Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OVD — Predicate Candidate Screening
204 FDA 510(k) clearances under this product code; the 50 most recent screened below.
112 daysmedian FDA review time
239 days90th percentile
204clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261408 | SABER-XA System | Elevation Spine | 2026-08-03 | 95 | 0 |
| K261809 | Interwedge® Standalone Lateral | Foundation Surgical Group | 2026-07-31 | 60 | 0 |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tes | Kyocera Medical Technologies, Inc. | 2026-07-15 | 82 | 0 |
| K260810 | Anteralign LS coverplate | Tyber Medical, LLC | 2026-06-10 | 90 | 0 |
| K254202 | MectaLIF 3D Metal Anterior | Medacta International S.A. | 2026-05-05 | 127 | 0 |
| K253401 | SCRIPT™ Implant System | Globus Medical, Inc. | 2026-04-29 | 211 | 0 |
| K253559 | Ventana™ A Anterior Lumbar Interbody System | Spinal Elements, Inc. | 2026-02-25 | 100 | 0 |
| K251829 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2025-12-08 | 178 | 0 |
| K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ AL | Alphatec Spine | 2025-09-03 | 104 | 0 |
| K250072 | CONDUIT™ SYNFIX™ Evolution Secured Spacer System | Avalign Technologies, Inc. | 2025-07-10 | 181 | 0 |
| K251644 | ProAM ALIF System | Pro Surgical, Inc. | 2025-06-24 | 26 | 0 |
| K250845 | Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | 2025-06-18 | 90 | 0 |
| K251459 | OneLIF™ Interbody Fusion System | Novapproach Spine, LLC | 2025-06-12 | 31 | 0 |
| K243934 | Stable-L Lumbar Interbody System | Nexus Spine, LLC | 2025-04-30 | 131 | 0 |
| K243386 | Ventris Intervertebral Body Fusion Device | Acuity Surgical Devices, LLC | 2025-04-22 | 173 | 0 |
| K250603 | AxTiHA® Stand-Alone ALIF System | Innovasis | 2025-03-24 | 24 | 0 |
| K243802 | aprevo® anterior and lateral lumbar interbody fusion device, | Carlsmed, Inc. | 2025-03-17 | 96 | 0 |
| K243635 | aprevo® anterior lumbar interbody fusion device with interfi | Carlsmed, Inc. | 2024-12-13 | 18 | 0 |
| K243191 | Atlas Spine Lateral Expandable Interbody System | Atlas Spine, Inc. | 2024-11-26 | 57 | 0 |
| K241077 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2024-10-29 | 193 | 0 |
| K241992 | Catalyft™ LS Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2024-10-28 | 112 | 0 |
| K241477 | aprevo® anterior lumbar interbody fusion device with interfi | Carlsmed, Inc. | 2024-10-09 | 138 | 0 |
| K241487 | Interwedge® Standalone Lateral | Foundation Surgical Group, Inc. | 2024-10-02 | 131 | 0 |
| K241321 | Juliet® Ti LL Lumbar Interbody Device | Spineart SA | 2024-07-18 | 69 | 0 |
| K240368 | E3D™-A Interbody System | Evolution Spine | 2024-05-15 | 99 | 0 |
| K240126 | ProAM ALIF System | Pro Surgical, Inc. | 2024-05-03 | 108 | 0 |
| K240623 | Omnia Medical TiBrid™-SA System | Omnia Medical, LLC | 2024-04-24 | 50 | 0 |
| K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA) | 4Web Medical, Inc. | 2024-04-22 | 129 | 0 |
| K232432 | E3D™-A Interbody System | Evolution Spine | 2024-01-30 | 172 | 0 |
| K232123 | MectaLIF Anterior Lag Extension | Medacta International S.A. | 2023-10-18 | 93 | 0 |
| K231486 | Stable-L Standalone Lumbar Interbody System | Nexus Spine, LLC | 2023-10-12 | 142 | 0 |
| K232097 | IdentiTi ALIF Interbody Systems | Alphatec Spine, Inc. | 2023-09-25 | 74 | 1 |
| K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interb | Nexus Spine, LLC | 2023-09-18 | 28 | 0 |
| K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integr | MiRus, LLC | 2023-09-11 | 53 | 0 |
| K230894 | NuVasive Modulus ALIF System | Nu Vasive, Incorporated | 2023-06-16 | 77 | 0 |
| K230731 | Zavation ALIF System | Zavation Medical Products, LLC | 2023-06-14 | 90 | 0 |
| K230808 | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System | Kyocera Medical Technologies, Inc. | 2023-04-21 | 29 | 0 |
| K221324 | ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (AL | Camber Spine Technologies | 2023-03-30 | 328 | 0 |
| K223413 | Pisces™-SA STANDALONE ALIF Interbody System | Osseus Fusion Systems | 2023-02-10 | 93 | 0 |
| K223146 | EVOLUTION SPINE Interbody System | Evolution Spine | 2023-02-07 | 125 | 0 |
| K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion | Astura Medical | 2023-01-19 | 149 | 0 |
| K222009 | aprevo® anterior lumbar interbody fusion device with interfi | Carlsmed, Inc. | 2022-11-22 | 138 | 0 |
| K221545 | MectaLIF Anterior Extension | Medacta International S.A. | 2022-10-24 | 150 | 6 |
| K221751 | NuVasive Cohere ALIF System Intervertebral Body Fusion Devic | Nu Vasive, Incorporated | 2022-10-21 | 127 | 0 |
| K221936 | Standalone ALIF Interbody Fusion System | Eminent Spine | 2022-10-17 | 108 | 0 |
| K221447 | Southern Anterior Screw Fixated Cage (SASCA) | Southern Medical (Pty) , Ltd. | 2022-10-14 | 149 | 0 |
| K222561 | Align | Acuity Surgical Devices, LLC | 2022-09-23 | 30 | 0 |
| K220610 | SOLO-L | Aurora Spine, Inc. | 2022-05-27 | 85 | 0 |
| K220115 | ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion Syst | MiRus, LLC | 2022-05-13 | 119 | 0 |
| K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022-05-06 | 141 | 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