# K192768: Temporary Fixation Pins

- Pathway: 510(k) (Traditional)
- Applicant: Eisertech, LLC
- Decided: Dec 26, 2019 after 87 days
- Product code: JDW (Pin, Fixation, Threaded)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K961522 (1996). 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)
- K131459: Aap K-Wire, Steinmann Pin, Cerclage Wire, Aap Implantate AG (2013) Summary page 4.

## Most influential descendants
- K231905: Electro-Spec Steri-Caps (2023), 0 descendants of its own

## Indications for use
Eisertech, LLC Temporary Fixation Pins are indicated for the following: - guide wire for osteosynthesis implants - accessories for external fixation (Steinmann Pin) - application as implant according to the principles of fracture management

Source page: https://510kreport.com/device/K192768
Methodology: https://510kreport.com/methodology