# K163303: OsteoMed ExtremiFix Mid and Large Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed, LLC
- Decided: Apr 4, 2017 after 133 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 6 generations back to K962823 (1996). 23 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063298: Osteomed Headless Cannulated Screw System, Osteomed LP (2007) Summary page 4.
- K151021: OsteoMed Cannulated Screw System, Osteomed Corp. (2015) Summary page 4.
- K963172: Synthes Sterile 4.5 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 4.
- K951389: Reunion Bone Screw System, Smith & Nephew Richards, Inc. (1995) Summary page 4.
- K954330: Super Screw 3.5 MM, Osteomed Corp. (1995) Summary page 4.

## Most influential descendants
- K230744: Acumed Acutrak 3 Headless Compression Screw System (2023), 1 descendant of its own
- K250251: Eleganz Fusion Screw System (Fusion Screw System) (2025), 0 descendants of its own
- K221333: Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional (2022), 0 descendants of its own

## Indications for use
The OsteoMed ExtremiFix Mid & Large Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, and fracture fixation of foot, ankle, and long bones (upper and lower extremity). The screws are intended for single use only. The system drills and guide wires are single use instruments.

Source page: https://510kreport.com/device/K163303
Methodology: https://510kreport.com/methodology