
Zimmer, Inc.
Orthopedic · 75d
Cleared Jan 11, 2024
PRIMA Humeral System
K233712
Lima Corporate S.P.A.
Orthopedic · 52d
Cleared Dec 21, 2023
SMR Hybrid Glenoid System
K231099
Lima Corporate S.P.A.
Orthopedic · 247d
Cleared Nov 13, 2023
INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid
K230831
Depuy Ireland UC
Orthopedic · 231d
Cleared Jul 21, 2023
INHANCE™ Shoulder System, Sterile Single Use Instrumentation
K231516
Depuy Ireland UC
Orthopedic · 57d
Cleared Feb 03, 2023
SMR Shoulder System
K223876
Lima Corporate S.P.A.
Orthopedic · 42d
Cleared Oct 06, 2022
PRIMA TT Glenoid
K222427
Lima Corporate S.P.A.
Orthopedic · 56d
Cleared Sep 15, 2022
Identity Shoulder System
K213856
Zimmer, Inc.
Orthopedic · 279d
Cleared Jun 08, 2022
INHANCETM Hybrid Anatomic Glenoid Implant
K212933
Depuy Ireland UC
Orthopedic · 266d
Cleared May 19, 2022
SMR Reverse Liner
K220792
Lima Corporate S.P.A.
Orthopedic · 62d
Cleared May 20, 2021
Ignite Anatomic Shoulder System
K202716
Ignite Orthopedics, LLC
Orthopedic · 245d
Cleared Dec 17, 2020
SMR 140° Reverse Humeral Body
K201905
Lima Corporate S.P.A.
Orthopedic · 161d
Cleared Oct 28, 2020
Comprehensive Shoulder System
K193038
Biomet Manufacturing Corp
Orthopedic · 363d
Cleared Oct 10, 2019
SMR Finned Short Stems
K191963
Lima Corporate S.P.A.
Orthopedic · 79d
Cleared Jan 22, 2019
Compress and Mini Compress Anti-Rotation Spindles
K183553
Biomet, Inc.
Orthopedic · 33d
Cleared Oct 23, 2018
Humeral Short Stem System
K173824
Shoulder Innovations, Inc.
Orthopedic · 309d
Cleared Aug 06, 2013
SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM
K130126
Biomet, Inc.
Orthopedic · 201d
Cleared Feb 05, 2009
SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM
K083439
Synthes (Usa)
Orthopedic · 77d
Cleared May 18, 2007
COFIELD TOTAL SHOULDER SYSTEM
K070565
Smith & Nephew, Inc.
Orthopedic · 79d
Cleared Feb 01, 2007
GLOBAL AP POROUS COATED HUMERAL STEM
K063652
DePuy Orthopaedics, Inc.
Orthopedic · 55d
Cleared Feb 17, 2005
BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS
K043100
Biomet, Inc.
Orthopedic · 100d

About Product Code MBF - Regulatory Context

510(k) Submission Activity

37 total 510(k) submissions under product code MBF since 1985, with 37 receiving FDA clearance (average review time: 139 days).

Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 8 in the prior period.

FDA 510(k) Review Time - MBF Product Code

FDA review times for MBF submissions have been consistent, averaging 125 days recently vs 140 days historically.

MBF devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →