510(k) Report

510(k) · Cleared

Cleared

Presson Spinal Fixation System

K133287510(k) TraditionalCleared Feb 25, 2014123-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

Nexus Spine, LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Feb 25, 2014 as substantially equivalent to K061577 (Signus Medizintechnik GmbH, 2006) and 4 other predicates after a 123-day review. Its family tree reaches back 6 generations to 2004. 1 later device descends from it.

Decided
Feb 25, 2014
Review
123 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
5

Its longest line of descent runs back 6 generations to K040583 (2004). 27 ancestors in all, the oldest K982990 (1998). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2006: 2 other ancestors1999: 2 other ancestors1998: 2 other ancestors2005: 1 other ancestor2004: 3 other ancestors2003: 3 other ancestors2002: 3 other ancestors2001: 1 other ancestor2000: 3 other ancestors2016: 1 descendant cleared×3: 3 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004) K052054 · TSRH Spinal System · Medtronic Sofamor Danek · 2005K072317 · Modification to:TSRH Spinal System · Medtronic Sofamor Danek USA, Inc. · 2007 · recalledK081080 · TSRH Spinal System · Medtronic Sofamor Danek · 20081995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors3 generations back: 15 other ancestors4 generations back: 2 other ancestors 1 generation forward: 1 descendant K081080 · TSRH Spinal System · Medtronic Sofamor Danek · 2008K072317 · Modification to:TSRH Spinal System · Medtronic Sofamor Danek USA, Inc. · 2007 · recalledK052054 · TSRH Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−50
  1. Root · 6 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 5 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 4 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 3 generations backK052054 TSRH Spinal SystemMedtronic Sofamor Danek · 2005
  5. 2 generations backK072317 Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2007 · Recalled
  6. 1 generation backK081080 TSRH Spinal SystemMedtronic Sofamor Danek · 2008
  7. This deviceK133287 Presson Spinal Fixation SystemNexus Spine, LLC · 2014
  8. Descendant · cites it directly · 0 of its ownK160820 PressON Pro Spinal Fixation SystemNexus Spine, LLC · 2016

Most influential descendants

Showing 1 of 1 · See all
  • K160820PressON Pro Spinal Fixation SystemNexus Spine, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−5K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−4K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−3K052054TSRH Spinal SystemMedtronic Sofamor Danek2005—
−2K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc.20074
−1K081080TSRH Spinal SystemMedtronic Sofamor Danek2008—
0 (this device)K133287Presson Spinal Fixation SystemNexus Spine, LLC2014—
+1K160820PressON Pro Spinal Fixation SystemNexus Spine, LLC2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199820
199920
200030
200110
200230
200330
200430
200510
200620
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K133287, 2004–2016Source: 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
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What was it cleared against? (5)

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
*K061577Ovaltwist Pedicle Screw System
Summary page 1
…o the following devices: Oval Twist Pedicle Screw System Signus Medizintechnik GMBH 5 10O(k) number K06 1577 DePuy AcroMed MOSS Miami Spinal System DePuy Acromed Inc. 5…
Signus Medizintechnik GmbH2006—
*K983583Depuy Acromed Moss and Moss Miami Spinal Systems
Summary page 1
…5 10O(k) number K06 1577 DePuy AcroMed MOSS Miami Spinal System DePuy Acromed Inc. 5 10O(k) number K983583 TSRH Spinal System Medtronic Sofamor Danek USA 5 10O(k) num…
Depuy, Inc.1998—
*K081080TSRH Spinal System
Summary page 1
…5 10O(k) number K983583 TSRH Spinal System Medtronic Sofamor Danek USA 5 10O(k) number K08 1080 EBI SpineL ink System E31, L.P. 5 10O(k) number K992920…
Medtronic Sofamor Danek2008—
*K992920Ebi Spinelink System
Summary page 1
…USA 5 10O(k) number K08 1080 EBI SpineL ink System E31, L.P. 5 10O(k) number K992920 Nu Vasive SpheRx DBR HI System NuVasive, Inc 5 10(k) number…
Ebi, L.P.1999—
*K083028Modification to: Nuvasive Spherx II System
Summary page 1
…5 10O(k) number K992920 Nu Vasive SpheRx DBR HI System NuVasive, Inc 5 10(k) number K083028 Device Description: The PressON Spinal Fixation System is composed of pedicle screws and rods. These c…
Nuvasive, Inc.2008—

Also cleared against K061577: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K160820PressON Pro Spinal Fixation SystemNexus Spine, LLC20160

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 10 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
  • 4 of the 27 ancestors have a recall of any class.
  • Of its descendants, K160820 (Nexus Spine, LLC, 2016) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K061577.

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. 2014, 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 PressON Spinal Fixation System is a posterior, non-cervical pedicle screw system intended to provide immobilization and stabilization of spinal segments that can accept a device construct up to 80mm in length 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…

Read the full statement (138 words)

The PressON Spinal Fixation System is a posterior, non-cervical pedicle screw system intended to provide immobilization and stabilization of spinal segments that can accept a device construct up to 80mm in length 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.

Indications for use as stated in the FDA summary.

Also cleared against K061577

3 other devices cite the same predicate.

  • K090477Alpine Pedicle Screw SystemSanacor · 2009
  • K081108Monopoly Pedicle Screw SystemSignus Medical, LLC · 2008
  • K070933Lowtop Pedicle Screw SystemSanacor · 2007

More from Nexus Spine, LLC

17 FDA decisions under this applicant name. See the company

  • K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC · 2025
  • K241467Stable-C Interbody SystemNexus Spine, LLC · 2024
  • K233375Tranquil-L Interbody SystemNexus Spine, LLC · 2024
  • K240416Tranquil-C Interbody SystemNexus Spine, LLC · 2024
  • K233234PressON Spinal Fixation SystemNexus Spine, LLC · 2023

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/K133287 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133287: Presson Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133287

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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