# K980761: Synthes Spine Pediatric Rod System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine
- Decided: Aug 4, 1998 after 158 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 K962984 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962984: Isola Pediatric Components, Acromed Corp. (1996) Summary page 1.

## Most influential descendants
- K991552: Synthes Pediatric Rod System (1999), 0 descendants of its own

## Indications for use
When labeled for pedicle screw fixation, the Pediatric Rod System is intended for use in grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral vertebral joint (L5-S1) utilizing autologous bone graft and intended to be removed after solid fusion is attained. The SYNTHES Spine Pediatric Rod System is intended for pediatric patients with a body weight of 50lbs or less.

Source page: https://510kreport.com/device/K980761
Methodology: https://510kreport.com/methodology