# K053045: Modification to:  Mayfield Radiolucent Skull Pins, Model 4-0-a-2020

- Pathway: 510(k) (Special)
- Applicant: Integra LifeSciences Corporation
- Decided: Nov 21, 2005 after 24 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
Longest line of descent: 2 generations back to K923789 (1993). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021604: Mayfield Radiolucent Skull Pins, Model 4-0-a-2020, Ohio Medical Instrument Co., Inc. (2002) Summary page 1.

## Most influential descendants
- K071458: Mayfield Radiolucent Disposable Skull Pins (2007), 5 descendants of its own
- K072208: Mayfield Disposable and Reusable Titanium Skull Pins (2007), 4 descendants of its own
- K103493: Head Fiation Device (HFD 100) (2011), 2 descendants of its own
- K250423: mb-FIX Cranial Stabilization Systems (2025), 0 descendants of its own
- K141950: HFD100 Rocker Arm Accessory (2014), 0 descendants of its own

## Indications for use
The MAYFIELD® Radiolucent Skull Pins A-2020 are intended for use with a skull clamp that is placed on the patient's skull to hold their head and neck in a particular position during surgical procedures when rigid skeletal fixation is desired and Intra-Operative CT or MR imaging is used. The MAYFIELD® Radiolucent Skull Pins A-2020 are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and when Intra-Operative CT or MR imaging of the patient is used.

Source page: https://510kreport.com/device/K053045
Methodology: https://510kreport.com/methodology