# K970950: Easy Rod

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: Jun 3, 1997 after 81 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 K944737 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944737: Isola Spine System, Acromed Corp. (1995) Summary page 1.
- (no number) Harrington System: named in the summary without a submission number

## Indications for use
The Easy Rod is 2 variarion of the % inch diameter ISOLA rod of the ISOLA Spine System. This rod offers the surgeon casicr contourebility and casicr in-sit bending compared with cxisting ¥ inch diamcter ISOLA rods. The ISOLA System consists of two sub-systems: The Poswnor 1SOLA. sysmm and the Anterior ISOLA-System “The Easy Rod is intended to be used with the Posterior ISOLA System atthistime. The ISOLA implants, when used with pedicle screws, are intended for use in Grade 3 or 4 spondylolisthesis at L35-S1 utilizing anologous bone eraft, having the device fixed or attached to the lumbar and sacral spinc and intended w be removed after solid fusion is amained. When not used with pedicle screws, the ISOLA System is intended for hook. wire, and/or sacral/iliac screw fixation fom the T1 to the ilium/sacrum. The non pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as :fiscogemc back pain with degencration of the disc confirmed by historv and radiographic studics), deformities (scoliosis, lordosis and hphos:s). twmor, fracture and previous failed surgery. As a whole, the Posterior ISOLA spinal system is intended for T1-sacral fixation. Pedicle screw fixation is from L3-S1. The Anterior ISOLA system is intended for nse in correcting scoliotic, lordetic or kyphotic spinal deformities by establishing an axially and rotationally rigid fixetion bridge parallel to the long axis of the spine. The Anterior system is indicated in situations where loss of correction is ¢xpected, where severe scoliosis exists or where pelvic obliquity is present. Spinal levels for anterior instrumentation are from TS-1L4. Properly used, the Posterior and Anterior ISOLA Systems will provids temporary stbilization as an adjunct to spinal bone grafting processes. Specific indications are: Idiopathic scoliosis. Neuramuscular scoliosis/kyphoscoliosis with associated paralysis or spacisticity. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele. Spinal fractures (acute reduction of late deformity). Degenerative disc disease (defined s discogenic back pain with degneration of the disc confirmed by history and radiographic studies). Neaplastic discase, Revision surpery. The Anterior [SOLA system is also 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. Indications for these scoliotic uses include: Collapsing and unstable paralytic deformity. Progressively increasing scoliosis. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse. Inability to mainuain siting balance, necessitating the use of the hands. Increasing pelvic obliquity coincident with back pain or loss of sifting balance.

Source page: https://510kreport.com/device/K970950
Methodology: https://510kreport.com/methodology