# K073163: Limited Artifact Skull Pin, Model 0107

- Pathway: 510(k) (Traditional)
- Applicant: Dinkler Surgical Devices, Inc.
- Decided: Feb 28, 2008 after 111 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: 1 generation back to K923789 (1993). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923789: Mayfield Adult Disposable Skull Pin, Ohio Medical Instrument Co., Inc. (1993) Summary page 1.

## Most influential descendants
- K193438: DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) (2020), 1 descendant of its own
- K241883: DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs)  (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs)  (3006-50) (2024), 0 descendants of its own

## Indications for use
The Limited Artifact Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is required and during intra-operative use within a MR environment rated up to and including a 1.5 Tesla magnetic field. The Limited Artifact Skull Pins are used in open and percutaneous craniotomies such as biopsies, thalamotomies and electrode implants; and in spinal surgeries when rigid skeletal fixation is necessary. The pins are also indicated for use during intra-operative use within a MR environment rated up to and including a 1.5 Tesla magnetic field. The target population for the limited artifact skull pins is that part of the population that requires the use of a head holder to fixate their head and neck in a particular position during surgical procedures.

Source page: https://510kreport.com/device/K073163
Methodology: https://510kreport.com/methodology