510(k) Report

510(k) · Cleared

Cleared

True Spinal Fussion System

K133690510(k) TraditionalCleared May 7, 2014156-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

Innovative Surgical Designs · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on May 7, 2014 as substantially equivalent to K031655 (Medtronic Sofamor Danek USA, Inc., 2003) and 6 other predicates after a 156-day review. Its family tree reaches back 5 generations to 1990.

Decided
May 7, 2014
Review
156 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
7

Its longest line of descent runs back 5 generations to K901587 (1990). 26 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2003: 1 other ancestor2002: 1 other ancestor1999: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1995: 2 other ancestors1994: 2 other ancestors1993: 2 other ancestors1992: 5 other ancestors1990: 1 other ancestorK901587 · TSRH Sacral L-Connector · Danek Medical, Inc. · 1990K950099 · Synergy (TM) TI Posterior Spinal System · Buckman Co., Inc. · 1997×2: 2 generations cleared close together, K973836 (1998), K974749 (1998) K130958 · True Spinal Fixation System · Innovative Surgical Designs · 2013199019952000200520102015
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 17 other ancestors K130958 · True Spinal Fixation System · Innovative Surgical Designs · 2013K974749 · Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems · Cross Medical Products, Inc. · 1998K973836 · Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy Anterior Spinal System · Cross Medical Products, Inc. · 1998K950099 · Synergy (TM) TI Posterior Spinal System · Buckman Co., Inc. · 1997K901587 · TSRH Sacral L-Connector · Danek Medical, Inc. · 1990−50
  1. Root · 5 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
  2. 4 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
  3. 3 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
  4. 2 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
  5. 1 generation backK130958 True Spinal Fixation SystemInnovative Surgical Designs · 2013
  6. This deviceK133690 True Spinal Fussion SystemInnovative Surgical Designs · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K901587TSRH Sacral L-ConnectorDanek Medical, Inc.1990—
−4K950099Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc.1997—
−3K973836Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross…Cross Medical Products, Inc.1998—
−2K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy…Cross Medical Products, Inc.1998—
−1K130958True Spinal Fixation SystemInnovative Surgical Designs2013—
0 (this device)K133690True Spinal Fussion SystemInnovative Surgical Designs2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199250
199320
199420
199520
199610
199710
199810
199910
200010
200110
200210
200310
200410
FIG. 1 — Lineage of K133690, 1990–2014Source: 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.

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  • 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? (7)

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
*K031655CD Horizon Spinal System
Summary page 1
…scribed by ASTM F136. TrueTM Spinal Fixation System instruments are manufactured from 17-4 stainless steel ASTM F899 and Gray IXEF GY5i. Predicate Devices: CD HORIZON(@ (K031655/K041460), Moss®@ Miami (K992168/K022623) and the Synergy TM VLS (K9500991K974749) and True TM(K130958) Performance Data: Static…
Medtronic Sofamor Danek USA, Inc.20031
*K041460CD Horizon Spinal System
Summary page 1
…by ASTM F136. TrueTM Spinal Fixation System instruments are manufactured from 17-4 stainless steel ASTM F899 and Gray IXEF GY5i. Predicate Devices: CD HORIZON(@ (K031655/K041460), Moss®@ Miami (K992168/K022623) and the Synergy TM VLS (K9500991K974749) and True TM(K130958) Performance Data: Static compress…
Medtronic Sofamor Danek USA, Inc.2004—
*K992168Moss Miami 6.35MM Polyaxial Screw
Summary page 1
…nal Fixation System instruments are manufactured from 17-4 stainless steel ASTM F899 and Gray IXEF GY5i. Predicate Devices: CD HORIZON(@ (K031655/K041460), Moss®@ Miami (K992168/K022623) and the Synergy TM VLS (K9500991K974749) and True TM(K130958) Performance Data: Static compression bending and torsion,…
Depuyacromed1999—
*K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)
Summary page 1
…tion System instruments are manufactured from 17-4 stainless steel ASTM F899 and Gray IXEF GY5i. Predicate Devices: CD HORIZON(@ (K031655/K041460), Moss®@ Miami (K992168/K022623) and the Synergy TM VLS (K9500991K974749) and True TM(K130958) Performance Data: Static compression bending and torsion, and dyn…
Depuyacromed2002—
*K950099Synergy (TM) TI Posterior Spinal System
Summary page 1
…actured from 17-4 stainless steel ASTM F899 and Gray IXEF GY5i. Predicate Devices: CD HORIZON(@ (K031655/K041460), Moss®@ Miami (K992168/K022623) and the Synergy TM VLS (K9500991K974749) and True TM(K130958) Performance Data: Static compression bending and torsion, and dynamic compression bending tests we…
Buckman Co., Inc.1997—
*K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…
Summary page 1
…from 17-4 stainless steel ASTM F899 and Gray IXEF GY5i. Predicate Devices: CD HORIZON(@ (K031655/K041460), Moss®@ Miami (K992168/K022623) and the Synergy TM VLS (K9500991K974749) and True TM(K130958) Performance Data: Static compression bending and torsion, and dynamic compression bending tests were perfo…
Cross Medical Products, Inc.1998—
*K130958True Spinal Fixation System
Summary page 1
…teel ASTM F899 and Gray IXEF GY5i. Predicate Devices: CD HORIZON(@ (K031655/K041460), Moss®@ Miami (K992168/K022623) and the Synergy TM VLS (K9500991K974749) and True TM(K130958) Performance Data: Static compression bending and torsion, and dynamic compression bending tests were performed according to AST…
Innovative Surgical Designs2013—

Also cleared against K031655: 24 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 24 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
  • 1 of the 26 ancestors has a recall of any class.
  • 24 other devices also cite its predicate K031655.

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 Truetm Spinal Fixation System is intended for posterior, noncervical (Ti-Si) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K031655

24 other devices cite the same predicate.

  • K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine · 2025
  • K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG · 2015
  • K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  • K133402K2M Modular HooksK2m, Inc. · 2014
  • K133103Aversion Pedicle Screw SystemK7, LLC · 2014
  • K130958True Spinal Fixation SystemInnovative Surgical Designs · 2013

More from Innovative Surgical Designs

2 FDA decisions under this applicant name. See the company

  • K130958True Spinal Fixation SystemInnovative Surgical Designs · 2013

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/K133690 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133690: True Spinal Fussion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133690

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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