# K981274: Acromed Timx Plate Based Low Back System

- Pathway: 510(k) (Special)
- Applicant: Acromed Corp.
- Decided: Apr 29, 1998 after 21 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944736 (1995). 1 ancestor in all.
597 later devices descend from it; 2 cite it directly.
1 of 599 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944736: VSP (Variable Screw Placement), Acromed Corp. (1995) Summary page 1.
- (no number) Harrington System, manufactured by Zimmer: named in the summary without a submission number

## Most influential descendants
- K010576: Monarch Spine System (2001), 596 descendants of its own
- K024348: Monarch Spine System (2003), 578 descendants of its own
- K021148: Monarch Spine System Commercially Pure Titanium Spinal Rod (2002), 496 descendants of its own
- K052131: Expedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods (2005), 495 descendants of its own
- K062174: Modification to Expedium Spine System (2006), 490 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K981274
Methodology: https://510kreport.com/methodology