# K962984: Isola Pediatric Components

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: Nov 27, 1996 after 118 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
587 later devices descend from it; 5 cite it directly.
1 of 588 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) other ISOLA Components: named in the summary without a submission number

## Most influential descendants
- K071668: Orthobiom Spinal System (2008), 582 descendants of its own
- K091445: CD Horizon Spinal System (2010), 581 descendants of its own
- K110070: TSRH Spinal System (2011), 269 descendants of its own
- K111457: CD Horizon Spinal System (2011), 261 descendants of its own
- K113395: Revere 4.5 Stabilization System (2012), 260 descendants of its own

## Indications for use
When labeled for pedicle screw fixation, the ISOLA implants are intended for use in grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral vertebral (L5-S1) joint utilizing autologous bone graft and intended to be removed after solid fusion is attained. The ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac 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 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/K962984
Methodology: https://510kreport.com/methodology