# K781443: Harrington Spine Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Orthopedic Equipment Co., Inc.
- Decided: Sep 27, 1978 after 35 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.
583 later devices descend from it; 2 cite it directly.
1 of 584 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K781443
Methodology: https://510kreport.com/methodology