# K070555: Orthopro Steinman Pins and Kirschner Wires

- Pathway: 510(k) (Traditional)
- Applicant: Orthopro, LLC
- Decided: Jul 13, 2007 after 136 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
Longest line of descent: 1 generation back to K960385 (1996). 2 ancestors in all.
37 later devices descend from it; 4 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960385: Sterile Kirschner Wires and Steinmann Pins, Depuy, Inc. (1996) Summary page 1.
- K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories], Smith & Nephew, Inc. (2000) Summary page 1.
- (no number) Smith and Nephew Pins and Wires: named in the summary without a submission number

## Most influential descendants
- K113006: I-Fuse Hammer Toe Systems (2012), 27 descendants of its own
- K141857: CrossTie Intraosseous Fixation System (2015), 16 descendants of its own
- K151270: CrossTIE Intraosseous Fixation System (2015), 15 descendants of its own
- K181872: MIS Bunion System (2019), 14 descendants of its own
- K142585: PhaLinx Hammertoe System (2014), 9 descendants of its own

## Indications for use
The OrthoPro Steinman Pins and Kirschner Wires are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

Source page: https://510kreport.com/device/K070555
Methodology: https://510kreport.com/methodology