# K965046: Isola Twister Connector

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: Mar 14, 1997 after 86 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have 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) ISOLA Twister Connector manufactured from implant grade stainless steel: named in the summary without a submission number
- (no number) other AcroMed Slotted Connectors: named in the summary without a submission number

## Indications for use
The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spoadylolisthesis at the fifth lumbar - first sacral vertebral (LS-S1) joint utilizing atologous bone graft, having the device fixed or attached to the Jumbar and sacral spine and intended to be removed after solid fixsion is attained. The ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacralfiliac screw fixation from T1 to 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 surgery. As a whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-S1.

Source page: https://510kreport.com/device/K965046
Methodology: https://510kreport.com/methodology