# K102528: N-Force Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Innovision, Inc.
- Decided: Jul 28, 2011 after 328 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: 10 generations back to K960978 (1996). 77 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083912: Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins, Treu-Instrumente GmbH (2009) Summary page 1.
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories), Smith & Nephew, Inc. (1999) Summary page 1.
- K961213: Alta Dome and Plunger (Mec Hip Bolt), Howmedica Corp. (1996) Summary page 1.
- K991889: Ultimax Haig II Nail System, Encore Orthopedics, Inc. (1999) Summary page 1.
- K101557: Gamma-BSM, Beta-BSM, Equivabone, Carigen, Etex Corp. (2010) Summary page 2.

## Most influential descendants
- K132244: N-Force Fixation System (2014), 3 descendants of its own
- K151146: N-Force Fixation System (2015), 1 descendant of its own
- K142776: Flow-Screw (2015), 1 descendant of its own
- K173556: Injection Screw (2018), 0 descendants of its own
- K160791: AmorChem Titanium Porous Fixation Device (2016), 0 descendants of its own

## Indications for use
The N-Force Fixation System is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the N-Force Fixation System can also be used to deliver the following bone void fillers to a surgical site: Beta-bsm (ETEX Corporation) CarriGen (ETEX Corporation)

Source page: https://510kreport.com/device/K102528
Methodology: https://510kreport.com/methodology