Atlas FDA

XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi

FDA 510(k) clearance K222684 · decided 2023-06-08

Clearance details

K-number
K222684
Device name
XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi
Applicant
Stryker Spine
Decision
Substantially Equivalent
Date received
2022-09-06
Decision date
2023-06-08
Days to decision
275 days
Clearance type
Traditional
Product code
NKB
Device class
2
Regulation number
888.3070
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Allendale, NJ, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Tiger 2 System (K253943)Zavation Medical Products, LLC2026-07-24
QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) (K260362)MANTIZ Co., Ltd.2026-07-24
Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (K261284)Alphatec Spine, Inc.2026-07-14
KHEIRON® Spinal Fixation System, including patient specific K-ROD (K253802)S.M.A.I.O2026-07-01
“Socko” Vimax Spinal Fixation System (K253045)Socko Medical Co., Ltd.2026-06-17
ChanPin Pedicle Screw Spinal System (K251251)Chanpin Medtak Co., Ltd.2026-06-09
Varion Thoracolumbar Fixation System (K260989)Kyocera Medical Technologies Inc. (KMTI)2026-05-15
SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System (K253739)Globus Medical, Inc.2026-05-07
AccelFix Spinal Fixation System (K261130)L&K BIOMED Co., Ltd.2026-05-05
PERLA® TL Posterior Thoraco-lumbar Fixation System (K253966)Spineart SA2026-05-01
LEO Spinal System (K252542)ZheJiang Decans Medical Devices Co., Ltd.2026-04-29
M.U.S.T. Pedicle Screw System - Extension (K253940)Medacta International S.A.2026-04-28

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
RAY TFC AND RAY TFC UNITE (P950019/S014)Stryker Spine2004-03-25
RAY TFC UNITE (P950019/S016)Stryker Spine2003-10-10
RAY THREADED FUSION CAGE (TFC) (P950019/S015)Stryker Spine2003-09-04
RAY TFC UNITE PRODUCT LINE (P950019/S013)Stryker Spine2003-07-15
RAY TFC DEVICE/RAY TFC UNITE DEVICE (P950019/S012)Stryker Spine2002-04-02
RAY THREADED FUSION CAGE(TFC-TM) DEVICE WITH INSTRUMENTATION (P950019/S011)Stryker Spine2000-03-30
RAY TFC DEVICE AND RAY TFC UNITE DEVICE (P950019/S009)Stryker Spine2000-03-02
RAY THREADED FUSION CAGE(TFC) (P950019/S010)Stryker Spine1999-12-01