PYXIS 3D Titanium Cervical Cage System
GS Medical Co., Ltd. · Model 8071-1207S · UDI-DI 08809974829103
Description
The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the height of the intervertebral space after resection of the disc. The intervertebral body fusion devices are made of 3D printed titanium alloy (Ti-6Al-4V) in accordance with and manufactured as per ASTM F3001. The material and manufacturing process of the subject device, PYXIS 3D Titanium Cervical Cage is identical to the additional predicate (PYXIS 3D Titanium Cage System, K223868). The PYXIS 3D Titanium Cervical Cage System implants are available in various heights, footprints, and lordotic angles to suit the individual patient’s pathology and anatomical conditions. The subject device cages ranging in height from 5mm-10mm in 1 mm increments with 0°, 4°, and 8° options. Also in 4.5mm hight for the 0° angle. The cages are provided in three distinct footprints.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
| 2025-10-29 | Medicrea International | Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. |
| 2025-10-29 | Medicrea International | Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. |
| 2025-09-16 | Medtronic Sofamor Danek USA Inc | Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical techni |
| 2025-08-06 | SEASPINE ORTHOPEDICS CORPORATION | Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may le |
| 2025-06-24 | Orthofix U.S. LLC | A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap infor |
| 2025-02-20 | Orthofix U.S. LLC | The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm. |
| 2024-12-15 | Alphatec Spine, Inc. | Complaints have been received regarding post-operative implant collapse. |
| 2024-08-14 | Innovasis, Inc | Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device. |
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