Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MBF — Predicate Candidate Screening
37 FDA 510(k) clearances under this product code; the 50 most recent screened below.
100 daysmedian FDA review time
266 days90th percentile
37clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral | Zimmer, Inc. | 2026-04-13 | 147 | 0 |
| K251098 | Identity Revision Humeral Stems | Zimmer, Inc. | 2025-08-11 | 123 | 0 |
| K250848 | Identity Shoulder System | Zimmer, Inc. | 2025-07-02 | 104 | 0 |
| K240876 | Identity Shoulder System | Zimmer, Inc. | 2024-06-12 | 75 | 0 |
| K233712 | PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.P.A. | 2024-01-11 | 52 | 0 |
| K231099 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2023-12-21 | 247 | 0 |
| K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE | Depuy Ireland UC | 2023-11-13 | 231 | 0 |
| K231516 | INHANCE™ Shoulder System, Sterile Single Use Instrumentation | Depuy Ireland UC | 2023-07-21 | 57 | 0 |
| K223876 | SMR Shoulder System | Lima Corporate S.P.A. | 2023-02-03 | 42 | 0 |
| K222427 | PRIMA TT Glenoid | Lima Corporate S.P.A. | 2022-10-06 | 56 | 3 |
| K213856 | Identity Shoulder System | Zimmer, Inc. | 2022-09-15 | 279 | 0 |
| K212933 | INHANCETM Hybrid Anatomic Glenoid Implant | Depuy Ireland UC | 2022-06-08 | 266 | 0 |
| K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022-05-19 | 62 | 0 |
| K202716 | Ignite Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021-05-20 | 245 | 0 |
| K201905 | SMR 140° Reverse Humeral Body | Lima Corporate S.P.A. | 2020-12-17 | 161 | 0 |
| K193038 | Comprehensive Shoulder System | Biomet Manufacturing Corp | 2020-10-28 | 363 | 1 |
| K191963 | SMR Finned Short Stems | Lima Corporate S.P.A. | 2019-10-10 | 79 | 0 |
| K183553 | Compress and Mini Compress Anti-Rotation Spindles | Biomet, Inc. | 2019-01-22 | 33 | 0 |
| K173824 | Humeral Short Stem System | Shoulder Innovations, Inc. | 2018-10-23 | 309 | 0 |
| K163397 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2017-06-29 | 206 | 1 |
| K162068 | ARROW Anatomical Porous glenoid | Fournitures Hospitalieres Industrie | 2017-04-10 | 258 | 0 |
| K140390 | TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS | Biomet Manufacturing Corp | 2014-09-10 | 208 | 0 |
| K130126 | SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE S | Biomet, Inc. | 2013-08-06 | 201 | 0 |
| K123297 | COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM | Biomet Manufactuting Corp. | 2012-11-20 | 29 | 0 |
| K112905 | COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM | Biomet Orthopedics, LLC | 2012-05-24 | 234 | 0 |
| K083439 | SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM | Synthes (Usa) | 2009-02-05 | 77 | 0 |
| K081448 | ENCORE SHOULDER REVISION GLENOID | Encore Medical L.P. | 2008-09-30 | 130 | 1 |
| K070565 | COFIELD TOTAL SHOULDER SYSTEM | Smith & Nephew, Inc. | 2007-05-18 | 79 | 0 |
| K063652 | GLOBAL AP POROUS COATED HUMERAL STEM | DePuy Orthopaedics, Inc. | 2007-02-01 | 55 | 0 |
| K060716 | VERSA-DIAL HUMERAL HEAD PROSTHESIS | Biomet Manufacturing Corp | 2006-06-12 | 87 | 0 |
| K060692 | COMPREHENSIVE PRIMARY SHOULDER STEMS | Biomet Manufacturing Corp | 2006-05-30 | 76 | 2 |
| K043100 | BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED | Biomet, Inc. | 2005-02-17 | 100 | 0 |
| K032895 | BI-ANGULAR SHOULDER SYSTEM | Biomet, Inc. | 2003-11-20 | 64 | 0 |
| K010635 | INTERLOK / HA COPELAND RESURFACING HEADS | Biomet, Inc. | 2001-08-20 | 171 | 0 |
| K011099 | GLOBAL FX POROUS-COATED HUMERAL STEM | DePuy Orthopaedics, Inc. | 2001-07-06 | 86 | 0 |
| K011047 | GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT | DePuy Orthopaedics, Inc. | 2001-06-28 | 83 | 0 |
| K844415 | POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS | Depuy, Inc. | 1985-01-23 | 70 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda