# K010576: Monarch Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Depuyacromed
- Decided: May 23, 2001 after 85 days
- Product code: MNI (Orthosis, Spinal Pedicle 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: 2 generations back to K944736 (1995). 7 ancestors in all.
596 later devices descend from it; 11 cite it directly.
1 of 604 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981274: Acromed Timx Plate Based Low Back System, Acromed Corp. (1998) Summary page 1.
- K981714: Timx Low Back System Titanium MX Rod Based Low Back System, Acromed Corp. (1998) Summary page 1.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 1.
- K983583: Depuy Acromed Moss and Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 1.
- K980485: Isola Spinal System, Acromed Corp. (1998) Summary page 1.

## Most influential descendants
- 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
- K063156: Modification to Expedium Spine System (2006), 424 descendants of its own

## Indications for use
The Monarch 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 Monarch 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 Monarch Spine System is also a hook and sacral/iliac 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). The Monarch Spine System Dual Rod Connectors can be used to connect Monarch Spine System Rods to rods of other DePuy AcroMed 4.75mm, 5.5mm, and 6.35mm diameter rod systems.

Source page: https://510kreport.com/device/K010576
Methodology: https://510kreport.com/methodology