# K071035: Ifs Bone Fixation Devices

- Pathway: 510(k) (Traditional)
- Applicant: Internal Fixation Systems, Inc.
- Decided: Aug 13, 2007 after 123 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 K761228 (1976). 40 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 44 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.
- K011719: Plus Cancellous Bone Screws, Plus Orthopedics (2001). Our reading of the summary gave K001719, FDA’s number for Q-Lux Plasma 100 Light Cure Unit (Rolence Enterprise Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Plus Cancellous Bone Screws”.
- K972403: Bti Cortical Bone Screws, Biodynamic Technologies, Inc. (1997) Summary page 1.
- K063589: Gso Bone Fixation Fasteners, Gold Standard Orthopaedics, LLC (2007) Summary page 1.
- K053394: Nexa Bone Screw System, Nexa Orthopedics, Inc. (2005) Summary page 1.
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 1.
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K023260: 1.2MM Osteomed Auto-Drive Screw System, Osteomed Corp. (2002) Summary page 1.

## Most influential descendants
- K130613: Cannulated Screw and Kirschner (Kwire) System (2014), 1 descendant of its own
- K252758: Cannulated Screw and Kirschner (K wire) System (2025), 0 descendants of its own
- K140216: Orthopedic Fixation Systems (2014), 0 descendants of its own

## Indications for use
The IFS Bone Fixation Devices 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. ***Warning: IFS Bone Fixation Devices are not indicated for spinal fixation,***

Source page: https://510kreport.com/device/K071035
Methodology: https://510kreport.com/methodology