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Thoracolumbosacral Pedicle Screw System
FDA product code NKB · Class 2 · Orthopedic
286,872
Registered devices
24,647
Adverse events
181
Recalls
905
510(k) clearances
Devices with this code
The JASPER Spinal Fixation System — GBS Commonwealth Co.,Ltd.The JASPER Spinal Fixation System — GBS Commonwealth Co.,Ltd.EXPEDIUM — Medos International SàrlEXPEDIUM SFX — DEPUY SPINE, LLCEXPEDIUM — Medos International SàrlPedicle Screw — Eisertech, LLCTALKEETNA 5.5 Lumbar Pedicle Screw System — KAHTNU SURGICALXpine Spinal Fixation System — Jeil Medical CorporationStainless Steel — Seaspine Orthopedics CorporationMESA® Small Stature Spinal System — VB Spine LLCMESA® Spinal System — VB Spine LLCMomentum MIS — Ulrich Medical Usa, Inc.Mariner Outrigger — Seaspine Orthopedics CorporationStainless Steel — Seaspine Orthopedics CorporationTHUNDERBOLT Minimally Invasive Pedicle Screw Systems — Choice Spine, LPMariner — Seaspine Orthopedics CorporationNewPort — Seaspine Orthopedics CorporationMariner MIS — Seaspine Orthopedics CorporationVirata — Seaspine Orthopedics CorporationCD Horizon™ ModuLeX™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.ReLine — Nuvasive, Inc.ReLine — Nuvasive, Inc.ReLine — Nuvasive, Inc.Prodigy Pedicle Screw System — CURITEVA, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2024-02-28 | SEASPINE ORTHOPEDICS CORPORATION | Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw |
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