Panels › Orthopedic › Product code LZO · Class 2
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation 888.3353
9510(k)s in 12 months (535 all time)
0recalls in 12 months (177 all time)
168recalls that name a 510(k)
Top companies in LZO
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer GmbH | 34 | 35 |
| Stryker Howmedica Osteonics | 0 | 51 |
| Medacta International | 38 | 0 |
| Exactech, Inc. | 21 | 15 |
| Corin U.S.A. Limited | 27 | 5 |
| Biomet, Inc. | 21 | 8 |
| Howmedica Osteonics | 24 | 2 |
| Smith & Nephew, Inc. | 24 | 2 |
| Microport Orthopedics, Inc. | 13 | 8 |
| Howmedica Corp. | 19 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 1, 2026 | K262473 | NEXUS® Hip Stem Microport Orthopedics, Inc. | LZO |
| Sep 17, 2026 | K260173 | M-Vizion Femoral Revision System Extension Medacta International S.A., CH | LZO |
| Sep 2, 2026 | K253948 | Momentum Acetabular Cup System United Orthopedic Corporation, TW | LZO |
| Jul 6, 2026 | K261009 | MobileLink Acetabular Cup System 40mm ID Inserts (various) Waldemar Link GmbH & Co. KG, DE | LZO |
| Jun 16, 2026 | K260831 | Z1 Hip System Zimmer, Inc. | LZO |
| Apr 27, 2026 | K260182 | Avenir® Müller Stem; Avenir Complete Hip System Zimmer, Inc. | LZO |
| Mar 30, 2026 | K260037 | implantcast Packaging System Update Implantcast GmbH, DE | LZO |
| Mar 12, 2026 | K252401 | implaFit® short stems Implantcast GmbH, DE | LZO |
| Jan 15, 2026 | K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) Maxx Orthopedics, Inc. | LZO |
| Sep 19, 2025 | K250450 | Coated hip implants Medacta International S.A., CH | LZO |
| Aug 7, 2025 | K243021 | Longboard Revision Hip Stem Signature Orthopaedics Pty, Ltd., AU | LZO |
| Jul 18, 2025 | K251906 | Z1 Hip System Zimmer, Inc. | LZO |
| May 23, 2025 | K251292 | RECLAIM Monobloc Revision Femoral Stem Depuy Ireland UC, IE | LZO |
| May 16, 2025 | K243927 | MobileLink Acetabular Cup System - inhouse coatings Waldemar Link GmbH & Co. KG, DE | LZO |
| May 15, 2025 | K250444 | NEXUS® Hip Stem Microport Orthopedics, Inc. | LZO |
| May 2, 2025 | K243043 | Origin Cemented Hip Stem Signature Orthopaedics Pty, Ltd., AU | LZO |
| Apr 18, 2025 | K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) Zimmer Biomet | LZO |
| Mar 28, 2025 | K250571 | CATALYSTEM Femoral Stems Smith & Nephew, Inc. | LZO |
| Mar 11, 2025 | K243029 | Origin TT Stem Signature Orthopaedics Pty, Ltd., AU | LZO |
| Mar 6, 2025 | K241767 | Versacem Acetabular Shell and Double Mobility HC Liners Medacta International S.A., CH | LZO |
| Mar 4, 2025 | K243809 | Biolox® Delta Revision heads Limacorporate, IT | LZO |
| Feb 7, 2025 | K241483 | ceramys femoral head system Encore Medical L.P. | LZO |
| Jan 6, 2025 | K243466 | Conformity Stem Extension Line, #0 United Orthopedic Corporation, TW | LZO |
| Dec 5, 2024 | K243444 | BIOCERAM AZUL® HEAD Kyocera Corporation, JP | LZO |
| Nov 15, 2024 | K240528 | b-ONE® Total Hip System B-One Ortho, Corp. | LZO |
| Oct 24, 2024 | K240391 | MUTARS® femoral stem cemented 160 mm and 200 mm Implantcast GmbH, DE | LZO |
| Aug 30, 2024 | K242249 | Conformity Stem Extension Line United Orthopedic Corporation, TW | LZO |
| Aug 27, 2024 | K241241 | Z1 Cemented Hip System Orchard Medical Development, LLC | LZO |
| Jun 27, 2024 | K240381 | CATALYSTEM Femoral Stems Smith & Nephew, Inc. | LZO |
| Jun 3, 2024 | K240834 | EcoFit® short stem cementless cpTi Implantcast GmbH, DE | LZO |
| Apr 24, 2024 | K234025 | 22.2mm BIOLOX® delta Ceramic V40 Femoral Heads Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LZO |
| Apr 12, 2024 | K240452 | Ceramic Femoral Head Microport Orthopedics, Inc. | LZO |
| Mar 11, 2024 | K233724 | 28mm/38D MDM X3 Insert for MDM Liner Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LZO |
| Feb 8, 2024 | K233476 | Z1 Hip System Orchard Medical Development | LZO |
| Dec 22, 2023 | K223745 | Novae® Dual Mobility System, Hype® Hip System Serf, FR | LZO |
| Oct 19, 2023 | K232371 | Actinia® hip stems Implantcast GmbH, DE | LZO |
| Oct 11, 2023 | K233233 | EMPHASYS Femoral Stems Depuy Ireland UC, IE | LZO |
| Jul 11, 2023 | K231925 | MINIMA S System Lima Corporate S.P.A., IT | LZO |
| Jun 20, 2023 | K223103 | BethaLoc® stem cementless HA Implantcast GmbH, DE | LZO |
| Jun 15, 2023 | K231109 | Xerxes Hip Stem Xerxes Arthopedix, LLC | LZO |
| May 19, 2023 | K221323 | Exactech® Alteon® Short Tapered Wedge Exactech, Inc. | LZO |
| Mar 16, 2023 | K223828 | BENCOX Delta Option Heads Corentec Co., Ltd., KR | LZO |
| Jan 6, 2023 | K222296 | ARTICUL/EZE Ceramic Heads Depuy Ireland UC, IE | LZO |
| Jan 5, 2023 | K221149 | U-Motion II Acetabular System-Extension line United Orthopedic Corporation, TW | LZO |
| Oct 21, 2022 | K221462 | DePuy Reclaim Monobloc Revision Femoral Stem Depuy Ireland UC, IE | LZO |
| Sep 23, 2022 | K220483 | Platform® Acetabular System Total Joint Orthopedics, Inc. | LZO |
| Sep 13, 2022 | K213770 | SP-CL Hip Stem and LCU Hip System Waldemar Link GmbH & Co. KG, DE | LZO |
| Aug 17, 2022 | K210678 | implaFit® hip stems Implantcast GmbH, DE | LZO |
| Jul 22, 2022 | K211891 | DM Converter - TiN coated Medacta International S.A., CH | LZO |
| Jun 3, 2022 | K211567 | BiMobile Instruments (for BiMobile Dual Mobility System) Waldemar Link GmbH & Co. KG, DE | LZO |
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