# K061774: Nfix II Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: N Spine, Inc.
- Decided: Dec 13, 2006 after 173 days
- Product code: NQP (Posterior Metal/Polymer Spinal System, Fusion)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K901587 (1990). 51 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990118: Isobar Spinal System, Scien'Tx USA, Inc. (1999) Summary page 1.
- K020245: Modification to Isobar Spinal System, Scien'Tx USA, Inc. (2002) Summary page 1.
- K950697: Depuy Motech Moss Miami Spinal System - Pedicle Fixation, Depuy Motech (1995) Summary page 1.
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws, Depuyacromed (2003) Summary page 1.
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 1.
- K001437: Ensite 3000 System, Model EE3000, Endocardial Solutions, Inc. (2000)
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 1.
- K053623: Nfix Fusion System, N-Spine, Inc. (2006). Cleared while this submission was under review Summary page 1.
- K031511: Dynesys Spinal System, Centerpulse Spine-Tech, Inc. (2004) Summary page 1.

## Most influential descendants
- K073143: Modified Vertiflex Spinal Screw System (2008), 0 descendants of its own
- K072685: Ngarde System (2007), 0 descendants of its own

## Recalls of this device
- Feb 9, 2009 · Not classified · Z-2346-2010: package integrity compromised
- Feb 9, 2009 · Not classified · Z-2347-2010: package integrity compromised
- Feb 9, 2009 · Not classified · Z-2348-2010: package integrity compromised
- Feb 9, 2009 · Not classified · Z-2345-2010: package integrity compromised
- Feb 9, 2009 · Not classified · Z-2344-2010: package integrity compromised
- Nov 7, 2008 · Not classified · Z-0963-2009: the dimensional specifications are incorrect
- Nov 7, 2008 · Not classified · Z-0964-2009: the dimensional specifications are incorrect

## Indications for use
When used as a pedicle screw fixation system in skeletally mature patients, the N Fix II System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis). In addition, when used as a pedicle screw fixation system, the N Fix II System is indicated in patients: * who are receiving fusions with autogenous graft only; * who are having the device fixed or attached to the lumbar or sacral spine, * who are having the device removed after the development of a solid fusion mass.

Source page: https://510kreport.com/device/K061774
Methodology: https://510kreport.com/methodology