Cleared Traditional

K012129 - ORTHO DEVELOPMENT ORION-I EMF SYSTEM

K012129 is an FDA 510(k) clearance for ORTHO DEVELOPMENT ORION-I EMF SYSTEM, manufactured by Ortho Development Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K012129 · Ortho Development Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
44d
Days
Class 2
Risk

K012129 is an FDA 510(k) clearance for the ORTHO DEVELOPMENT ORION-I EMF SYSTEM. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on August 22, 2001 after a review of 44 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ortho Development Corp. devices

FDA 510(k) Submission Details - K012129

510(k) Number K012129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2001
Decision Date August 22, 2001
Days to Decision 44 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 115d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Underwriters Laboratories, Inc.
MICHAEL KWAN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1747
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K012129.
ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL
K012799 · Senorx, Inc. · Sep 2001
ATRICURE BIPOLAR COAGULATION SYSTEM
K011722 · AtriCure, Inc. · Aug 2001
MODIFICATION TO:ENDIUS BIPOLAR SHEATH
K012488 · Endius, Inc. · Aug 2001
ENTEC EVAC PLASMA WAND
K011279 · Arthrocare Corp. · Jul 2001
ARTHROCARE CONTROLLER, MODEL H2000
K011634 · Arthrocare Corp. · Jun 2001
DENSTAT
K010465 · Elmed, Inc. · May 2001

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.