# K983121: Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220

- Pathway: 510(k) (Traditional)
- Applicant: Syntec Scientific Corp.
- Decided: Oct 5, 1998 after 27 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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
No predicates in its family tree.
127 later devices descend from it; 7 cite it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K022599: Newdeal K Wire (2002), 118 descendants of its own
- K101165: Pro-Toe VO Hammertow Implant System (2010), 80 descendants of its own
- K070598: Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse (2007), 72 descendants of its own
- K120645: Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition (2012), 61 descendants of its own
- K120165: Intraosseous Fixation System (2012), 35 descendants of its own

## Indications for use
The Kirschner Wires and Steinmann Pins are provided non-sterile. The devices are indicated for use in fracture fixation, for healing of facile bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.

Source page: https://510kreport.com/device/K983121
Methodology: https://510kreport.com/methodology