Panels › Orthopedic › Product code MBF · Class 2
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Regulation 888.3670
1510(k)s in 12 months (37 all time)
0recalls in 12 months (20 all time)
12recalls that name a 510(k)
Top companies in MBF
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet, Inc. | 5 | 10 |
| Lima Corporate S.P.A. | 8 | 0 |
| Zimmer, Inc. | 5 | 0 |
| Biomet Manufacturing Corp | 4 | 0 |
| Limacorporate S.p.A | 0 | 4 |
| Zimmer Biomet, Inc. | 0 | 4 |
| Depuy Ireland UC | 3 | 0 |
| DePuy Orthopaedics, Inc. | 3 | 0 |
| Encore Medical L.P. | 1 | 1 |
| Biomet Manufactuting Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2025 | ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627 Open, Classified |
MBF | K193038 |
| Jan 12, 2024 | Limacorporate S.p.A PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code:
BASEPLATE D.25MM REGULAR/1975.14.500,
BASEPLATE D.28MM REGULAR/1975.14.800,
BASEPLATE D.25MM FULL WEDGED 10-degrees/ Open, Classified |
MBF | K222427 |
| Jun 27, 2023 | Limacorporate S.p.A REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R Open, Classified |
MBF | K222427 |
| Jun 27, 2023 | Limacorporate S.p.A REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R Open, Classified |
MBF | K222427 |
| Apr 1, 2023 | Limacorporate S.p.A SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 Open, Classified |
MBF | K163397 |
| Jan 7, 2022 | Biomet, Inc. Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long
Item Number: 113635 Terminated |
MBF | None listed |
| Jan 7, 2022 | Biomet, Inc. Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long
Item Number: 113633 Terminated |
MBF | None listed |
| Jan 7, 2022 | Biomet, Inc. Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long
Item Number: 113632 Terminated |
MBF | None listed |
| Jan 7, 2022 | Biomet, Inc. Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long
Item Number: 113631 Terminated |
MBF | None listed |
| Jan 7, 2022 | Biomet, Inc. Comprehensive Shoulder System Primary Shoulder Stem,
Micro Length, Porous Plasma, 18 MM, 55 MM Long
Item Number: 113618 Terminated |
MBF | None listed |
| Jan 7, 2022 | Biomet, Inc. Comprehensive Shoulder System Primary Shoulder Stem,
Micro Length, Porous Plasma, 14 MM, 55 MM Long
Item Number: 113614 Terminated |
MBF | None listed |
| Jan 7, 2022 | Biomet, Inc. Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long
Item Number: 113611 Terminated |
MBF | None listed |
| Jan 7, 2022 | Biomet, Inc. Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM
Item Number: 11-301301 Terminated |
MBF | None listed |
| Mar 3, 2020 | Biomet, Inc. Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive Terminated |
MBF | K060692 |
| Aug 21, 2019 | Zimmer Biomet, Inc. BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products
Item Nos. PM0000097
PM555140
PM555147
PM555319
PM555418
113867
113865
113863
Product Usage: Total Shoulder Replacement Terminated |
MBF | K043100 |
| Aug 21, 2019 | Zimmer Biomet, Inc. Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641
11-114642
11-114643
11-114644
11-114644S
11-114645
11-114646
11-114647
11-114648
11-114661
11-114662
11-114663
11-114664
11-114664S
11 Terminated |
MBF | K010635 K010827 +1 |
| Oct 10, 2018 | Zimmer Biomet, Inc. Comprehensive Mini Stem, Item No. 113631: Terminated |
MBF | K060692 |
| Jun 5, 2017 | Zimmer Biomet, Inc. COMP PRIMARY STEM 8MM MINI, model # 113628 Terminated |
MBF | K060692 |
| Jun 11, 2015 | Biomet, Inc. Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glen Terminated |
MBF | K060692 |
| Sep 4, 2009 | Encore Medical, Lp Turon Revision Glenoid Poly Liner.
The Metal Backed Revision Glenoid is a two piece metal backed polyethylene glenoid component for use in total shoulder arthroplasty. It includes a metal baseplate Terminated |
MBF | K081448 |
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