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 |
|---|---|---|---|
| May 24, 2022 | K212327 | M-Vizion Monobloc Medacta International S.A., CH | LZO |
| Apr 12, 2022 | K220405 | Amis K Long Medacta International S.A., CH | LZO |
| Apr 11, 2022 | K213675 | MP Reconstruction System Waldemar Link GmbH & Co. KG, DE | LZO |
| Apr 7, 2022 | K212069 | Corin MetaFix Hip Stem Corin U.S.A. Limited | LZO |
| Jan 6, 2022 | K213839 | DePuy Corail AMT Hip Prosthesis DePuy Orthopaedics, Inc. | LZO |
| Dec 21, 2021 | K213129 | Restoration Modular 115mm Conical Distal Stem Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LZO |
| Dec 3, 2021 | K213580 | Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length Total Joint Othopedics, Inc. | LZO |
| Sep 22, 2021 | K210263 | Mpres Neck Preserving Stem Medacta International S.A., CH | LZO |
| Aug 5, 2021 | K211657 | EMPHASYS Femoral Stems Depuy Ireland UC, IE | LZO |
| Jul 28, 2021 | K201657 | Corin Ltd. Hip Products: Trinity Acetabular System, Trinity PLUS Acetabular Shell, MetaFix Hip System, TriFit CF and Corin, Ltd. | LZO |
| Jul 22, 2021 | K203175 | POLARSTEM Cemented Femoral Stem Smith & Nephew, Inc. | LZO |
| Jul 19, 2021 | K211548 | POLARSTEM Calcar Reamer Guide Smith & Nephew, Inc. | LZO |
| Apr 28, 2021 | K203532 | BI-MENTUM ALTRX® Dual Mobility Liner Depuy Ireland UC, IE | LZO |
| Apr 16, 2021 | K201047 | Fusion Taper System Signature Orthopaedics Pty, Ltd., AU | LZO |
| Apr 1, 2021 | K202768 | KOSMO Femoral Stem B-One Ortho, Corp. | LZO |
| Feb 3, 2021 | K203420 | EcoFit® Hip System Implantcast GmbH, DE | LZO |
| Jan 11, 2021 | K201471 | M-Vizion Femoral Revision System Extension Medacta International S.A., CH | LZO |
| Dec 28, 2020 | K202730 | Quadra-P Medacta International S.A., CH | LZO |
| Dec 8, 2020 | K200196 | Taperloc® Complete Hip Stems Biomet Orthopedics | LZO |
| Dec 2, 2020 | K203041 | SMS Cementless Stem Medacta International S.A., CH | LZO |
| Nov 19, 2020 | K203167 | DePuy Corail AMT Hip Prosthesis DePuy Orthopaedics, Inc. | LZO |
| Sep 18, 2020 | K201673 | SMS Cementless Stem Medacta International S.A., CH | LZO |
| Aug 5, 2020 | K192883 | Spartan Hip Stem Signature Orthopaedics Pty, Ltd., AU | LZO |
| Aug 4, 2020 | K193545 | Corin Optimized Positioning System (OPS) Femoral Corin USA | LZO |
| Jul 31, 2020 | K201951 | Cemented Origin Hip Stem Signature Orthopaedics Pty, Ltd., AU | LZO |
| Jul 29, 2020 | K200959 | Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling Biomet UK, Ltd., GB | LZO |
| Jun 19, 2020 | K192024 | Cemented TSI Hip Stem Signature Orthopaedics Pty, Ltd., AU | LZO |
| Apr 29, 2020 | K191816 | M-Vizion Femoral Revision System Extension Medacta International S.A., CH | LZO |
| Apr 25, 2020 | K200007 | PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar Microport Orthopedics, Inc. | LZO |
| Apr 10, 2020 | K200112 | Zimmer Hip Joint Replacement Zimmer GmbH, CH | LZO |
| Feb 28, 2020 | K192660 | Zimmer M/L Taper Hip Prosthesis Zimmer, Inc. | LZO |
| Feb 27, 2020 | K192683 | Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads Biomet UK, Ltd., GB | LZO |
| Jan 16, 2020 | K191831 | MobiliT Cup Corin U.S.A. Limited | LZO |
| Jan 9, 2020 | K193433 | AMIStem-C Medacta International S.A., CH | LZO |
| Jan 6, 2020 | K192827 | Quadra-P Medacta International S.A., CH | LZO |
| Dec 26, 2019 | K193050 | Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem Zimmer GmbH, CH | LZO |
| Dec 21, 2019 | K192559 | Acetabular Bone Screws (for MobileLink Acetabular Cup System) Waldemar Link GmbH & Co. KG, DE | LZO |
| Dec 18, 2019 | K192189 | Avenir Complete Hip System, Size 0 Coxa Vara Zimmer, Inc. | LZO |
| Dec 6, 2019 | K193030 | Avenir Muller Stem, Avenir Cemented Hip Stem Zimmer GmbH, CH | LZO |
| Nov 26, 2019 | K192946 | DePuy Corail AMT Hip Prosthesis DePuy Orthopaedics, Inc. | LZO |
| Nov 22, 2019 | K192126 | AMIStem-P Short Neck Medacta International S.A., CH | LZO |
| Nov 1, 2019 | K190344 | DePuy Corail AMT Hip Prosthesis Depuy(Ireland), IE | LZO |
| Oct 22, 2019 | K190890 | Exactech Alteon Modular Dual Mobility (MDM) System Exactech, Inc. | LZO |
| Oct 7, 2019 | K191632 | PROFEMUR TL2 Stems Microport Orthopedics, Inc. | LZO |
| Oct 1, 2019 | K192416 | BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System Zimmer GmbH, CH | LZO |
| Sep 27, 2019 | K192352 | MiniMAX Medacta International S.A., CH | LZO |
| Aug 28, 2019 | K191399 | BIOLOX CONTOURA Ceramic Femoral Head Total Joint Othopedics, Inc. | LZO |
| Aug 28, 2019 | K190704 | Signature Ceramic Femoral Head Signature Orthopaedics Pty, Ltd., AU | LZO |
| Aug 23, 2019 | K183684 | Libertas Taper Uncemented Femoral Stem Maxx Orthopedics, Inc. | LZO |
| Aug 8, 2019 | K183312 | Conformity Stem United Orthopedic Corporation, TW | LZO |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.