# K991267: Spine Applications for the Mayfield/Acciss Operating Arm and Optical Acciss Systems Module, Mayfield/Acciss Spine Ring a

- Pathway: 510(k) (Traditional)
- Applicant: Ohio Medical Instrument Co., Inc.
- Decided: Jul 12, 1999 after 90 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K851659 (1985). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955397: Mayfield-Acciss Workstation, Nomos Corp. (1996) Summary page 1.
- K982244: Mayfield Acciss Optical System, Ohio Medical Instrument Co., Inc. (1998) Summary page 1.
- K830332: Budde-Halo Retractor, Ohio Medical Instrument Co., Inc. (1983) Summary page 1.

## Indications for use
The MAYFIELD®/ ACCISS™ Image-guided Stereotactic Workstation and the MAYEIELD®/Optical ACCISS™ Image-guided Stereotactic Workstation (OASYS™), are indicated for use in guidance and localization in open craniotomies and in spinal surgeries. The ACCISS™ Systems are indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based mode! of the anatomy.

Source page: https://510kreport.com/device/K991267
Methodology: https://510kreport.com/methodology