Panels › Orthopedic › Product code NKB · Class 2
Thoracolumbosacral Pedicle Screw System
Regulation 888.3070
33510(k)s in 12 months (914 all time)
4recalls in 12 months (182 all time)
177recalls that name a 510(k)
Top companies in NKB
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 98 | 2 |
| Depuy Spine, Inc. | 30 | 10 |
| Nuvasive, Inc. | 9 | 31 |
| Spinal Elements, Inc. | 11 | 22 |
| Stryker Spine | 22 | 5 |
| Alphatec Spine, Inc. | 20 | 5 |
| Zimmer Biomet, Inc. | 0 | 25 |
| Globus Medical, Inc. | 24 | 0 |
| Life Spine | 22 | 0 |
| K2m | 20 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | SEASPINE ORTHOPEDICS CORPORATION SeaSpine Mariner Deformity
Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm
REF: MD1-300010-12 Open, Classified |
NKB | K211606 |
| Aug 3, 2026 | Innovasis, Inc Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System Open, Classified |
NKB | K241276 K250182 +1 |
| Jul 20, 2026 | SEASPINE ORTHOPEDICS CORPORATION SeaSpine Polyaxial Head
REF Number: 41-3010 Open, Classified |
NKB | K173882 |
| Nov 7, 2025 | Orthofix U.S. LLC Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:
1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030.
2. POLYAXIAL S Open, Classified |
NKB | K250908 |
| Aug 8, 2025 | SPINEART SA Brand Name: PERLA TL MIS
Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW
Model/Catalog Number: MPF-PS 55 45-S
Software Version: Not Applicable
Product Description: CANNULATED FENESTRATED POLYAXI Open, Classified |
NKB | K203506 |
| Aug 8, 2025 | SPINEART SA Brand Name: PERLA TL MIS
Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW
Model/Catalog Number: MPF-PS 65 40-S
Software Version: Not Applicable
Product Description: CANNULATED FENESTRATED POLYAXI Open, Classified |
NKB | K203506 |
| Dec 23, 2024 | SEASPINE ORTHOPEDICS CORPORATION Brand Name: Daytona Small Stature
Product Name: Ti Locking Cap 4.5mm, Small Stature, T25
Model/Catalog Number: 79-0001
Software Version: N/A
Product Description: Locking Cap
Component: No Open, Classified |
NKB | K232566 |
| Dec 23, 2024 | SEASPINE ORTHOPEDICS CORPORATION Brand Name: Daytona Small Stature
Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT
Model/Catalog Number: 79-0002
Software Version: N/A
Product Description: Locking Cap
Component: No Open, Classified |
NKB | K232566 |
| Oct 17, 2024 | XTANT Medical Holdings, Inc Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045 Open, Classified |
NKB | K221403 |
| May 3, 2024 | SPINEART SA PERLA TL 25D SCREW REF:
TLF-DS 45 25-S
TLF-DS 45 30-S
TLF-DS 45 35-S
TLF-DS 45 40-S
TLF-DS 45 45-S
TLF-DS 55 30-S
TLF-DS 55 35-S
TLF-DS 55 40-S
TLF-DS 55 45-S
TLF-DS 65 35-S
TLF-DS 65 40-S
TLF-DS 65 Open, Classified |
NKB | K193396 |
| Apr 23, 2024 | SEASPINE ORTHOPEDICS CORPORATION Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems. Open, Classified |
NKB | K222110 |
| Apr 22, 2024 | SEASPINE ORTHOPEDICS CORPORATION Mariner RDX Polyaxial Head, REF: MX1-000020;
Mariner RDX Extended Polyaxial Head, REF: MX1-000030;
Mariner RDX Deformity Head, REF: MX1-000040;
Mariner RDX Extended Deformity Head, REF: MX1-000050;
Ma Open, Classified |
NKB | K222110 |
| Jan 29, 2024 | XTANT Medical Holdings, Inc Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length. Open, Classified |
NKB | K221403 |
| Jan 4, 2024 | Zimmer Biomet Spine Inc. Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System Open, Classified |
NKB | K150896 |
| Dec 19, 2022 | Icotec Ag VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 Terminated |
NKB | K190545 K193423 +1 |
| Dec 5, 2022 | Integrity Implants Inc. LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped Terminated |
NKB | K203367 |
| Dec 5, 2022 | Integrity Implants Inc. LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shi Terminated |
NKB | K203367 |
| Dec 5, 2022 | Integrity Implants Inc. LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545.
Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation Terminated |
NKB | K203367 |
| Dec 5, 2022 | Integrity Implants Inc. LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and Terminated |
NKB | K203367 |
| Jul 15, 2022 | Aesculap Implant Systems LLC Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine.
Article Number: 52758014 Open, Classified |
NKB | K180433 |
| Jun 3, 2022 | SAFE ORTHOPAEDICS LLC SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers
KITM640, KITM645, and KITM740. Completed |
NKB | K201648 |
| Apr 9, 2021 | SPINEART SA PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Models:
PERLA TL Lateral Con Terminated |
NKB | K193396 |
| Nov 17, 2020 | Zimmer Biomet, Inc. Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system Terminated |
NKB | K140123 |
| Sep 8, 2020 | Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery. Terminated |
NKB | K062012 |
| Sep 8, 2020 | Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery. Terminated |
NKB | K062012 |
| Sep 8, 2020 | Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery. Terminated |
NKB | K062012 |
| Sep 8, 2020 | Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery. Terminated |
NKB | K062012 |
| Sep 8, 2020 | Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery. Terminated |
NKB | K062012 |
| Sep 8, 2020 | Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery. Terminated |
NKB | K062012 |
| Jul 6, 2020 | OrthoPediatrics Corp Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and
stabilization of the posterior, non-cervical spine in skeletally mature pati Open, Classified |
NKB | K150600 |
| May 26, 2020 | U&I CORP. ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM Terminated |
NKB | K173524 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X40MM, Item Number 810M7540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | K183550 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM, Item Number 811M8560 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, poste Terminated |
NKB | K183550 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number 811M8555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, poste Terminated |
NKB | K183550 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X50MM, Item Number 811M8550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, poste Terminated |
NKB | K183550 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X45MM, Item Number 811M8545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, poste Terminated |
NKB | K183550 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X40MM, Item Number 811M8540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, poste Terminated |
NKB | K183550 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X55MM, Item Number 810M7555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | K183550 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X50MM, Item Number 810M7550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | K183550 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM, Item Number 810M7545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | K183550 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM, Item Number 810M6540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | K183550 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X35MM, Item Number 810M7535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | K183550 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Number 810M6555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | K183550 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X50MM, Item Number 810M6550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | K183550 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Number 810M6545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | K183550 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Number 810M6535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | K183550 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM, Item Number 810M5555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | K183550 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number 810M5550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | K183550 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Number 810M5545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | K183550 |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X40MM, Item Number 810M5540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | K182550 |
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