# K051440: Mayfield Infinity Skull Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Integra Lifesciences Corp.
- Decided: Sep 20, 2005 after 110 days
- Product code: HBL (Holder, Head, Neurosurgical (Skull Clamp))
- Device class: 2
- Regulation: 21 CFR 882.4460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Modified Mayfield® Skull Clamp: named in the summary without a submission number
- (no number) Mayfield A2000 Skull Clamp: named in the summary without a submission number
- (no number) DORO® Skull Clamp: named in the summary without a submission number

## Most influential descendants
- K090506: Mayfield Infinity XR2 Skull Clamp, Model a-2114 (2009), 5 descendants of its own
- K120633: Mayfield Skull Clamp (2012), 2 descendants of its own
- K142238: MAYFIELD Skull Clamp (2014), 1 descendant of its own
- K130389: Mayfield Infinity XR2 Skull Clamp (2013), 1 descendant of its own
- K250423: mb-FIX Cranial Stabilization Systems (2025), 0 descendants of its own

## Indications for use
The Mayfield® Infinity Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The skull clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. The accessories provided with the skull clamp also allow it to be used where stabilization is desired instead of complete fixation.

Source page: https://510kreport.com/device/K051440
Methodology: https://510kreport.com/methodology