# K012129: Ortho Development Orion-I Emf System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Aug 22, 2001 after 44 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K943450 (1995). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001986: Surgitron Iec II, Ellman Intl., Inc. (2000) Summary page 1.
- K001407: Surgitron Iec II, Ellman Intl., Inc. (2000) Summary page 1.
- K001588: Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000 Footswitch, Arthrocare System 20, Arthrocare Corp. (2000) Summary page 1.
- K992581: Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands, Arthrowands, Arthrocare Corp. (1999) Summary page 1.
- K982176: Kirwan Surgical Products, Inc. Model 28 1500 Electrosurgery Generator, Kirwan Surgical Products, Inc. (1998) Summary page 1.

## Indications for use
The ORION-I EMF System is intended to be used for general surgical purposes in coagulation, cutting and ablation of soft tissues, including but not limited to orthopedic, arthroscopic, spinal, and neurosurgical procedures. Arthroscopic procedures may include those on the shoulder, elbow, wrist, hip, knee, and ankle. The ORION-| EMF System is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Source page: https://510kreport.com/device/K012129
Methodology: https://510kreport.com/methodology