510(k) · Cleared

Cleared

Ortho Development Orion-I Emf System

K012129510(k) TraditionalCleared Aug 22, 200144-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ortho Development Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Aug 22, 2001 as substantially equivalent to K001986 (Ellman Intl., Inc., 2000) and 4 other predicates after a 44-day review. Its family tree reaches back 6 generations to 1995.

Decided: Aug 22, 2001
Review: 44 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 5

Its longest line of descent runs back 6 generations to K943450 (1995). 21 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.

By dateBy generation

Root · 6 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
5 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
4 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
3 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
2 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
1 generation backK992581 Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord…Arthrocare Corp. · 1999
This deviceK012129 Ortho Development Orion-I Emf SystemOrtho Development Corp. · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K943450	Arthrocare Arthroscopic Electrosurgery System Model 970	Arthrocare Corp.	1995	—
−5	K961069	Arthrocare Urologic Multi-Electrode Electrosurgery System	Arthrocare Corp.	1996	—
−4	K962445	Arthrocare Dental Electrosurgery System	Arthrocare Corp.	1996	—
−3	K964849	Arthrocare Dermatologic Electrosurgery System	Arthrocare Corp.	1997	—
−2	K973478	Arthrocare Sinus Electrosurgery System	Arthrocare Corp.	1998	—
−1	K992581	Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands…	Arthrocare Corp.	1999	—
0 (this device)	K012129	Ortho Development Orion-I Emf System	Ortho Development Corp.	2001	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	1	0
1992	2	0
1994	1	0
1995	2	0
1996	4	0
1998	2	0
2000	3	0

FIG. 1 — Lineage of K012129, 1995–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEI device

#1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K001986	Surgitron Iec II Summary page 1 …rgical generator and accessories Classification Name: Electrosurgical and Coagulation Unit and Accessories C. Predicate Devices: e Eliman Surgitron IEC \|l RF generator K001986, K001407 e ArthroCare System 2000 RF generator K001588, K992581 e Eliman Surgitron Hand-pieces K001986 « Kirwan Surgical Hand-pi…	Ellman Intl., Inc.	2000	—
*	K001407	Surgitron Iec II Summary page 1 …nerator and accessories Classification Name: Electrosurgical and Coagulation Unit and Accessories C. Predicate Devices: e Eliman Surgitron IEC \|l RF generator K001986, K001407 e ArthroCare System 2000 RF generator K001588, K992581 e Eliman Surgitron Hand-pieces K001986 « Kirwan Surgical Hand-pieces K982…	Ellman Intl., Inc.	2000	—
*	K001588	Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000… Summary page 1 …ectrosurgical and Coagulation Unit and Accessories C. Predicate Devices: e Eliman Surgitron IEC \|l RF generator K001986, K001407 e ArthroCare System 2000 RF generator K001588, K992581 e Eliman Surgitron Hand-pieces K001986 « Kirwan Surgical Hand-pieces K982176 ¢ Kirwan Surgical Electrodes K982176 D. De…	Arthrocare Corp.	2000	—
*	K992581	Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands… Summary page 1 …ical and Coagulation Unit and Accessories C. Predicate Devices: e Eliman Surgitron IEC \|l RF generator K001986, K001407 e ArthroCare System 2000 RF generator K001588, K992581 e Eliman Surgitron Hand-pieces K001986 « Kirwan Surgical Hand-pieces K982176 ¢ Kirwan Surgical Electrodes K982176 D. Device Desc…	Arthrocare Corp.	1999	—
*	K982176	Kirwan Surgical Products, Inc. Model 28 1500 Electrosurgery Generator Summary page 1 …gitron IEC \|l RF generator K001986, K001407 e ArthroCare System 2000 RF generator K001588, K992581 e Eliman Surgitron Hand-pieces K001986 « Kirwan Surgical Hand-pieces K982176 ¢ Kirwan Surgical Electrodes K982176 D. Device Description: The Ortho Development ORION-I EMF System is comprised of the ORION-I…	Kirwan Surgical Products, Inc.	1998	—

Also cleared against K001986: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
1 of the 21 ancestors has a recall of any class.
1 other device also cites its predicate K001986.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012129 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012129: Ortho Development Orion-I Emf System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012129

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026