FDA Product Code
FDA Product Code LZO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3353
510(k) Clearances — 535 records · page 1 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262473 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | 2026-10-01 | Special | PDF ↗ |
| K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026-09-17 | Traditional | PDF ↗ |
| K253948 | Momentum Acetabular Cup System | United Orthopedic Corporation | 2026-09-02 | Traditional | PDF ↗ |
| K261009 | MobileLink Acetabular Cup System 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG | 2026-07-06 | Traditional | PDF ↗ |
| K260831 | Z1 Hip System | Zimmer, Inc. | 2026-06-16 | Traditional | PDF ↗ |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip System | Zimmer, Inc. | 2026-04-27 | Traditional | PDF ↗ |
| K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026-03-30 | Traditional | PDF ↗ |
| K252401 | implaFit® short stems | Implantcast GmbH | 2026-03-12 | Traditional | PDF ↗ |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. | 2026-01-15 | Traditional | PDF ↗ |
| K250450 | Coated hip implants | Medacta International S.A. | 2025-09-19 | Traditional | PDF ↗ |
| K243021 | Longboard Revision Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025-08-07 | Traditional | PDF ↗ |
| K251906 | Z1 Hip System | Zimmer, Inc. | 2025-07-18 | Special | PDF ↗ |
| K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | 2025-05-23 | Special | PDF ↗ |
| K243927 | MobileLink Acetabular Cup System - inhouse coatings | Waldemar Link GmbH & Co. KG | 2025-05-16 | Traditional | PDF ↗ |
| K250444 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | 2025-05-15 | Traditional | PDF ↗ |
| K243043 | Origin Cemented Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025-05-02 | Traditional | PDF ↗ |
| K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | 2025-04-18 | Special | PDF ↗ |
| K250571 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | 2025-03-28 | Special | PDF ↗ |
| K243029 | Origin TT Stem | Signature Orthopaedics Pty, Ltd. | 2025-03-11 | Traditional | PDF ↗ |
| K241767 | Versacem Acetabular Shell and Double Mobility HC Liners | Medacta International S.A. | 2025-03-06 | Traditional | PDF ↗ |
| K243809 | Biolox® Delta Revision heads | Limacorporate | 2025-03-04 | Traditional | PDF ↗ |
| K241483 | ceramys femoral head system | Encore Medical L.P. | 2025-02-07 | Traditional | PDF ↗ |
| K243466 | Conformity Stem Extension Line, #0 | United Orthopedic Corporation | 2025-01-06 | Traditional | PDF ↗ |
| K243444 | BIOCERAM AZUL® HEAD | Kyocera Corporation | 2024-12-05 | Special | PDF ↗ |
| K240528 | b-ONE® Total Hip System | B-One Ortho, Corp. | 2024-11-15 | Traditional | PDF ↗ |
| K240391 | MUTARS® femoral stem cemented 160 mm and 200 mm | Implantcast GmbH | 2024-10-24 | Traditional | PDF ↗ |
| K242249 | Conformity Stem Extension Line | United Orthopedic Corporation | 2024-08-30 | Special | PDF ↗ |
| K241241 | Z1 Cemented Hip System | Orchard Medical Development, LLC | 2024-08-27 | Traditional | PDF ↗ |
| K240381 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | 2024-06-27 | Traditional | PDF ↗ |
| K240834 | EcoFit® short stem cementless cpTi | Implantcast GmbH | 2024-06-03 | Traditional | PDF ↗ |
| K234025 | 22.2mm BIOLOX® delta Ceramic V40 Femoral Heads | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-04-24 | Traditional | PDF ↗ |
| K240452 | Ceramic Femoral Head | Microport Orthopedics, Inc. | 2024-04-12 | Traditional | PDF ↗ |
| K233724 | 28mm/38D MDM X3 Insert for MDM Liner | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-03-11 | Traditional | PDF ↗ |
