# K980485: Isola Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: Oct 21, 1998 after 254 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
No predicates in its family tree.
643 later devices descend from it; 14 cite it directly.
1 of 644 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Townley Screw: named in the summary without a submission number
- (no number) CD Spinal 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
The Posterior ISOLA Spinal System, when used with pedicle screws, is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine. The Posterior ISOLA Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1. The Posterior ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacralfiliac screw fixation from T1 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 surgery. The Anterior ISOLA system is intended for use in correcting scoliotic, lordotic or kyphotic spinal deformities by establishing an axially and rotationally rigid fixation bridge parallel to the long axis of the spine. The system is indicated in situations where loss of correction is expected, where severe scoliosis exists or where pelvic obliquity is present. The Anterior ISOLA system is used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Specific indications include: 1. Collapsing and unstable paralytic deformity. 2. Progressively increasing scoliosis. 3. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse. 4. Inability to maintain sitting balance, necessitating the use of the hands. 5. Increasing pelvic obliquity coincident with back pain or loss of sitting balance. 6. Spinal fractures (acute reduction or late deformity) 7. Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). 8. Spinal tumor 9. Previous failed fusion surgery. Spinal levels for Anterior ISOLA instrumentation are from T5-L4.

Source page: https://510kreport.com/device/K980485
Methodology: https://510kreport.com/methodology