510(k) Report

510(k) · Cleared

Cleared

Nfix Fusion System

K053623510(k) TraditionalCleared Jul 12, 2006196-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

N-Spine, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Jul 12, 2006 after a 196-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.

Decided
Jul 12, 2006
Review
196 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
0

5 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2008: 2 descendants cleared2007: 1 descendant cleared2009: 1 descendant cleared20052010201520202025
  1. This deviceK053623 Nfix Fusion SystemN-Spine, Inc. · 2006
  2. Descendant · cites it directly · 2 of its ownK061774 Nfix II Pedicle Screw SystemN Spine, Inc. · 2006 · Recalled
  3. Descendant · cites it directly · 1 of its ownK080876 DVX Spine SystemBk Meditech, Co., Ltd. · 2008
  4. Descendant · 2 generations on · 0 of its ownK090424 DVX Spine SystemBk Meditech, Co., Ltd. · 2009
  5. Descendant · 2 generations on · 0 of its ownK073143 Modified Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008
  6. Descendant · 2 generations on · 0 of its ownK072685 Ngarde SystemN Spine, Inc. · 2007 · Recalled

Most influential descendants

Showing 5 of 5 · See all
  • K061774Nfix II Pedicle Screw SystemN Spine, Inc. · 2006 · cites it directly2descendants
  • K080876DVX Spine SystemBk Meditech, Co., Ltd. · 2008 · cites it directly1descendant
  • K090424DVX Spine SystemBk Meditech, Co., Ltd. · 2009 · 2 generations on0descendants
  • K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008 · 2 generations on0descendants
  • K072685Ngarde SystemN Spine, Inc. · 2007 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K053623Nfix Fusion SystemN-Spine, Inc.2006—
+1K061774Nfix II Pedicle Screw SystemN Spine, Inc.20067
+1K080876DVX Spine SystemBk Meditech, Co., Ltd.2008—
+2K090424DVX Spine SystemBk Meditech, Co., Ltd.2009—
+2K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.2008—
+2K072685Ngarde SystemN Spine, Inc.20079

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200820
200910
FIG. 1 — Lineage of K053623, 2006–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 MNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Moss Miami Spinal System
Named without a submission number
—

What descends from it? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061774Nfix II Pedicle Screw SystemN Spine, Inc.20062
K080876DVX Spine SystemBk Meditech, Co., Ltd.20081

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K061774 (N Spine, Inc., 2006) has gone furthest, with 2 descendants of its own.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

What is it indicated for?

NFix Indications for Use: The NFix Fusion System is intended for posterior, noncervical, pedicle fixation in order to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture…

Read the full statement (134 words)

NFix Indications for Use:

The NFix Fusion System is intended for posterior, noncervical, pedicle fixation in order to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the NFix Fusion System is intended for skeletally mature with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.

Indications for use as stated in the FDA summary.

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K053623 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053623: Nfix Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053623

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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