| K233476 | Z1 Hip System | Orchard Medical Development | 2024-02-08 | Traditional | PDF ↗ |
| K223745 | Novae® Dual Mobility System, Hype® Hip System | Serf | 2023-12-22 | Traditional | PDF ↗ |
| K232371 | Actinia® hip stems | Implantcast GmbH | 2023-10-19 | Traditional | PDF ↗ |
| K233233 | EMPHASYS Femoral Stems | Depuy Ireland UC | 2023-10-11 | Special | PDF ↗ |
| K231925 | MINIMA S System | Lima Corporate S.P.A. | 2023-07-11 | Special | PDF ↗ |
| K223103 | BethaLoc® stem cementless HA | Implantcast GmbH | 2023-06-20 | Traditional | PDF ↗ |
| K231109 | Xerxes Hip Stem | Xerxes Arthopedix, LLC | 2023-06-15 | Traditional | PDF ↗ |
| K221323 | Exactech® Alteon® Short Tapered Wedge | Exactech, Inc. | 2023-05-19 | Traditional | PDF ↗ |
| K223828 | BENCOX Delta Option Heads | Corentec Co., Ltd. | 2023-03-16 | Traditional | PDF ↗ |
| K222296 | ARTICUL/EZE Ceramic Heads | Depuy Ireland UC | 2023-01-06 | Traditional | PDF ↗ |
| K221149 | U-Motion II Acetabular System-Extension line | United Orthopedic Corporation | 2023-01-05 | Traditional | PDF ↗ |
| K221462 | DePuy Reclaim Monobloc Revision Femoral Stem | Depuy Ireland UC | 2022-10-21 | Traditional | PDF ↗ |
| K220483 | Platform® Acetabular System | Total Joint Orthopedics, Inc. | 2022-09-23 | Traditional | PDF ↗ |
| K213770 | SP-CL Hip Stem and LCU Hip System | Waldemar Link GmbH & Co. KG | 2022-09-13 | Traditional | PDF ↗ |
| K210678 | implaFit® hip stems | Implantcast GmbH | 2022-08-17 | Traditional | PDF ↗ |
| K211891 | DM Converter - TiN coated | Medacta International S.A. | 2022-07-22 | Traditional | PDF ↗ |
| K211567 | BiMobile Instruments (for BiMobile Dual Mobility System) | Waldemar Link GmbH & Co. KG | 2022-06-03 | Special | PDF ↗ |
| K212327 | M-Vizion Monobloc | Medacta International S.A. | 2022-05-24 | Traditional | PDF ↗ |
| K220405 | Amis K Long | Medacta International S.A. | 2022-04-12 | Traditional | PDF ↗ |
| K213675 | MP Reconstruction System | Waldemar Link GmbH & Co. KG | 2022-04-11 | Special | PDF ↗ |
| K212069 | Corin MetaFix Hip Stem | Corin U.S.A. Limited | 2022-04-07 | Traditional | PDF ↗ |
| K213839 | DePuy Corail AMT Hip Prosthesis | DePuy Orthopaedics, Inc. | 2022-01-06 | Special | PDF ↗ |
| K213129 | Restoration Modular 115mm Conical Distal Stem | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2021-12-21 | Traditional | PDF ↗ |
| K213580 | Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length | Total Joint Othopedics, Inc. | 2021-12-03 | Special | PDF ↗ |
| K210263 | Mpres Neck Preserving Stem | Medacta International S.A. | 2021-09-22 | Traditional | PDF ↗ |
| K211657 | EMPHASYS Femoral Stems | Depuy Ireland UC | 2021-08-05 | Traditional | PDF ↗ |
| K201657 | Corin Ltd. Hip Products: Trinity Acetabular System, Trinity PLUS Acetabular Shell, MetaFix Hip System, TriFit CF and TS Hip Systems, TaperFit Hip System, Revival Modular Hip System, MiniHip, Trinity Dual Mobility, MobiliT, BiPolar-i, OMNI MOD Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads | Corin, Ltd. | 2021-07-28 | Traditional | PDF ↗ |
| K203175 | POLARSTEM Cemented Femoral Stem | Smith & Nephew, Inc. | 2021-07-22 | Traditional | PDF ↗ |
| K211548 | POLARSTEM Calcar Reamer Guide | Smith & Nephew, Inc. | 2021-07-19 | Traditional | PDF ↗ |
| K203532 | BI-MENTUM ALTRX® Dual Mobility Liner | Depuy Ireland UC | 2021-04-28 | Traditional | PDF ↗ |
| K201047 | Fusion Taper System | Signature Orthopaedics Pty, Ltd. | 2021-04-16 | Traditional | PDF ↗ |
| K202768 | KOSMO Femoral Stem | B-One Ortho, Corp. | 2021-04-01 | Traditional | PDF ↗ |
| K203420 | EcoFit® Hip System | Implantcast GmbH | 2021-02-03 | Traditional | PDF ↗ |
