510(k) · Decided
Recalled · 2009Ngarde System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
N Spine, Inc. · NQP Posterior Metal/Polymer Spinal System, Fusion
Cleared on Oct 19, 2007 as substantially equivalent to K061774 (N Spine, Inc., 2006) and 2 other predicates after a 28-day review. Its family tree reaches back 7 generations to 1990. It has been recalled 9 times.
- Decided
- Oct 19, 2007
- Review
- 28 days
- Class
- Class II
- Product code
- NQP
- Recalls
- 9
- Predicates
- 3
Its longest line of descent runs back 7 generations to K901587 (1990). 55 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 6 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 5 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 4 generations backK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
- 3 generations backK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
- 2 generations backK020245 Modification to Isobar Spinal SystemScien'Tx USA, Inc. · 2002
- 1 generation backK061774 Nfix II Pedicle Screw SystemN Spine, Inc. · 2006 · Recalled
- This deviceK072685 Ngarde SystemN Spine, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −6 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −5 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −4 | K980484 | Aesculap Spine System Evolution | Aesculap, Inc. | 1998 | — |
| −3 | K990118 | Isobar Spinal System | Scien'Tx USA, Inc. | 1999 | — |
| −2 | K020245 | Modification to Isobar Spinal System | Scien'Tx USA, Inc. | 2002 | — |
| −1 | K061774 | Nfix II Pedicle Screw System | N Spine, Inc. | 2006 | 7 |
| 0 (this device) | K072685 | Ngarde System | N Spine, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 7 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NQP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NQP device
- #1 K203678 CD HORIZON™ Spinal Systemscore 10.9 · 15 generations · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061774 | Nfix II Pedicle Screw SystemSummary page 1…Orthopaedic and Rehabilitation Devices Panel Product Code NQP Predicate Device: NFix II Pedicle Screw System (N Spine, Inc. K061774) Pangea Pedicle Screw System (Synthes, Inc. K052123) Click'X Pedicle Screw Sy… | 2006 |
| * | K052123 | Synthes Pangea SystemSummary page 1…Product Code NQP Predicate Device: NFix II Pedicle Screw System (N Spine, Inc. K061774) Pangea Pedicle Screw System (Synthes, Inc. K052123) Click'X Pedicle Screw System (Synthes, Inc. K992739) Device Description: The NGarde System is a… | 2005 |
| * | K992739 | Click'xSummary page 1…Spine, Inc. K061774) Pangea Pedicle Screw System (Synthes, Inc. K052123) Click'X Pedicle Screw System (Synthes, Inc. K992739) Device Description: The NGarde System is a posterior, non-cervical instrumentation system consi… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 9, 2009 | Not classified | Z-2346-2010 | Equipment maintenance | package integrity compromised |
| Feb 9, 2009 | Not classified | Z-2347-2010 | Equipment maintenance | package integrity compromised |
| Feb 9, 2009 | Not classified | Z-2348-2010 | Equipment maintenance | package integrity compromised |
| Feb 9, 2009 | Not classified | Z-2345-2010 | Equipment maintenance | package integrity compromised |
| Feb 9, 2009 | Not classified | Z-2344-2010 | Equipment maintenance | package integrity compromised |
| Nov 7, 2008 | Not classified | Z-0968-2009 | Nonconforming Material/Component | the dimensional specifications are incorrect |
| Nov 7, 2008 | Not classified | Z-0966-2009 | Nonconforming Material/Component | the dimensional specifications are incorrect |
| Nov 7, 2008 | Not classified | Z-0965-2009 | Nonconforming Material/Component | the dimensional specifications are incorrect |
| Nov 7, 2008 | Not classified | Z-0967-2009 | Nonconforming Material/Component | the dimensional specifications are incorrect |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 55 ancestors have a recall of any class.
- 1 other device also cites its predicate K061774.
How does its category compare?
All NQP devicesNQP Posterior Metal/Polymer Spinal System, Fusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NQP
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · NQP
70in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQP
6in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQP
8in 2025
MAUDE reports naming product code NQP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 34 | 45 |
| 2008 | 6 | 156 | 4 | 101 |
| 2009 | 3 | 70 | 6 | 109 |
| 2010 | 2 | — | 0 | 119 |
| 2011 | 0 | — | 0 | 60 |
| 2012 | 0 | — | 6 | 66 |
| 2013 | 0 | — | 0 | 58 |
| 2014 | 1 | — | 0 | 46 |
| 2015 | 0 | — | 0 | 38 |
| 2016 | 0 | — | 0 | 79 |
| 2017 | 0 | — | 0 | 28 |
| 2018 | 0 | — | 0 | 29 |
| 2019 | 2 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (114 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072685 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072685: Ngarde System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072685
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026