# K981113: Pediatric PRC

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: May 29, 1998 after 63 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 K920392 (1992). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920392: Isola Spine System: Plate-Rod Combination, Acromed Corp. (1992) Summary page 2.
- K952236: Isola System, Acromed Corp. (1996) Summary page 2.
- K962984: Isola Pediatric Components, Acromed Corp. (1996) Summary page 2.

## Most influential descendants
- K191212: CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System (2019), 0 descendants of its own

## Indications for use
The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at LS-S1 utilizing autologous bone graft, when affixed to the lumbosacral spine, 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 fusion. As 8 whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-S1.

Source page: https://510kreport.com/device/K981113
Methodology: https://510kreport.com/methodology