510(k) Report

510(k) · Cleared

Cleared

Timx Spinal Systems

K013295510(k) SpecialCleared Oct 9, 20017-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

Depuyacromed · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Oct 9, 2001 as substantially equivalent to K983583 (Depuy, Inc., 1998) and 2 other predicates after a 7-day review. Its family tree reaches back 1 generation to 1998.

Decided
Oct 9, 2001
Review
7 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K983583 (1998). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 2 other ancestorsK983583 · Depuy Acromed Moss and Moss Miami Spinal Systems · Depuy, Inc. · 19981996199820002002
Other ancestors, by generation 1 generation back: 2 other ancestors K983583 · Depuy Acromed Moss and Moss Miami Spinal Systems · Depuy, Inc. · 19980
  1. Root · 1 generation backK983583 Depuy Acromed Moss and Moss Miami Spinal SystemsDepuy, Inc. · 1998
  2. This deviceK013295 Timx Spinal SystemsDepuyacromed · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K983583Depuy Acromed Moss and Moss Miami Spinal SystemsDepuy, Inc.1998—
0 (this device)K013295Timx Spinal SystemsDepuyacromed2001—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
FIG. 1 — Lineage of K013295, 1998–2001Source: 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? (3)

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
*K983583Depuy Acromed Moss and Moss Miami Spinal Systems
Summary page 1
…. Gilman August 28, 2001 Appliance, Fixation, Spinal Interlaminal Orthosis, Spinal Pedicle Fixation TIMX Spine System MOSS MIAMI! Spinal System Transverse Connector (K983583) EZ-Link Transverse Connector (K001372, K001470) The CrossOver Cross Connector is designed to transversely connect two rods used…
Depuy, Inc.1998—
*K001372E-Z Link Cross Connector
Summary page 1
…xation, Spinal Interlaminal Orthosis, Spinal Pedicle Fixation TIMX Spine System MOSS MIAMI! Spinal System Transverse Connector (K983583) EZ-Link Transverse Connector (K001372, K001470) The CrossOver Cross Connector is designed to transversely connect two rods used in spinal instrumentation constructs.…
Depuyacromed2000—
*K001470E-Z Link Cross Connector
Summary page 1
…pinal Interlaminal Orthosis, Spinal Pedicle Fixation TIMX Spine System MOSS MIAMI! Spinal System Transverse Connector (K983583) EZ-Link Transverse Connector (K001372, K001470) The CrossOver Cross Connector is designed to transversely connect two rods used in spinal instrumentation constructs. The conne…
Depuyacromed2000—

Also cleared against K983583: 25 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?

  • None of the 3 ancestors has a recall.
  • 25 other devices also cite its predicate K983583.

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?

The TIMX Spine System is a pedicle screw system intended 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous…

Read the full statement (180 words)

The TIMX Spine System is a pedicle screw system intended 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The TIMX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 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 sacrum) with removal of the implants after the attainment of a solid fusion.

The TIMX Spine System is also a hook and sacralfiliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K983583

25 other devices cite the same predicate.

  • K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System…Medos International SARL · 2019
  • K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd. · 2017
  • K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A. · 2016
  • K160926F1 MPS Modular Pedicle Screw SystemDegen Medical · 2016
  • K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014
  • K133287Presson Spinal Fixation SystemNexus Spine, LLC · 2014

More from Depuyacromed

48 FDA decisions under this applicant name. See the company

  • K040197Eagle Anterior Cervial Plate SystemDepuyacromed · 2004
  • K031635Depuy Acromed VBR SystemDepuyacromed · 2003
  • K030833Depuy Acromed VBR SystemDepuyacromed · 2003
  • K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
  • K030249Surgical Titanium Mesh SystemDepuyacromed · 2003

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/K013295 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013295: Timx Spinal Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013295

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026