# K072685: Ngarde System

- Pathway: 510(k) (Special)
- Applicant: N Spine, Inc.
- Decided: Oct 19, 2007 after 28 days
- Product code: NQP (Posterior Metal/Polymer Spinal System, Fusion)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K901587 (1990). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061774: Nfix II Pedicle Screw System, N Spine, Inc. (2006) Summary page 1.
- K052123: Synthes Pangea System, Synthes (Usa) (2005) Summary page 1.
- K992739: Click'x, Synthes Spine (2000) Summary page 1.

## 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-0968-2009: the dimensional specifications are incorrect
- Nov 7, 2008 · Not classified · Z-0966-2009: the dimensional specifications are incorrect
- Nov 7, 2008 · Not classified · Z-0965-2009: the dimensional specifications are incorrect
- Nov 7, 2008 · Not classified · Z-0967-2009: the dimensional specifications are incorrect

## Indications for use
When used as a pedicle screw fixation system in skeletally mature patients, the NGarde 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 lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, and kyphosis. In addition, when used as a pedicle screw fixation system, the NGarde 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/K072685
Methodology: https://510kreport.com/methodology