510(k) Report

510(k) · Cleared

Cleared

True Spinal Fixation System

K130958510(k) TraditionalCleared Oct 17, 2013195-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 · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Oct 17, 2013 as substantially equivalent to K031655 (Medtronic Sofamor Danek USA, Inc., 2003) and 5 other predicates after a 195-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it.

Decided
Oct 17, 2013
Review
195 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K901587 (1990). 25 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, 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 ancestor2014: 1 descendant clearedK901587 · 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) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 17 other ancestors 1 generation forward: 1 descendant K974749 · 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. · 19900
  1. Root · 4 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
  2. 3 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
  3. 2 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
  4. 1 generation backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
  5. This deviceK130958 True Spinal Fixation SystemInnovative Surgical Designs · 2013
  6. Descendant · cites it directly · 0 of its ownK133690 True Spinal Fussion SystemInnovative Surgical Designs · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K133690True Spinal Fussion SystemInnovative Surgical Designs · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K130958, 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.

Planning a device in MNI? 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? (6)

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
…M F136. True TM Spinal Fixation System instruments are manufactured from 17-4 stainless steel ASTM F899 and IXEF PARA GS-1 022. Predicate Devices: CID HORIZON®S (K031655/K0414601 Moss® Miami (K992168/K022623) and the Synergy TM VLS (K9500991K974749) Performance Data: Stati…
Medtronic Sofamor Danek USA, Inc.20031
*K041460CD Horizon Spinal System
Summary page 1
…True TM Spinal Fixation System instruments are manufactured from 17-4 stainless steel ASTM F899 and IXEF PARA GS-1 022. Predicate Devices: CID HORIZON®S (K031655/K0414601 Moss® Miami (K992168/K022623) and the Synergy TM VLS (K9500991K974749) Performance Data: Static compre…
Medtronic Sofamor Danek USA, Inc.2004—
*K992168Moss Miami 6.35MM Polyaxial Screw
Summary page 1
…anufactured from 17-4 stainless steel ASTM F899 and IXEF PARA GS-1 022. Predicate Devices: CID HORIZON®S (K031655/K0414601 Moss® Miami (K992168/K022623) and the Synergy TM VLS (K9500991K974749) Performance Data: Static compression bending and torsion, and dynamic compressi…
Depuyacromed1999—
*K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)
Summary page 1
…red from 17-4 stainless steel ASTM F899 and IXEF PARA GS-1 022. Predicate Devices: CID HORIZON®S (K031655/K0414601 Moss® Miami (K992168/K022623) and the Synergy TM VLS (K9500991K974749) Performance Data: Static compression bending and torsion, and dynamic compression bendi…
Depuyacromed2002—
*K950099Synergy (TM) TI Posterior Spinal System
Summary page 1
…M F899 and IXEF PARA GS-1 022. Predicate Devices: CID HORIZON®S (K031655/K0414601 Moss® Miami (K992168/K022623) and the Synergy TM VLS (K9500991K974749) Performance Data: Static compression bending and torsion, and dynamic compression bending tests were performed according…
Buckman Co., Inc.1997—
*K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…
Summary page 1
…nd IXEF PARA GS-1 022. Predicate Devices: CID HORIZON®S (K031655/K0414601 Moss® Miami (K992168/K022623) and the Synergy TM VLS (K9500991K974749) Performance Data: Static compression bending and torsion, and dynamic compression bending tests were performed according to ASTM…
Cross Medical Products, Inc.1998—

Also cleared against K031655: 24 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
K133690True Spinal Fussion SystemInnovative Surgical Designs20140

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 23 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
  • 1 of the 25 ancestors has a recall of any class.
  • Of its descendants, K133690 (Innovative Surgical Designs, 2014) has gone furthest, with 0 descendants of its own.
  • 24 other devices also cite its predicate K031655.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · MNI

1in 2017

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

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

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, 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
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—0—

What is it indicated for?

The True Spinal Fixation System is intended for posterior, noncervical (T1-S1) 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
  • K133690True Spinal Fussion SystemInnovative Surgical Designs · 2014
  • K133103Aversion Pedicle Screw SystemK7, LLC · 2014

More from Innovative Surgical Designs

2 FDA decisions under this applicant name. See the company

  • K133690True Spinal Fussion SystemInnovative Surgical Designs · 2014

Recent decisions in MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K130958 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130958: True 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/K130958

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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