Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MAX — Predicate Candidate Screening
895 FDA 510(k) clearances under this product code; the 50 most recent screened below.
106 daysmedian FDA review time
261 days90th percentile
895clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261430 | TruLift Expandable System | Life Spine, Inc. | 2026-07-28 | 89 | 0 |
| K253011 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2026-07-17 | 301 | 0 |
| K261020 | Symmetrix™ L Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026-07-14 | 109 | 0 |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; | SeaSpine Orthopedics Corporation | 2026-07-01 | 273 | 0 |
| K253151 | Fule Interbody Fusion Cage System | Beijing Fule Science & Technology Development Co., Ltd. | 2026-06-15 | 262 | 0 |
| K261159 | Exceed® Biplanar Expandable Interbody System | Spine Wave, Inc. | 2026-05-29 | 51 | 0 |
| K253894 | BMD Titanium Spinal Fusion System | Global Biomedica s.r.o. | 2026-05-28 | 175 | 0 |
| K260506 | Ventana® P/T Lumbar Interbody System | Spinal Elements, Inc. | 2026-05-15 | 87 | 0 |
| K260837 | VersaLift Expandable System | Life Spine, Inc. | 2026-05-12 | 60 | 0 |
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo | Carlsmed, Inc. | 2026-05-09 | 92 | 0 |
| K261067 | BEE PLIF Cage | NGMedical GmbH | 2026-04-30 | 29 | 0 |
| K254017 | SWINGO-3D Lumbar Cage System | Implanet | 2026-02-26 | 73 | 0 |
| K253583 | LUX Expandable Lumbar Interbody System | Xenix Medical | 2026-02-23 | 98 | 0 |
| K250773 | Luna® Ti Interbody Fusion System | Spinal Elements, Inc. | 2026-02-04 | 327 | 0 |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fix | Life Spine, Inc. | 2026-01-23 | 59 | 0 |
| K253266 | Titanium Interbody System | Spine Innovation, LLC | 2026-01-08 | 101 | 0 |
| K253577 | IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant I | Medicrea International S.A.S. (Medtronic) | 2025-12-19 | 32 | 0 |
| K252610 | ZSFab Lumbar Interbody System | Zsfab, Inc. | 2025-11-25 | 99 | 0 |
| K252351 | UniSpace® TPLIF Cage | Cg Medtech Co., Ltd. | 2025-10-28 | 91 | 0 |
| K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | 2025-10-24 | 24 | 0 |
| K251479 | Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumba | Mobarn Medical Devices, LLC | 2025-09-18 | 128 | 0 |
| K251444 | Endoskeleton™ Interbody Systems | Medtronic Sofamor Danek USA, Inc. | 2025-09-04 | 118 | 0 |
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody | Atlas Spine, Inc. | 2025-08-15 | 50 | 0 |
| K252113 | PRADO™ Lumbar Interbody Fusion System | Bethesda Medical Devices | 2025-08-05 | 29 | 0 |
| K251016 | MectaLIF 3D Metal | Medacta International S.A. | 2025-07-17 | 106 | 0 |
| K251741 | PathLoc Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2025-07-08 | 32 | 0 |
| K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate | Life Spine, Inc. | 2025-07-07 | 53 | 0 |
| K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lat | Carlsmed, Inc. | 2025-07-07 | 111 | 0 |
| K250987 | aprevo® posterior/transforaminal lumbar interbody fusion dev | Carlsmed, Inc. | 2025-06-30 | 91 | 0 |
| K243816 | Testa TP Pivoting Spacer System | Spine Wave, Inc. | 2025-06-27 | 197 | 0 |
| K251003 | X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | 2025-06-25 | 85 | 0 |
| K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Ex | Expanding Innovations, Inc. | 2025-06-16 | 20 | 0 |
| K243973 | FIX-L PEEK PLIF and T-PLIF System | Jeil Medical Corporation | 2025-06-12 | 171 | 0 |
| K251335 | Tera Lumbar Interbody Fusion System (Various PNs) | Acuity Surgical Devices, LLC | 2025-06-02 | 33 | 0 |
| K243116 | FlareHawk Interbody Fusion System | Integrity Implants Inc. Dba Accelus | 2025-05-21 | 233 | 0 |
| K250669 | Adaptix™ Interbody System with Titan nanoLOCK™ Surface Techn | Medtronic Sofamor Danek USA, Inc. | 2025-04-22 | 48 | 0 |
| K250373 | ProLift Expandable Spacer System | Life Spine, Inc. | 2025-04-09 | 58 | 0 |
| K243074 | Spectrum Spine Lumbar Cage System | Spectrum Spine, Inc. | 2025-04-04 | 189 | 0 |
| K250667 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2025-04-04 | 30 | 0 |
| K250186 | GoLIF! Lumbar Interbody Fusion System | Getset Surgical, SA | 2025-03-21 | 58 | 0 |
| K242771 | Tesera-k PL System and Tesera-k XL System | Kyocera Medical Technologies, Inc. | 2025-03-20 | 188 | 0 |
| K241783 | FortiVy™ OsteoVy™ Lumbar IBF | Vy Spine, LLC | 2025-03-18 | 271 | 0 |
| K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interb | Alphatec Spine | 2025-02-03 | 264 | 0 |
| K243739 | AxCess® Expandable Interbody System | Elliquence, LLC | 2025-01-24 | 51 | 0 |
| K243668 | ProLift Pivot Expandable Spacer System | Life Spine, Inc. | 2025-01-23 | 57 | 0 |
| K243670 | Idys® LIF | Clariance | 2024-12-31 | 34 | 0 |
| K241073 | DZ-Tabone Intervertebral Body Fusion Device | Shenzhen Dazhou Medical Technology Co., Ltd. | 2024-12-06 | 231 | 0 |
| K242829 | BluEX Lumbar Expandable Cage System | L&K BIOMED Co., Ltd. | 2024-10-23 | 34 | 0 |
| K242589 | Scarlet® AL-T | Spineart SA | 2024-10-23 | 54 | 0 |
| K233947 | KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System | Ctl Medical Corporation | 2024-10-10 | 301 | 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