# K981714: Timx Low Back System Titanium MX Rod Based Low Back System

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: Jun 30, 1998 after 46 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 K952236 (1996). 1 ancestor in all.
597 later devices descend from it; 1 cites 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)
- K952236: Isola System, Acromed Corp. (1996) Summary page 1.
- (no number) Harrington System: 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
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.

Source page: https://510kreport.com/device/K981714
Methodology: https://510kreport.com/methodology