510(k) · Cleared
ClearedAcromed Timx Plate Based Low Back System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acromed Corp. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Apr 29, 1998 as substantially equivalent to K944736 (Acromed Corp., 1995) after a 21-day review. Its family tree reaches back 1 generation to 1995. 1 of the 599 devices in its family, counting itself, has a Class I recall. 597 later devices descend from it.
- Decided
- Apr 29, 1998
- Review
- 21 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944736 (1995). 597 later devices descend from it, 2 citing it directly. 1 of the 599 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK944736 VSP (Variable Screw Placement)Acromed Corp. · 1995
- This deviceK981274 Acromed Timx Plate Based Low Back SystemAcromed Corp. · 1998
- Descendant · cites it directly · 596 of its ownK010576 Monarch Spine SystemDepuyacromed · 2001
- Descendant · 2 generations on · 578 of its ownK024348 Monarch Spine SystemDepuyacromed · 2003
- Descendant · 2 generations on · 496 of its ownK021148 Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed · 2002
- Descendant · 3 generations on · 495 of its ownK052131 Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005
- 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
Class I recalls in this family
- K211616 ExcelsiusHub5 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944736 | VSP (Variable Screw Placement) | Acromed Corp. | 1995 | — |
| 0 (this device) | K981274 | Acromed Timx Plate Based Low Back System | Acromed Corp. | 1998 | — |
| +1 | K010576 | Monarch Spine System | Depuyacromed | 2001 | — |
| +2 | K024348 | Monarch Spine System | Depuyacromed | 2003 | — |
| +2 | K021148 | Monarch Spine System Commercially Pure Titanium Spinal Rod | Depuyacromed | 2002 | — |
| +3 | K052131 | Expedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods | Depuy Spine, Inc. | 2005 | — |
| +2 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 7 | 0 |
| 2012 | 21 | 0 |
| 2013 | 25 | 0 |
| 2014 | 24 | 0 |
| 2015 | 31 | 0 |
| 2016 | 24 | 0 |
| 2017 | 36 | 0 |
| 2018 | 41 | 0 |
| 2019 | 35 | 0 |
| 2020 | 38 | 0 |
| 2021 | 31 | 1 |
| 2022 | 38 | 0 |
| 2023 | 56 | 0 |
| 2024 | 54 | 0 |
| 2025 | 51 | 0 |
| 2026 | 47 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K944736 | VSP (Variable Screw Placement)Summary page 1…d, preamendment device system DESCRIPTION: The TiMX Plate Based Low Back System is a variation of the existing titanium alloy VSP Spinal System previously cleared under K944736. The TiMX Plate Based Low Back System is a construct that consists of pedicle and sacral screws, spine plates, nuts, washers and… | 1995 |
| * | — | Harrington System, manufactured by Zimmer Named without a submission number | |
| † | K951116 | Acromed Pedicle Screw | 1995 |
What descends from it? (597)
See all 5972 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Titanium MX Low Back System is intended for use in Grade 3 and 4 spondylolisthesis at 1.5-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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981274: Acromed Timx Plate Based Low Back System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981274
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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