| K201471 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2021-01-11 | Traditional | PDF ↗ |
| K202730 | Quadra-P | Medacta International S.A. | 2020-12-28 | Traditional | PDF ↗ |
| K200196 | Taperloc® Complete Hip Stems | Biomet Orthopedics | 2020-12-08 | Traditional | PDF ↗ |
| K203041 | SMS Cementless Stem | Medacta International S.A. | 2020-12-02 | Special | PDF ↗ |
| K203167 | DePuy Corail AMT Hip Prosthesis | DePuy Orthopaedics, Inc. | 2020-11-19 | Special | PDF ↗ |
| K201673 | SMS Cementless Stem | Medacta International S.A. | 2020-09-18 | Traditional | PDF ↗ |
| K192883 | Spartan Hip Stem | Signature Orthopaedics Pty, Ltd. | 2020-08-05 | Traditional | PDF ↗ |
| K193545 | Corin Optimized Positioning System (OPS) Femoral | Corin USA | 2020-08-04 | Traditional | PDF ↗ |
| K201951 | Cemented Origin Hip Stem | Signature Orthopaedics Pty, Ltd. | 2020-07-31 | Traditional | PDF ↗ |
| K200959 | Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling | Biomet UK, Ltd. | 2020-07-29 | Traditional | PDF ↗ |
| K192024 | Cemented TSI Hip Stem | Signature Orthopaedics Pty, Ltd. | 2020-06-19 | Special | PDF ↗ |
| K191816 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2020-04-29 | Traditional | PDF ↗ |
| K200007 | PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar | Microport Orthopedics, Inc. | 2020-04-25 | Traditional | PDF ↗ |
| K200112 | Zimmer Hip Joint Replacement | Zimmer GmbH | 2020-04-10 | Traditional | PDF ↗ |
| K192660 | Zimmer M/L Taper Hip Prosthesis | Zimmer, Inc. | 2020-02-28 | Traditional | PDF ↗ |
| K192683 | Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads | Biomet UK, Ltd. | 2020-02-27 | Traditional | PDF ↗ |
| K191831 | MobiliT Cup | Corin U.S.A. Limited | 2020-01-16 | Traditional | PDF ↗ |
| K193433 | AMIStem-C | Medacta International S.A. | 2020-01-09 | Special | PDF ↗ |
| K192827 | Quadra-P | Medacta International S.A. | 2020-01-06 | Traditional | PDF ↗ |
| K193050 | Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem | Zimmer GmbH | 2019-12-26 | Special | PDF ↗ |
| K192559 | Acetabular Bone Screws (for MobileLink Acetabular Cup System) | Waldemar Link GmbH & Co. KG | 2019-12-21 | Special | PDF ↗ |
| K192189 | Avenir Complete Hip System, Size 0 Coxa Vara | Zimmer, Inc. | 2019-12-18 | Traditional | PDF ↗ |
| K193030 | Avenir Muller Stem, Avenir Cemented Hip Stem | Zimmer GmbH | 2019-12-06 | Special | PDF ↗ |
| K192946 | DePuy Corail AMT Hip Prosthesis | DePuy Orthopaedics, Inc. | 2019-11-26 | Special | PDF ↗ |
| K192126 | AMIStem-P Short Neck | Medacta International S.A. | 2019-11-22 | Special | PDF ↗ |
| K190344 | DePuy Corail AMT Hip Prosthesis | Depuy(Ireland) | 2019-11-01 | Traditional | PDF ↗ |
| K190890 | Exactech Alteon Modular Dual Mobility (MDM) System | Exactech, Inc. | 2019-10-22 | Traditional | PDF ↗ |
| K191632 | PROFEMUR TL2 Stems | Microport Orthopedics, Inc. | 2019-10-07 | Traditional | PDF ↗ |
| K192416 | BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System | Zimmer GmbH | 2019-10-01 | Special | PDF ↗ |
| K192352 | MiniMAX | Medacta International S.A. | 2019-09-27 | Special | PDF ↗ |
| K191399 | BIOLOX CONTOURA Ceramic Femoral Head | Total Joint Othopedics, Inc. | 2019-08-28 | Special | PDF ↗ |
| K190704 | Signature Ceramic Femoral Head | Signature Orthopaedics Pty, Ltd. | 2019-08-28 | Traditional | PDF ↗ |
| K183684 | Libertas Taper Uncemented Femoral Stem | Maxx Orthopedics, Inc. | 2019-08-23 | Traditional | PDF ↗ |
| K183312 | Conformity Stem | United Orthopedic Corporation | 2019-08-08 | Traditional | PDF ↗ |
Product code LZO · Class II · Orthopedic. Data: openFDA.