# K021335: Monarch Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Depuyacromed
- Decided: Jul 11, 2002 after 76 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 K993030 (1999). 2 ancestors in all.
581 later devices descend from it; 4 cite it directly.
1 of 584 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993030: Modification to Isola Spinal System, Depuyacromed (1999) Summary page 1.
- K011830: Tri-Fix Spinal Fixation System, Endius, Inc. (2001)

## Most influential descendants
- K024348: Monarch Spine System (2003), 578 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
- K063741: Expedium Spine System (2007), 398 descendants of its own

## Indications for use
The MONARCH Spine Syster'n when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine. The MONARCH Spine System when used with pedicle screws is indicated for degenerative spodylolisthesis with objective evidence of neucologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine. The MONARCH Spine System is also indicated for pedicle screw fixation for Grade 3 and 4 spondylolisthesis at L5-S1, in skeletally mature patients, utilizing autologous bone graft, having the device fixed or attached to the lumbar or sacral spine and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum. The MONARCH Spine System when not used with pedicle screws is intended for posterior hook, wire, and/or sacral/iliac screw fixation from T I to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed fusion.

Source page: https://510kreport.com/device/K021335
Methodology: https://510kreport.com/methodology