510(k) Report

510(k) · Cleared

Cleared

Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549)

K091725510(k) TraditionalCleared Nov 9, 2009151-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

U&I Corp. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Nov 9, 2009 as substantially equivalent to K024096 (U&I Corp., America, 2003) after a 151-day review. Its family tree reaches back 3 generations to 2000. 150 later devices descend from it.

Decided
Nov 9, 2009
Review
151 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K000319 (2000). 5 ancestors in all. 150 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors2010: 3 descendants cleared2011: 2 descendants cleared2019: 5 descendants cleared2012: 8 descendants cleared2013: 3 descendants cleared2016: 6 descendants cleared2023: 20 descendants cleared2022: 10 descendants cleared2020: 12 descendants cleared2026: 15 descendants cleared2024: 15 descendants cleared2015: 8 descendants cleared2018: 12 descendants cleared2014: 5 descendants cleared2021: 8 descendants cleared2017: 6 descendants cleared2025: 12 descendants clearedK000319 · Ebi Xfix DFS System · Ebi, L.P. · 2000K020279 · Forex Corporation, Optima, Spinal System · Forex Corp. · 2002 · recalledK024096 · Optima, Spinal System · U&I Corp., America · 2003 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 16 descendants3 generations forward: 17 descendants4 generations forward: 20 descendants5 generations forward: 25 descendants6 generations forward: 21 descendants7 generations forward: 15 descendants8 generations forward: 14 descendants9 generations forward: 12 descendants10 generations forward: 6 descendants K024096 · Optima, Spinal System · U&I Corp., America · 2003 · recalledK020279 · Forex Corporation, Optima, Spinal System · Forex Corp. · 2002 · recalledK000319 · Ebi Xfix DFS System · Ebi, L.P. · 20000+5+10
  1. Root · 3 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
  2. 2 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
  3. 1 generation backK024096 Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
  4. This deviceK091725 Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020…U&I Corp. · 2009
  5. Descendant · cites it directly · 123 of its ownK103085 Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011
  6. Descendant · 2 generations on · 111 of its ownK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
  7. Descendant · 2 generations on · 75 of its ownK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
  8. Descendant · 3 generations on · 70 of its ownK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  9. Descendant · 3 generations on · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled

Showing 5 of 150 descendants. See all descendants

Descendants cleared per year

2010: 32011: 22012: 82013: 32014: 52015: 82016: 62017: 62018: 122019: 52020: 122021: 82022: 102023: 202024: 152025: 122026: 15
2010high 20 (2023) · low 2 (2011)2026

Most influential descendants

Showing 5 of 150 · See all
  • K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011 · cites it directly123descendants
  • K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012 · 2 generations on111descendants
  • K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 2 generations on75descendants
  • K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 3 generations on70descendants
  • K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 3 generations on67descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K000319Ebi Xfix DFS SystemEbi, L.P.2000—
−2K020279Forex Corporation, Optima, Spinal SystemForex Corp.20024
−1K024096Optima, Spinal SystemU&I Corp., America20033
0 (this device)K091725Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549)U&I Corp.2009—
+1K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd.2011—
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)20132
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2013—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)20141

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201030
201120
201280
201330
201450
201580
201660
201760
2018120
201950
2020120
202180
2022100
2023200
2024150
2025120
2026150
FIG. 1 — Lineage of K091725, 2000–2026Source: 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
*K024096Optima, Spinal System
Summary page 1
…Fixation Fixation Orthosis (KWP), per 21 CFR 888.3050 Product Code: MNH, MNI, KWP Predicate Devices: OPTIMATM Spinal System (K024096) Description of Device: The PerfixTM Spinal System is manufactured by U&I corporation. The PerfixTM is a top-loading multiple c…
U&I Corp., America20033

Also cleared against K024096: 29 other devices →

What descends from it? (150)

See all 150

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

NumberDeviceApplicantDecidedDescendants
K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd.2011123
K100956Spondy Spinal Fixation SystemAllure Spine LLC201017
K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910
K100575LDR Spine Usa Spine Tune TL Spine SystemLdr Spine USA20107

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?

  • The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
  • 2 of the 5 ancestors have a recall of any class.
  • Of its descendants, K103085 (L&K BIOMED Co., Ltd., 2011) has gone furthest, with 123 descendants of its own.
  • 29 other devices also cite its predicate K024096.

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. 2009, this device’s year, is highlighted.

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?

The PerfixTM Spinal System is a posterior, noncervical pedicle fixation system

intended to provide immobilization and stabilization of spinal segments in skeletally-

mature patients as an adjunct to fusion by autogenous bone graft in the treatment of

the following acute and chronic instabilities or deformities of thoracic, lumbar and

sacral spine:

* Spondylolisthesis (Grade 3 and 4)

* Degenerative spondylolisthesis with objective evidence of neurological

impairment

• Trauma (i.e., fracture or dislocation)

* Spinal stenosis

* Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)

* Tumor

* Pseudoarthrosis

* Failed previous fusion

Indications for use as stated in the FDA summary.

Also cleared against K024096

29 other devices cite the same predicate.

  • K231737ANAX™ 5.5 Spinal SystemInnosys Co., Ltd. · 2023
  • K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC · 2018
  • K153404Zavation Spinal SystemZavation, LLC · 2016
  • K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH · 2016
  • K143417ANAX 5.5 Spinal SystemU&I Corporation · 2015
  • K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc. · 2015

More from U&I Corp.

12 FDA decisions under this applicant name. See the company

  • K140864Veloxtm Interbody Fusion SystemU&I Corp. · 2014
  • K140234Aspiron Acp SystemU&I Corp. · 2014
  • K132926Velofixtm Interbody Fusion SystemU&I Corp. · 2014
  • K120419Dyna Locking Ankle NailU&I Corp. · 2012
  • K112240Dyna Locking Cannulated ScrewU&I Corp. · 2012

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/K091725 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091725: Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091725

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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