Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK103493	Date11 Mar 2011Cleared	StatusActive

Coverage

1 jurisdiction

United States — FDA 510(k) Active

3 recalls · 1 ongoing · FDA

- Ongoing Z-1034-2026 FDA Class II initiated 8 Dec 2025
Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.
- Terminated Z-0934-2022 FDA Class II initiated 17 Feb 2022
Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally around the axis) and not return to within acceptable distance from its prior position after the force is removed. In order to reduce deflection at the table mount location, users have tightened the hand knob screw to a degree that it is then difficult to untighten it later in the clinical workflow. Rotational movement at the table attachment point could result in HFD movement going unnoticed, which could result in a situation where surgical or medical intervention is necessary, a situation where navigation needs to be reestablished, or a situation resulting in extended time under anesthesia for the patient. It may also be difficult to loosen the mount clamp component after use, potentially leading to ergonomic injury or a workaround during equipment teardown.
- Terminated Z-3211-2017 FDA Class II initiated 14 Aug 2017
incorrect thread on thumbscrews

510(k)