Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LZO · Predicate Candidate Screening
532 FDA 510(k) clearances under this product code; the 50 most recent screened below.
94 daysmedian FDA review time
301 days90th percentile
532clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261009 | MobileLink Acetabular Cup System – 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG | 2026-07-06 | 102 | 0 |
| K260831 | Z1 Hip System | Zimmer, Inc. | 2026-06-16 | 95 | 0 |
| K260182 | Avenir® Müller Stem; Avenir Complete™ Hip System | Zimmer, Inc. | 2026-04-27 | 96 | 0 |
| K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026-03-30 | 83 | 0 |
| K252401 | implaFit® short stems | Implantcast GmbH | 2026-03-12 | 224 | 0 |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas | Maxx Orthopedics, Inc. | 2026-01-15 | 111 | 0 |
| K250450 | Coated hip implants | Medacta International S.A. | 2025-09-19 | 213 | 0 |
| K243021 | Longboard Revision Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025-08-07 | 314 | 0 |
| K251906 | Z1 Hip System | Zimmer, Inc. | 2025-07-18 | 28 | 0 |
| K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | 2025-05-23 | 28 | 0 |
| K243927 | MobileLink Acetabular Cup System - inhouse coatings | Waldemar Link GmbH & Co. KG | 2025-05-16 | 147 | 0 |
| K250444 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | 2025-05-15 | 90 | 0 |
| K243043 | Origin™ Cemented Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025-05-02 | 217 | 0 |
| K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | 2025-04-18 | 30 | 0 |
| K250571 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | 2025-03-28 | 30 | 0 |
| K243029 | Origin™ TT Stem | Signature Orthopaedics Pty, Ltd. | 2025-03-11 | 165 | 0 |
| K241767 | Versacem Acetabular Shell and Double Mobility HC Liners | Medacta International S.A. | 2025-03-06 | 259 | 0 |
| K243809 | Biolox® Delta Revision heads | Limacorporate | 2025-03-04 | 83 | 0 |
| K241483 | ceramys™ femoral head system | Encore Medical L.P. | 2025-02-07 | 259 | 0 |
| K243466 | Conformity Stem Extension Line, #0 | United Orthopedic Corporation | 2025-01-06 | 59 | 0 |
| K243444 | BIOCERAM AZUL® HEAD | Kyocera Corporation | 2024-12-05 | 29 | 0 |
| K240528 | b-ONE® Total Hip System | B-One Ortho, Corp. | 2024-11-15 | 266 | 0 |
| K240391 | MUTARS® femoral stem cemented 160 mm and 200 mm | Implantcast GmbH | 2024-10-24 | 259 | 0 |
| K242249 | Conformity Stem Extension Line | United Orthopedic Corporation | 2024-08-30 | 30 | 0 |
| K241241 | Z1 Cemented Hip System | Orchard Medical Development, LLC | 2024-08-27 | 116 | 0 |
| K240381 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | 2024-06-27 | 140 | 0 |
| K240834 | EcoFit® short stem cementless cpTi | Implantcast GmbH | 2024-06-03 | 69 | 0 |
| K234025 | 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-04-24 | 126 | 0 |
| K240452 | Ceramic Femoral Head | Microport Orthopedics, Inc. | 2024-04-12 | 57 | 0 |
| K233724 | 28mm/38D MDM X3 Insert for MDM Liner | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-03-11 | 111 | 0 |
| K233476 | Z1 Hip System | Orchard Medical Development | 2024-02-08 | 106 | 1 |
| K223745 | Novae® Dual Mobility System, Hype® Hip System | Serf | 2023-12-22 | 373 | 0 |
| K232371 | Actinia® hip stems | Implantcast GmbH | 2023-10-19 | 72 | 0 |
| K233233 | EMPHASYS Femoral Stems | Depuy Ireland UC | 2023-10-11 | 13 | 0 |
| K231925 | MINIMA S System | Lima Corporate S.P.A. | 2023-07-11 | 11 | 0 |
| K223103 | BethaLoc® stem cementless HA | Implantcast GmbH | 2023-06-20 | 263 | 0 |
| K231109 | Xerxes Hip Stem | Xerxes Arthopedix, LLC | 2023-06-15 | 57 | 0 |
| K221323 | Exactech® Alteon® Short Tapered Wedge | Exactech, Inc. | 2023-05-19 | 378 | 0 |
| K223828 | BENCOX Delta Option Heads | Corentec Co., Ltd. | 2023-03-16 | 85 | 0 |
| K222296 | ARTICUL/EZE Ceramic Heads | Depuy Ireland UC | 2023-01-06 | 158 | 0 |
| K221149 | U-Motion II Acetabular System-Extension line | United Orthopedic Corporation | 2023-01-05 | 260 | 0 |
| K221462 | DePuy Reclaim Monobloc Revision Femoral Stem | Depuy Ireland UC | 2022-10-21 | 155 | 0 |
| K220483 | Platform® Acetabular System | Total Joint Orthopedics, Inc. | 2022-09-23 | 217 | 0 |
| K213770 | SP-CL Hip Stem and LCU Hip System | Waldemar Link GmbH & Co. KG | 2022-09-13 | 285 | 0 |
| K210678 | implaFit® hip stems | Implantcast GmbH | 2022-08-17 | 530 | 0 |
| K211891 | DM Converter - TiN coated | Medacta International S.A. | 2022-07-22 | 396 | 0 |
| K211567 | BiMobile Instruments (for BiMobile Dual Mobility System) | Waldemar Link GmbH & Co. KG | 2022-06-03 | 378 | 0 |
| K212327 | M-Vizion Monobloc | Medacta International S.A. | 2022-05-24 | 301 | 0 |
| K220405 | Amis K Long | Medacta International S.A. | 2022-04-12 | 57 | 0 |
| K213675 | MP Reconstruction System | Waldemar Link GmbH & Co. KG | 2022-04-11 | 140 | 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