# K193438: DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)

- Pathway: 510(k) (Traditional)
- Applicant: Pro Med Instruments GmbH
- Decided: Jun 2, 2020 after 174 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). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163322: TZ SKULL PIN Adult, Tz Medical, Inc. (2017) Summary page 5.
- K941558: Mayfield Child Disposable Skull Pin, Ohio Medical Instrument Co., Inc. (1995) Summary page 5.
- K073163: Limited Artifact Skull Pin, Model 0107, Dinkler Surgical Devices, Inc. (2008) Summary page 6.

## Most influential descendants
- 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
Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.

Source page: https://510kreport.com/device/K193438
Methodology: https://510kreport.com/methodology