← Product Code [HBB](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB) · K962483 # MIDAS REX III MOTOR (K962483) _Midas Rex Pneumatic Tools, Inc. · HBB · Nov 19, 1996 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K962483 ## Device Facts - **Applicant:** Midas Rex Pneumatic Tools, Inc. - **Product Code:** [HBB](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB.md) - **Decision Date:** Nov 19, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.4370 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Indications for Use The Midas Rex Motor is designed for skull base and other microsurgical applications, including otolaryngology, ear, nose and throat, craniofacial and maxillofacial specifications in which a small, lightweight, high speed bone dissection system is desired. ## Device Story Pneumatic cranial drill motor; lightweight, ergonomic design; variable speed operation. Input: compressed air (20-150 psi). Output: high-speed mechanical bone dissection. Used in OR by surgeons for microsurgical applications. Integrates with existing Midas Rex GS dissecting tools, tube attachments, fixed/rotating footed attachments, telescoping microsystems, and micro mini drill guides. Facilitates precise bone removal in skull base and ENT procedures. ## Clinical Evidence Bench testing only; no clinical data provided. Substantial equivalence based on design and performance similarity to predicate devices. ## Technological Characteristics Pneumatic motor; operating pressure 20-150 psi (2-10 bar), recommended 100 psi (6.9 bar). Lightweight, small diameter housing. Quick disconnect interface for GS dissecting tools and attachments. Mechanical energy source. ## Regulatory Identification A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull. ## Predicate Devices - Midas Rex Motors, Midas (I, II, & Convertible) ([K953434](/device/K953434.md)) - Midas Rex Motors, Midas (I, II, & Convertible) ([K952300](/device/K952300.md)) - Whirl Wind TM (Pre-1976) - Midas GS and GS20 Surgical Tool System ([K952463](/device/K952463.md)) - Midas Drill Guide Attachment ([K954076](/device/K954076.md)) - Midas Telescoping System ([K953433](/device/K953433.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} NOV 19 1996 K962483 # 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS Date prepared: June 17, 1996 Submitter: Midas Rex Pneumatic Tools Inc. 3001 Race Street Fort Worth, Texas 76111 (817) 831-4181 Contact Person: Michael Fowler Director Regulatory Affairs Trade (proprietary) Name: Midas Rex Motor (Midas III) Common / Classification Name: Pneumatic Cranial Drill Motor Device Classification: Class II Predicate Device: Midas Rex Motors, Midas (I, II, & Convertible) K953434 Class II Midas (I, II, & Convertible) K952300 Class I Whirl Wind TM (Pre-1976) Predicate Attachments: Midas GS and GS20 Surgical Tool System K952463 Class I Midas Drill Guide Attachment K954076 Class I Midas Telescoping System K953433 Class I Premarket Notification: Midas Rex Pneumatic Tools Inc. Billmansafety {1} Premarket Notification: Midas Rex Pneumatic Tools. Cstansafety # Description Of the Device: Ergonomically, designed lightweight motor featuring small, overall diameter for comfort and ease of handling. The Midas Rex III motor operates at variable speeds. Operating pressures range from 20-150 psi (2-10 bar), with a suggested operating pressure of 100 psi (6.9 bar). The Midas Rex III has a standard quick disconnect GS dissecting tool and tube attachment system, which includes a fixed or rotating footed attachment, the telescoping microsystems, and the micro mini drill guide. # Statement of Intended Use: The Midas Rex Motor is designed for skull base and other microsurgical applications, including otolaryngology, ear, nose and throat, craniofacial and maxillofacial specifications in which a small, lightweight, high speed bone dissection system is desired. # Technological Characteristics: The modified device has the same technological characteristics (i.e., design, material, energy source) as the predicate device. The specifications are as follows: --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K962483](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBB/K962483) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com