# K063298: Osteomed Headless Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Mar 2, 2007 after 121 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: 5 generations back to K962823 (1996). 14 ancestors in all.
246 later devices descend from it; 13 cite it directly.
1 of 261 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060071: Nexa Compression Screw, Nexa Orthopedics, Inc. (2006) Summary page 1.
- K043102: Multi-Use Compression Screw, Wrightmedicaltechnologyinc (2005) Summary page 1.
- K792022: Herbert Bone Screw, Zimmer, Inc. (1979) Summary page 1.
- K014154: Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone Screws DB1 Thread,Model F20-XX-00, Vilex, Inc. (2002) Summary page 1.
- K954330: Super Screw 3.5 MM, Osteomed Corp. (1995) Summary page 1.

## Most influential descendants
- K111994: Smith & Nephew Cannulated Screws and Washers (2011), 161 descendants of its own
- K143039: CrossRoads Screw System (2015), 79 descendants of its own
- K162825: CAPTIVATE™ Compression Screws (2017), 74 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own
- K083912: Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins (2009), 48 descendants of its own

## Indications for use
The Osteomed Headless Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

Source page: https://510kreport.com/device/K063298
Methodology: https://510kreport.com/methodology