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General product and regulatory information only. This page is not medical advice and does not describe how a halo is fitted, adjusted or removed; those decisions belong to the treating clinical team.
Short answer
A halo vest is a cervical spine immobilization system. A ring is held to the skull by four pins and is connected by rods to a vest worn on the trunk, so the neck is held still while the jaw stays free. In the US, halo rings have been cleared by FDA under 21 CFR 882.5960 (product code HAX), a Class II device type.
Definition and scope
A case report in the International Journal of Spine Surgery describes the device as a titanium ring held firmly to the cranium by four titanium pins, attached by carbon fiber rods to a polythene vest, which immobilizes the cervical spine (Glover et al., 2013, checked 2026-10-30). The same report states that, unlike hard collars, it leaves the mandible free, and that it has been in use in its current form since 1959.
The terms “halo vest”, “halo brace” and “halo” are used for the same ring-and-vest arrangement. “Halo traction” is a different phrase: the FDA regulation that covers halo rings is titled “Skull tongs for traction”, so traction hardware and halo rings sit in one regulatory category. This page does not cover traction technique.
How it is used in practice
Glover et al. state that the halo is frequently used in the treatment of unstable cervical spine fractures. FDA’s regulation describes the wider device type as “an instrument used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation)” (21 CFR 882.5960, eCFR, checked 2026-10-30). Fitting, pin care and removal are clinical procedures and are outside the scope of this page.
What a halo system is made of
The main parts of a halo system, as described in the Glover et al. case report, are listed below.
| Part | Description |
|---|---|
| Ring | Titanium; held firmly to the cranium |
| Pins | Four titanium pins fix the ring to the skull |
| Rods | Carbon fiber rods connect the ring to the vest |
| Vest | Polythene vest worn on the trunk |
| Mandible | Left free, unlike with hard collars |
Halo vest compared with a cervical collar
The one difference the case report states is that, unlike hard collars, the halo leaves the mandible free. For a plain-language explanation of the collar side, see What Is a Cervical Collar?. For the screening rules clinicians use before deciding on spinal imaging, see NEXUS criteria and the Canadian C-Spine Rule.
Where it matters for labs, clinics and supply decisions
A catalogue entry for a halo ring, pin set or vest component can be checked against public regulatory records. These are the fields that FDA’s own records give for halo rings (openFDA device classification and the FDA 510(k) database, checked 2026-10-30):
- Regulation number: 882.5960, “Skull tongs for traction”, under the neurological devices part of the CFR.
- Product code: HAX, device name “Tong, Skull For Traction”, review panel and specialty Neurology.
- Device class: Class II (performance standards), listed as class 2 in openFDA.
- Premarket route: a 510(k) record shows a decision date and the regulation and product code. For example, K051918 (RESOLVE Open Back Halo Rings, Jerome Medical) was found substantially equivalent on 08/17/2005 under 882.5960 and code HAX. A 510(k) is a premarket notification; see FDA 510(k) premarket notification.
The record for a halo ring does not by itself classify a whole vest assembly. A ring cleared under HAX tells you how that component is classified, and the clearance record for each component you are comparing should be read for its own indications. Post-market reporting duties for devices in general are explained in medical device reporting (MDR), and the statutory background in Medical Device Amendments of 1976.
Known complications reported in the literature
Glover et al. list common complications as pin loosening, pin site infection, pressure sores, respiratory tract infections, cosmetic scarring and pin site discomfort, and describe intracranial penetration as rare. They identify immunosuppression (for example diabetes or splenectomy) and low bone density or osteoporosis as higher-risk groups. The report does not give incidence figures, so none are quoted here.
Common misunderstandings
- “A halo vest is a collar.” It is not. It is anchored to the skull by pins and leaves the mandible free, in contrast to hard collars.
- “Halo vest and halo traction are the same thing.” They are related but not identical. The FDA regulation covering halo rings is titled for traction, while the vest is the trunk component that the ring is rodded to.
- “The vest has its own FDA classification.” The record cited here is for halo rings under HAX and 882.5960. Do not assume a separate classification for the vest from it.
FAQ
Is a halo vest the same as halo traction?
No. A halo vest is the ring, pins, rods and vest system that immobilizes the cervical spine. “Traction” appears in the title of the FDA regulation (21 CFR 882.5960, “Skull tongs for traction”) that covers halo rings, but this page does not describe traction technique.
What is a halo vest made of?
A titanium ring, four titanium pins, carbon fiber rods and a polythene vest, according to Glover et al. (2013).
How is a halo ring regulated by FDA?
As a Class II device under 21 CFR 882.5960, product code HAX. Example clearance: 510(k) K051918, decided 08/17/2005.
Sources
All sources below were checked on 2026-10-30.
- 21 CFR 882.5960, Skull tongs for traction, eCFR: https://www.ecfr.gov/current/title-21/section-882.5960
- FDA product classification, product code HAX, openFDA device classification: https://open.fda.gov/apis/device/classification/
- FDA 510(k) database, K051918: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051918
- Glover et al., Int J Spine Surg 2013;7:e42-e44: https://pmc.ncbi.nlm.nih.gov/articles/PMC4300969
