# K031127: Orthopedic Wire

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Apr 28, 2003 after 19 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (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; 2 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. The FDA summary names its predicate without a number.
- (no number) Orthopedic Wire: named in the summary without a submission number

## Most influential descendants
- K110895: Ortho Solutions Trauma Implants for Osteosynthesis (2011), 8 descendants of its own
- K163489: OrthoSolutions 'System26' Bone Screws (2017), 3 descendants of its own
- K150889: Suture Wires and Wire Loops (2015), 2 descendants of its own
- K203773: BRM TOOL Screws (2022), 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

## Recalls of this device
- Dec 23, 2015 · Class II · Z-0855-2016: The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instructions For Use (IFU) states the device are sterilized via gamma irradiation and should not be resterilize

## Indications for use
The subject orthopedic wires are single-use devices. They are intended for: Bone fracture fixation, Osteotomy, Arthrodesis, Correction of deformity, Revision procedures where other treatments or devices have been unsuccessful, and; Bone reconstruction procedures.

Source page: https://510kreport.com/device/K031127
Methodology: https://510kreport.com/methodology