Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HSX — Predicate Candidate Screening
114 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
239 days90th percentile
114clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260796 | Tahoe Unicondylar Knee System with TiNbN Overcoat | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2026-04-02 | 22 | 0 |
| K251771 | Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. | 2025-12-16 | 189 | 0 |
| K251834 | Persona Partial Knee | Zimmer Biomet | 2025-08-15 | 60 | 0 |
| K251618 | MOTO Partial Knee System Extension | Medacta International S.A. | 2025-07-24 | 58 | 0 |
| K251453 | Arthrex iBalance Partial Knee System | Arthrex, Inc. | 2025-07-01 | 50 | 0 |
| K241260 | ACTIFY™ Unicondylar Knee System | Globus Medical, Inc. | 2024-12-06 | 214 | 0 |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Smith & Nephew, Inc. | 2024-10-30 | 51 | 0 |
| K242746 | OvertureTi Knee Resurfacing SystemTM | Overture Orthopaedics | 2024-10-07 | 26 | 0 |
| K232114 | TRIBRID® Unicompartmental Knee System | Kyocera Medical Technologies, Inc. | 2024-04-04 | 265 | 0 |
| K221292 | Uni Knee Resurfacing System | Overture Resurfacing, Inc. | 2023-03-10 | 310 | 0 |
| K212870 | TLC Unicompartmental Knee System | Signature Orthopaedics Pty, Ltd. | 2022-06-16 | 280 | 0 |
| K220930 | Restoris Multi-Compartmental Knee System | Mako Surgical Corp. | 2022-06-02 | 63 | 0 |
| K211471 | Balanced Knee System Uni | Ortho Development Corporation | 2021-12-16 | 219 | 0 |
| K213071 | MOTOTM Partial Knee & MOTO PFJ Systems Extension | Medacta International S.A. | 2021-11-16 | 54 | 0 |
| K212307 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021-10-12 | 81 | 0 |
| K211512 | VISIONAIRE UK Patient Matched Cutting Guides | Smith & Nephew, Inc. | 2021-09-16 | 125 | 0 |
| K211895 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021-08-20 | 60 | 0 |
| K203697 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021-03-12 | 84 | 0 |
| K203341 | ACS LD Uni FB Knee System | Implantcast GmbH | 2021-01-08 | 57 | 0 |
| K203099 | Triathlon PKR System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2020-10-27 | 13 | 0 |
| K202207 | Materialise PKA Guide System | Materialise NV | 2020-10-02 | 57 | 0 |
| K200433 | iBalance UKA Tibial Tray Implant | Arthrex, Inc. | 2020-03-17 | 25 | 0 |
| K200151 | Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Righ | Zimmer, Inc. | 2020-03-17 | 55 | 0 |
| K191996 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2019-12-05 | 132 | 0 |
| K191150 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019-10-08 | 160 | 0 |
| K191211 | JOURNEY II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019-07-25 | 80 | 0 |
| K191325 | EMPOWR Partial Knee | Encore Medical L.P. | 2019-07-16 | 61 | 0 |
| K190085 | Journey II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019-02-11 | 25 | 1 |
| K183029 | MOTO Partial Knee System | Medacta International S.A. | 2019-01-30 | 90 | 0 |
| K181302 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019-01-17 | 245 | 0 |
| K173970 | Materialise PKA Guide System | Materialise NV | 2018-07-06 | 189 | 0 |
| K180612 | Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial In | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2018-06-07 | 91 | 0 |
| K172650 | Materialise PKA Guide System | Materialise NV | 2017-11-20 | 76 | 0 |
| K170344 | Tahoe Uni Knee System | Consensus Orthopedics, Inc. | 2017-10-05 | 244 | 0 |
| K161741 | GMK UNI | Medacta International S.A. | 2017-04-14 | 294 | 0 |
| K163700 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2017-03-29 | 90 | 0 |
| K162084 | MOTO Partial Knee System | Medacta International S.A. | 2017-01-03 | 160 | 0 |
| K161060 | Arthrex iBalance UKA System Vitamin E Tibial Bearing | Arthrex, Inc. | 2016-12-15 | 244 | 0 |
| K161592 | Persona Partial Knee System | Biomet, Inc. | 2016-11-03 | 147 | 0 |
| K160738 | ZUK Select Knee System | Smith & Nephew, Inc. | 2016-06-15 | 90 | 0 |
| K152315 | JOURNEY II Uni Tibial Base and Insert | Smith & Nephew, Inc. | 2015-10-28 | 72 | 0 |
| K132640 | IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | Conformis, Inc. | 2013-12-05 | 104 | 3 |
| K123380 | STRIDE UNICONDYLAR KNEE | Blue Belt Technologies, Inc. | 2013-05-31 | 211 | 2 |
| K122529 | ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURF | Zimmer, Inc. | 2012-11-16 | 88 | 0 |
| K121974 | CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | Conformis, Inc. | 2012-09-06 | 63 | 0 |
| K120262 | HLS UNI EVOLUTION & U-KNEETEC | Tornier, Inc. | 2012-07-25 | 180 | 0 |
| K112301 | ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER | Materialise NV | 2012-01-06 | 149 | 0 |
| K113038 | SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KN | Smith & Nephew, Inc. | 2012-01-05 | 85 | 0 |
| K111916 | CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM | Conformis, Inc. | 2011-09-29 | 85 | 0 |
| K102069 | JOURNEY UNICONDYLAR TIBIAL BASEPLATES | Smith & Nephew, Inc. | 2010-10-05 | 74 | 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