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This page describes a device class and general product information from named sources. It is not medical advice and contains no application instructions.
Short answer
Gardner-Wells tongs are a type of skull tongs for traction: a caliper-shaped device whose skin-penetrating tips anchor to the skull so an attached weight can hold the head and neck in position. FDA regulates the whole device type as “Skull tongs for traction” (21 CFR 882.5960), Class II, product code HAX. Crutchfield tongs are another skeletal traction caliper; “skull tongs” is the regulatory umbrella.
Definition and scope
FDA’s identification text in 21 CFR 882.5960 (checked 2026-10-30) describes skull tongs for traction as an instrument used to immobilize a patient with a cervical spine injury. It is caliper-shaped, has skin-penetrating tips that are anchored to the skull, and uses an attached weight to hold position through traction. The same section classifies the device as Class II (performance standards).
The openFDA classification record for product code HAX (checked 2026-10-30) names the device “Tong, Skull For Traction”, device class 2, regulation number 882.5960, specialty Neurology, not an implant. Third-party review is flagged as eligible for the code. Because the code is shared across the device type, it also holds records for halo rings (the Jerome Medical “Resolve Open Back Halo Rings” 510(k), K051918, decided 2005-08-17, is an example). That is why the halo vest guide cites the same regulation.
How Gardner-Wells tongs are described in the literature
A 2018 systematic review in the Journal of Spine Surgery (Saleh and colleagues, PMC5911751, checked 2026-10-30) credits the design to Dr. James Gardner, introduced in 1973. It describes the device as a rigid bar that follows the coronal contour of the skull, with a hole at each end that accommodates a screw into the outer table of the skull. The screws are tilted in the direction of the pull, which the review says minimizes screw pullout. A retractable spring at one end is calibrated to display force in pounds.
The review lists the advantages reported for the device as ease of use, sterile technique, no skin incisions and no drill holes. For a general overview of cervical traction equipment and how it is regulated and covered, see cervical traction devices: types, FDA class and Medicare coverage.
Gardner-Wells, Crutchfield and other skull tongs
Catalogues, clinical papers and the FDA use different names for overlapping things. The table lists only what the sources above state.
| Name | What the sources say | Source |
|---|---|---|
| Skull tongs for traction | The FDA device type: caliper-shaped, skin-penetrating tips anchored to the skull, weight-based traction; Class II; product code HAX | 21 CFR 882.5960; openFDA |
| Gardner-Wells tongs | Introduced 1973; rigid bar following the skull contour; screws angled with the pull; spring gauge reading in pounds | Saleh et al. 2018 |
| Crutchfield caliper (Crutchfield tongs) | Named in the review as one of several skeletal traction apparatuses used besides Gardner-Wells tongs, alongside Cone’s and Blackburn’s calipers and halo traction | Saleh et al. 2018 |
| Halo traction | Listed in the same review as a separate skeletal traction option; halo rings share product code HAX | Saleh et al. 2018; openFDA |
Specification points that the research reports
The review is a clinical source, not a purchasing guide, but it reports device test figures that explain why specifications matter. These are research findings, not recommendations for use.
- Force display: the spring is calibrated in pounds, so the unit on the gauge is part of the device’s definition.
- Cadaver perforation: one study reported an average of 162 lb to perforate the inner table of the skull with a properly placed pin.
- Material and MRI: a comparison of titanium-alloy MRI-compatible tongs with stainless-steel MRI-incompatible tongs reported an average of 225 lb to pull out a stainless-steel pin, and pull-out with MRI-compatible tongs at a mean of 75 lb.
Where it matters for labs, clinics and supply decisions
The sources support a short set of questions to put to a product listing or instructions for use, framed as questions rather than advice:
- Is the product described as skull tongs for traction under 21 CFR 882.5960, and which product code does the listing cite?
- Does the labeling state MRI compatibility, given the reported difference between titanium-alloy and stainless-steel designs?
- In which units does the force gauge read?
- Does the labeling, rather than a catalogue name alone, say which design it is (Gardner-Wells style or another caliper)?
Common misunderstandings
“Skull tongs” and “Gardner-Wells tongs” are not interchangeable terms
Skull tongs for traction is the FDA device type; Gardner-Wells is one named design within the literature. Crutchfield is a different caliper named in the same review.
Skull tongs are not the same as a skull clamp
Skull clamps used to hold the head during surgery are classified separately; see neurosurgical instruments.
A published force figure is not a rating
The 162, 225 and 75 lb values are results of specific studies, not specifications of any product.
FAQ
What are Gardner-Wells tongs?
A skull tong design introduced in 1973 that anchors to the skull with angled screws and has a spring gauge reading in pounds, used for skeletal traction (Saleh et al., 2018).
Are Gardner-Wells tongs regulated by FDA?
Skull tongs for traction are Yes. Skull tongs for traction are Class II (performance standards) under 21 CFR 882.5960, product code HAX.
What are Crutchfield tongs?
Crutchfield’s caliper is named in the 2018 review as another skeletal traction apparatus used besides Gardner-Wells tongs. The review gives no further design detail.
Do Gardner-Wells tongs need MRI-compatible materials?
The review describes a comparison of titanium-alloy MRI-compatible tongs with stainless-steel MRI-incompatible tongs. Whether a given product is MRI compatible is stated in its labeling.
What does “skull tongs” mean?
It is FDA’s name for a caliper-shaped device with skin-penetrating tips that anchors to the skull so a weight can hold position in traction.
Sources
- 21 CFR 882.5960, Skull tongs for traction, eCFR, checked 2026-10-30.
- openFDA device classification, product code HAX, checked 2026-10-30.
- Saleh H, Yohe N, Razi A, Saleh A. Efficacy and complications of the use of Gardner-Wells tongs: a systematic review. J Spine Surg 2018;4(1):123-129. PMC5911751, checked 2026-10-30.
