510(k) Report

510(k) · Cleared

Cleared

Timx Low Back System Titanium MX Rod Based Low Back System

K981714510(k) TraditionalCleared Jun 30, 199846-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

Acromed Corp. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Jun 30, 1998 as substantially equivalent to K952236 (Acromed Corp., 1996) after a 46-day review. Its family tree reaches back 1 generation to 1996. 1 of the 599 devices in its family, counting itself, has a Class I recall. 597 later devices descend from it.

Decided
Jun 30, 1998
Review
46 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K952236 (1996). 597 later devices descend from it, 1 citing it directly. 1 of the 599 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2001: 2 descendants cleared2010: 9 descendants cleared2006: 3 descendants cleared2019: 35 descendants cleared2004: 1 descendant cleared2002: 2 descendants cleared2008: 7 descendants cleared2003: 1 descendant cleared2013: 25 descendants cleared2005: 2 descendants cleared2009: 7 descendants cleared2007: 4 descendants cleared2021: 31 descendants cleared, 1 with a Class I recall12016: 24 descendants cleared2014: 24 descendants cleared2011: 7 descendants cleared2012: 21 descendants cleared2015: 31 descendants cleared2018: 41 descendants cleared2017: 36 descendants cleared2020: 38 descendants cleared2025: 51 descendants cleared2022: 38 descendants cleared2023: 56 descendants cleared2024: 54 descendants cleared2026: 47 descendants clearedReference device: K981274 · Acromed Timx Plate Based Low Back System · Acromed Corp. · 1998Reference device: K965046 · Isola Twister Connector · Acromed Corp. · 1997K952236 · Isola System · Acromed Corp. · 19961995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 11 descendants3 generations forward: 43 descendants4 generations forward: 82 descendants5 generations forward: 116 descendants6 generations forward: 124 descendants, 1 with a Class I recall17 generations forward: 97 descendants8 generations forward: 56 descendants9 generations forward: 39 descendants10 generations forward: 20 descendants11 generations forward: 5 descendants12 generations forward: 3 descendants K952236 · Isola System · Acromed Corp. · 19960+5+10
  1. Root · 1 generation backK952236 Isola SystemAcromed Corp. · 1996
  2. This deviceK981714 Timx Low Back System Titanium MX Rod Based Low Back SystemAcromed Corp. · 1998
  3. Descendant · cites it directly · 596 of its ownK010576 Monarch Spine SystemDepuyacromed · 2001
  4. Descendant · 2 generations on · 578 of its ownK024348 Monarch Spine SystemDepuyacromed · 2003
  5. Descendant · 2 generations on · 496 of its ownK021148 Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed · 2002
  6. Descendant · 3 generations on · 495 of its ownK052131 Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005
  7. Descendant · 2 generations on · 490 of its ownK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006

Showing 5 of 597 descendants. See all descendants

Descendants cleared per year

2001: 22002: 22003: 12004: 12005: 22006: 32007: 42008: 72009: 72010: 92011: 72012: 212013: 252014: 242015: 312016: 242017: 362018: 412019: 352020: 382021: 312022: 382023: 562024: 542025: 512026: 47
2001high 56 (2023) · low 1 (2003)2026

Class I recalls in this family

  • K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 597 · See all
  • K010576Monarch Spine SystemDepuyacromed · 2001 · cites it directly596descendants
  • K024348Monarch Spine SystemDepuyacromed · 2003 · 2 generations on578descendants
  • K021148Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed · 2002 · 2 generations on496descendants
  • K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005 · 3 generations on495descendants
  • K062174Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · 2 generations on490descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K952236Isola SystemAcromed Corp.1996—
0 (this device)K981714Timx Low Back System Titanium MX Rod Based Low Back SystemAcromed Corp.1998—
+1K010576Monarch Spine SystemDepuyacromed2001—
+2K024348Monarch Spine SystemDepuyacromed2003—
+2K021148Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed2002—
+3K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc.2005—
+2K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200120
200220
200310
200410
200520
200630
200740
200870
200970
201090
201170
2012210
2013250
2014240
2015310
2016240
2017360
2018410
2019350
2020380
2021311
2022380
2023560
2024540
2025510
2026470
FIG. 1 — Lineage of K981714, 1996–2026Source: 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.

1 device in this family has a Class I recall. 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? (2)

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
*K952236Isola System
Summary page 1
…ing to ASTM F-136 specifications. The TiMX Pedicle Screw is a variation of the existing titanium alloy pedicle screw previously cleared for the Isola Spinal System under K952236 and is the same screw that was found substantially equivalent for usr, with plates in K981274. The machine thread portion of the…
Acromed Corp.1996—
*—Harrington System
Named without a submission number
—
†K981274Acromed Timx Plate Based Low Back SystemAcromed Corp.1998—
†K965046Isola Twister ConnectorAcromed Corp.1997—

Also cleared against K952236: 4 other devices →

What descends from it? (597)

See all 597

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

NumberDeviceApplicantDecidedDescendants
K010576Monarch Spine SystemDepuyacromed2001596

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K010576 (Depuyacromed, 2001) has gone furthest, with 596 descendants of its own.
  • 4 other devices also cite its predicate K952236.

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?

When labeled for pedicle screw fixation, the TIMX Low Back System is intended for use in Grade 3 and 4 spondylolisthesis at L5-S1, when affixed to the lumbosacral spine, utilizing autologous bone graft, and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum. When labeled for non-pedicle screw posterior fixation, the TiMX Low Back System is intended for hook, wire and/or sacral/iliac…

Read the full statement (188 words)

When labeled for pedicle screw fixation, the TIMX Low Back System is intended for use in Grade 3 and 4 spondylolisthesis at L5-S1, when affixed to the lumbosacral spine, utilizing autologous bone graft, and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum.

When labeled for non-pedicle screw posterior fixation, the TiMX Low Back System is intended for hook, wire and/or sacral/iliac screw fixation from the thoracic spine to the ilium/sacrum. Properly used, the posterior TIMX Low Back System will provide temporary stabilization as an adjunct to spinal bone grafting process. Specific indications are:

1. Idiopathic scoliosis.

2. Neuromuscular scoliosis/ kyphoscoliosis with associated paralysis or spasticity.

3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.

4. Spinal fractures (acute reduction or late deformity).

5. Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).

6. Spondylolisthesis.

7. Neoplastic disease.

8. Previous Failed Fusion.

Levels of attachment for these indications range from T1 to the sacrum. This system is intended for single use.

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 K952236

4 other devices cite the same predicate.

  • K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System…Medos International SARL · 2019
  • K063772Expedium Spine SystemDepuy Spine, Inc. · 2007
  • K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
  • K981113Pediatric PRCAcromed Corp. · 1998

More from Acromed Corp.

41 FDA decisions under this applicant name. See the company

  • K980485Isola Spinal SystemAcromed Corp. · 1998
  • K981113Pediatric PRCAcromed Corp. · 1998
  • K981274Acromed Timx Plate Based Low Back SystemAcromed Corp. · 1998
  • K980228University Plate Anterior SystemAcromed Corp. · 1998
  • K974757Kaneda Anterior Scoliosis System KassAcromed Corp. · 1998

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/K981714 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981714: Timx Low Back System Titanium MX Rod Based Low Back System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981714

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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