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Thoracolumbosacral Pedicle Screw System
FDA product code NKB · Class 2 · Orthopedic
291,764
Registered devices
24,829
Adverse events
182
Recalls
914
510(k) clearances
Devices with this code
ASTRA Spine System — SPINECRAFT, LLCASTRA Spine System — SPINECRAFT, LLCINGENIX — INGENIUMSPINE, LLCThe JASPER Spinal Fixation System — GBS Commonwealth Co.,Ltd.The JASPER Spinal Fixation System — GBS Commonwealth Co.,Ltd.XIA 3 — Stryker CorporationAccelFix Spinal Fixation System — L&K BIOMED CO. ,LTD.AccelFix Spinal Fixation System — L&K BIOMED CO. ,LTD.LnK Spinal Fixation System — L&K BIOMED CO. ,LTD.LnK/OpenLoc-L Spinal Fixation System — L&K BIOMED CO. ,LTD.MEGA PLUS MIS SPINE SYSTEM — BK MEDITECH CO.,LTD.MEGA PLUS SPINE SYSTEM — BK MEDITECH CO.,LTD.MEGA PLUS MIS SPINE SYSTEM — BK MEDITECH CO.,LTD.Hedjet System — Medyssey Co., Ltd.AccelFix Spinal Fixation System — L&K BIOMED CO. ,LTD.M.U.S.T. Pedicle Screw System — Medacta International SAPERLA ® TL — SpineArt SAHedjet System — Medyssey Co., Ltd.Hedjet System — Medyssey Co., Ltd.INNOVERSE Spinal System — CG MedTech Co.,Ltd.Newport — Seaspine, Inc.Malibu — Seaspine, Inc.Newport — Seaspine, Inc.LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. ,LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-19 | SEASPINE ORTHOPEDICS CORPORATION | The proximal thread depth of the spinal device is out of design specification. |
| 2026-05-28 | SEASPINE ORTHOPEDICS CORPORATION | Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion. |
| 2026-05-22 | Innovasis, Inc | Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque |
| 2025-09-19 | Orthofix U.S. LLC | Polyaxial screws do not meet performance standards. |
| 2025-06-30 | SPINEART SA | Cannulated fenestrated polyaxial screws may be incorrectly labeled |
| 2025-06-30 | SPINEART SA | Cannulated fenestrated polyaxial screws may be incorrectly labeled |
| 2024-10-29 | SEASPINE ORTHOPEDICS CORPORATION | Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. |
| 2024-10-29 | SEASPINE ORTHOPEDICS CORPORATION | Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. |
| 2024-08-21 | XTANT Medical Holdings, Inc | Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing |
| 2024-03-15 | SPINEART SA | Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tighte |
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