# K022285: Modification to Isola Spinal System

- Pathway: 510(k) (Special)
- Applicant: Depuyacromed
- Decided: Aug 13, 2002 after 29 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: 1 generation back to K980485 (1998). 1 ancestor in all.
403 later devices descend from it; 7 cite it directly.
1 of 405 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980485: Isola Spinal System, Acromed Corp. (1998) Summary page 1.

## Most influential descendants
- K073126: Expedium Spine System (2007), 304 descendants of its own
- K082195: Modifications to Expedium Spine System (2008), 269 descendants of its own
- K092473: Expedium Spine System (2009), 263 descendants of its own
- K101070: Expedium Spine System (2010), 260 descendants of its own
- K122226: Revere Stabilization System (2012), 225 descendants of its own

## Indications for use
The ISOLA Spinal 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 ISOLA Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-SI 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 ISOLA Spinal System is also a hook and sacralliliac 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 ISOLA Spinal, System 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.

Source page: https://510kreport.com/device/K022285
Methodology: https://510kreport.com/methodology