# K831005: Wire & Steinman Pins

- Pathway: 510(k) (Traditional)
- Applicant: Kirschner Medical Corp.
- Decided: May 18, 1983 after 49 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K143618: Kirschner Wires, Steinmann Pins (2015), 7 descendants of its own
- K241014: Biomet Kirschner Wires (K-Wires) (2024), 2 descendants of its own
- K253718: enHAnce PEEK Bunion System (2026), 1 descendant of its own
- K151848: Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System (2016), 1 descendant of its own
- K262098: EnHAnce PEEK Bunion System (2026), 0 descendants of its own

## Recalls of this device
- May 16, 2018 · Class II · Z-2242-2018: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires pac
- May 16, 2018 · Class II · Z-2241-2018: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires pac
- May 16, 2018 · Class II · Z-2240-2018: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires pac
- May 16, 2018 · Class II · Z-2238-2018: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires pac
- May 16, 2018 · Class II · Z-2234-2018: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires pac
- May 16, 2018 · Class II · Z-2235-2018: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires pac
- May 16, 2018 · Class II · Z-2236-2018: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires pac
- May 16, 2018 · Class II · Z-2239-2018: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires pac
- May 16, 2018 · Class II · Z-2237-2018: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires pac
- May 16, 2018 · Class II · Z-2230-2018: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires pac
- May 16, 2018 · Class II · Z-2233-2018: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires pac
- May 16, 2018 · Class II · Z-2231-2018: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires pac
- May 16, 2018 · Class II · Z-2232-2018: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires pac
- Aug 2, 2016 · Class II · Z-0087-2017: The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and one (1) 467255-02 Plain Tip Guide Pin. The G-PIN 2.8BL 3.2PL 60 CM 2PK may have been packaged incorrectl
- Apr 1, 2016 · Class II · Z-1822-2016: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non

Source page: https://510kreport.com/device/K831005
Methodology: https://510kreport.com/methodology