510(k) · Decided
Recalled · 2009Nfix II Pedicle Screw 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 Dec 13, 2006 as substantially equivalent to K990118 (Scien'Tx USA, Inc., 1999) and 8 other predicates after a 173-day review. Its family tree reaches back 6 generations to 1990. 2 later devices descend from it. It has been recalled 7 times.
- Decided
- Dec 13, 2006
- Review
- 173 days
- Class
- Class II
- Product code
- NQP
- Recalls
- 7
- Predicates
- 9
Its longest line of descent runs back 6 generations to K901587 (1990). 51 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 5 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 4 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 3 generations backK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
- 2 generations backK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
- 1 generation backK020245 Modification to Isobar Spinal SystemScien'Tx USA, Inc. · 2002
- This deviceK061774 Nfix II Pedicle Screw SystemN Spine, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK073143 Modified Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK072685 Ngarde SystemN Spine, Inc. · 2007 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −5 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −4 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −3 | K980484 | Aesculap Spine System Evolution | Aesculap, Inc. | 1998 | — |
| −2 | K990118 | Isobar Spinal System | Scien'Tx USA, Inc. | 1999 | — |
| −1 | K020245 | Modification to Isobar Spinal System | Scien'Tx USA, Inc. | 2002 | — |
| 0 (this device) | K061774 | Nfix II Pedicle Screw System | N Spine, Inc. | 2006 | — |
| +1 | K073143 | Modified Vertiflex Spinal Screw System | Vertiflex, Inc. | 2008 | — |
| +1 | K072685 | Ngarde System | N Spine, Inc. | 2007 | 9 |
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 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 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? (9)
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 |
|---|---|---|---|
| * | K990118 | Isobar Spinal SystemSummary page 1…CFR, §888.3070 5.3 Predicate Devices The subject device is substantially equivalent to the following predicate devices: * Isobar System (Scient'x USA; K990118 to K020245) * Moss Miami System (DePuy Acromed; K950697 to K030383) • Synergy System (Interpore Cross; K950099 to… | 1999 |
| * | K020245 | Modification to Isobar Spinal SystemSummary page 1…3070 5.3 Predicate Devices The subject device is substantially equivalent to the following predicate devices: * Isobar System (Scient'x USA; K990118 to K020245) * Moss Miami System (DePuy Acromed; K950697 to K030383) • Synergy System (Interpore Cross; K950099 to KO01437)… | 2002 |
| * | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle FixationSummary page 1…ce is substantially equivalent to the following predicate devices: * Isobar System (Scient'x USA; K990118 to K020245) * Moss Miami System (DePuy Acromed; K950697 to K030383) • Synergy System (Interpore Cross; K950099 to KO01437) * Optima System (U & I Corp.; K024096) *… | 1995 |
| * | K030383 | Modification to Moss Miami Spinal System Polyaxial ScrewsSummary page 1…antially equivalent to the following predicate devices: * Isobar System (Scient'x USA; K990118 to K020245) * Moss Miami System (DePuy Acromed; K950697 to K030383) • Synergy System (Interpore Cross; K950099 to KO01437) * Optima System (U & I Corp.; K024096) * NFix Sys… | 2003 |
| * | K950099 | Synergy (TM) TI Posterior Spinal SystemSummary page 1…es: * Isobar System (Scient'x USA; K990118 to K020245) * Moss Miami System (DePuy Acromed; K950697 to K030383) • Synergy System (Interpore Cross; K950099 to KO01437) * Optima System (U & I Corp.; K024096) * NFix System (N Spine; K053623) * DYNESYS® System (Ce… | 1997 |
| * | K001437 | Ensite 3000 System, Model EE3000 | 2000 |
| * | K024096 | Optima, Spinal SystemSummary page 1…245) * Moss Miami System (DePuy Acromed; K950697 to K030383) • Synergy System (Interpore Cross; K950099 to KO01437) * Optima System (U & I Corp.; K024096) * NFix System (N Spine; K053623) * DYNESYS® System (Centerpulse Spine-Tech; K031511) 5.4 Device Description… | 2003 |
| * | K053623 | Nfix Fusion System Cleared while this submission was under review Summary page 1…cromed; K950697 to K030383) • Synergy System (Interpore Cross; K950099 to KO01437) * Optima System (U & I Corp.; K024096) * NFix System (N Spine; K053623) * DYNESYS® System (Centerpulse Spine-Tech; K031511) 5.4 Device Description The subject NFix II device is a pos… | 2006 |
| * | K031511 | Dynesys Spinal SystemSummary page 1…ore Cross; K950099 to KO01437) * Optima System (U & I Corp.; K024096) * NFix System (N Spine; K053623) * DYNESYS® System (Centerpulse Spine-Tech; K031511) 5.4 Device Description The subject NFix II device is a posterior instrumentation system consisting of both pedic… | 2004 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-0963-2009 | Nonconforming Material/Component | the dimensional specifications are incorrect |
| Nov 7, 2008 | Not classified | Z-0964-2009 | Nonconforming Material/Component | the dimensional specifications are incorrect |
The 5 latest of 7 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 16 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 51 ancestors have a recall of any class.
- Of its descendants, K073143 (Vertiflex, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K990118.
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.
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 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).…
Read the full statement (123 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061774 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061774: Nfix II Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061774
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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