# K163322: TZ SKULL PIN Adult

- Pathway: 510(k) (Traditional)
- Applicant: Tz Medical, Inc.
- Decided: Feb 23, 2017 after 90 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). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 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 4.
- K932860: Mayfield Adult Disposable Skull Pin, Ohio Medical Instrument Co., Inc. (1993) Summary page 4.

## 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 TZ Medical skull pin is placed in a clamp and is applied to the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.

Source page: https://510kreport.com/device/K163322
Methodology: https://510kreport.com/methodology