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CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System

FDA 510(k) clearance K211704 · decided 2021-08-31

Clearance details

K-number
K211704
Device name
CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System
Applicant
Orthofix, Inc.
Decision
Substantially Equivalent
Date received
2021-06-03
Decision date
2021-08-31
Days to decision
89 days
Clearance type
Traditional
Product code
ODP
Device class
2
Regulation number
888.3080
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Lewisville, TX, 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
3d Cage Cervical (K253041)Fims Co., Ltd.2026-07-23
Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM (K262061)Stryker Spine2026-07-17
C.A. Medical Interbody Fusion System (K254130)C.A. Medical, LLC2026-07-08
BluEX Cervical Expandable Cage System (K260840)L&K BIOMED Co., Ltd.2026-05-16
OSTEOMNI SPINAL CAGES SYSTEM (K260850)Osteomni, Inc.2026-05-12
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (K260549)Zsfab, Inc.2026-04-24
ORIO-3D Cage System (K253260)SpineCraft2026-04-16
HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES (K260340)HC Biologics, LLC2026-04-13
MOD-C (K242303)Orthomod, LLC2026-04-01
Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (K252240)Spectrum Spine2026-03-30
Flex-Z™ Cervical Cage (K252432)Spinepoint, LLC2026-03-25
Hive™ Standalone Cervical System and Hive™ C Interbody System (K254105)NanoHive Medical, LLC2026-02-13

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
CervicalStim® (P030034/S017)Orthofix, Inc.2022-06-14
PhysioStim®, SpinalStim® (P850007/S046)Orthofix, Inc.2022-06-14
SpinalStim (P850007/S044)Orthofix, Inc.2020-03-27
CervicalStim (P030034/S015)Orthofix, Inc.2019-10-08
PhysioStim and SpinalStim (P850007/S043)Orthofix, Inc.2019-10-08
SpinalStim (P850007/S042)Orthofix, Inc.2019-07-03
PhysioStim and SpinalStim (P850007/S041)Orthofix, Inc.2019-06-18
CervicalStim (P030034/S014)Orthofix, Inc.2019-06-18