Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
NKB — Predicate Candidate Screening
905 FDA 510(k) clearances under this product code; the 50 most recent screened below.
76 daysmedian FDA review time
218 days90th percentile
905clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253943 | Tiger 2 System | Zavation Medical Products, LLC | 2026-07-24 | 226 | 0 |
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET S | MANTIZ Co., Ltd. | 2026-07-24 | 170 | 0 |
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2. | Alphatec Spine, Inc. | 2026-07-14 | 88 | 0 |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific | S.M.A.I.O | 2026-07-01 | 215 | 0 |
| K253045 | “Socko” Vimax Spinal Fixation System | Socko Medical Co., Ltd. | 2026-06-17 | 268 | 0 |
| K251251 | ChanPin Pedicle Screw Spinal System | Chanpin Medtak Co., Ltd. | 2026-06-09 | 412 | 0 |
| K260989 | Varion Thoracolumbar Fixation System | Kyocera Medical Technologies Inc. (KMTI) | 2026-05-15 | 51 | 0 |
| K253739 | SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilizat | Globus Medical, Inc. | 2026-05-07 | 164 | 0 |
| K261130 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2026-05-05 | 29 | 0 |
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | 2026-05-01 | 141 | 0 |
| K252542 | LEO Spinal System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-29 | 260 | 0 |
| K253940 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2026-04-28 | 140 | 0 |
| K260216 | CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ Modu | Medtronic Sofamor Danek USA, Inc. | 2026-04-21 | 88 | 0 |
| K254274 | ARx® SAI Implant System | Life Spine, Inc. | 2026-04-16 | 107 | 0 |
| K260786 | KHEIRON® Spinal Fixation System, including patient specific | S.M.A.I.O | 2026-04-03 | 24 | 0 |
| K254247 | OSTEOMNI SPINAL FIXATION SYSTEM | Osteomni, Inc. | 2026-02-24 | 57 | 0 |
| K253169 | Duet™ Spinal Fixation System | Box Spine, LLC | 2026-02-23 | 150 | 0 |
| K253545 | Vulcan Spinal System | K2m, Inc. | 2026-02-10 | 88 | 0 |
| K252461 | Swedge™ Pedicle Screw Fixation System Bezier Rod | Spinal Resources, Inc. | 2026-01-13 | 161 | 0 |
| K253941 | CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) | Medtronic Sofamor Danek USA, Inc. | 2026-01-07 | 29 | 0 |
| K253990 | KHEIRON® Spinal Fixation System, including patient specific | S.M.A.I.O | 2026-01-07 | 26 | 0 |
| K253093 | Vital™ Spinal Fixation System | Highridge Medical, LLC | 2025-12-17 | 85 | 0 |
| K253721 | KHEIRON® Spinal Fixation System, including patient specific | S.M.A.I.O | 2025-12-17 | 23 | 0 |
| K252729 | Universal Spinal System | Double Medical Technology, Inc. | 2025-11-18 | 82 | 0 |
| K252730 | Fule Spinal Fixation System | Beijing Fule Science & Technology Development Co., Ltd. | 2025-10-24 | 57 | 0 |
| K253335 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 | 24 | 0 |
| K253249 | TriALTIS™ Spine System | Medos International SARL | 2025-10-21 | 22 | 0 |
| K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spi | Astura Medical | 2025-10-21 | 85 | 0 |
| K242827 | A8 INTEGR8™ Porous Pedicle Screws | Allumin8, Inc. | 2025-10-20 | 397 | 0 |
| K253331 | PressON Spinal Fixation System | Nexus Spine | 2025-10-14 | 14 | 0 |
| K252437 | JAZZ Spinal System | Implanet | 2025-08-28 | 27 | 0 |
| K251804 | KHEIRON® Spinal Fixation System, including patient specific | S.M.A.I.O | 2025-07-08 | 26 | 0 |
| K251719 | Momentum® Posterior Spinal Fixation System | Ulrich Medical USA, Inc. | 2025-07-01 | 27 | 0 |
| K250908 | Virata Spinal Fixation System | SeaSpine Orthopedics Corporation | 2025-06-18 | 84 | 1 |
| K251154 | RIVA Posterior Fixation System; RIVA Posterior Fixation Syst | Ht Medical D.B.A. Xenix Medical | 2025-06-12 | 59 | 0 |
| K251131 | Annex® 2 Adjacent Level System | Spine Wave, Inc. | 2025-06-06 | 56 | 0 |
| K250582 | COLONNADE Posterior Screw Fixation System | CG Bio Co., Ltd. | 2025-05-08 | 70 | 0 |
| K241663 | Eminent Spine 3D Titanium Pedicle Screw System | Eminent Spine | 2025-04-28 | 325 | 0 |
| K250092 | HC Biologics Osteopoint Spinal Fixation System | HC Biologics, LLC | 2025-03-27 | 72 | 0 |
| K242900 | VADER® Pedicle System and VADER®one Pedicle System | Icotec AG | 2025-02-27 | 157 | 0 |
| K243916 | Primus Spinal Fixation System | Spinal Elements, Inc. | 2025-02-21 | 63 | 0 |
| K243908 | Tiger 2 System | Zavation Medical Products, LLC | 2025-02-03 | 46 | 0 |
| K243249 | TriALTIS™ Spine System | Medos International SARL | 2025-01-17 | 98 | 0 |
| K243946 | EffortMed Spinal Fixation System | Effortmed, LLC | 2025-01-15 | 26 | 0 |
| K243259 | MASADA Modular Spinal Fixation System | Astura Medical | 2025-01-07 | 84 | 0 |
| K243693 | NEO Pedicle Screw System™ | Neo Medical SA | 2024-12-23 | 24 | 0 |
| K242297 | Reform Pedicle Screw System | Precision Spine, Inc. | 2024-12-17 | 137 | 0 |
| K243281 | LOCK-IN Spinal Fixation System | Lock-In USA Corp | 2024-12-13 | 57 | 0 |
| K231655 | 4CIS® Chiron Spinal Fixation System | Solco Biomedical Co., Ltd. | 2024-11-26 | 539 | 0 |
| K242764 | MediRod Pedicle Screw System | Cmf Medicon Surgical, Inc. | 2024-11-13 | 61 | 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