# K071668: Orthobiom Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Paradigm Spine
- Decided: Jul 2, 2008 after 379 days
- Product code: MNI (Orthosis, Spinal Pedicle 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: 2 generations back to K953915 (1996). 7 ancestors in all.
582 later devices descend from it; 3 cite it directly.
1 of 590 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K781443: Harrington Spine Instrumentation, Orthopedic Equipment Co., Inc. (1978) Summary page 1.
- K994121: Small Stature Uss, Synthes (Usa) (2000) Summary page 1.
- K974757: Kaneda Anterior Scoliosis System Kass, Acromed Corp. (1998) Summary page 1.
- K962984: Isola Pediatric Components, Acromed Corp. (1996) Summary page 1.
- K012916: Frontier Anterior Scoliosis System, Depuy Acromed, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K113666: Xia 3 Spinal System (2012), 251 descendants of its own

## Indications for use
The OrthobiomTM Spinal System is a posterior, non-cervical pedicle screw system indicated to treat pediatric scoliosis by (1) correction, (2) stabilization, (3) adjustment and (4) fixation of the scoliotic spine. The Orthobiom TM Spinal System is intended to be used with bone graft.

Source page: https://510kreport.com/device/K071668
Methodology: https://510kreport.com/methodology