← Product Code [HWE](/submissions/SU/subpart-e%E2%80%94surgical-devices/HWE) · K973736

# AESCULAP HILAN MOTOR SYSTEM (K973736)

_Aesculap, Inc. · HWE · Dec 29, 1997 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWE/K973736

## Device Facts

- **Applicant:** Aesculap, Inc.
- **Product Code:** [HWE](/submissions/SU/subpart-e%E2%80%94surgical-devices/HWE.md)
- **Decision Date:** Dec 29, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4820
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Intended Use

Aesculap's HiLan Motor System is a high-speed pneumatic motor system intended for use in surgical procedures to drive handpieces which cut and shape bone. It is indicated for use in orthopedics, spine, and plastic/reconstructive (i.e. maxillofacial and craniofacial) procedures.

## Device Story

The HiLan Pneumatic Motor System is a high-speed surgical tool used to drive handpieces for cutting and shaping bone. The system comprises a handheld pneumatic motor, air hose, foot control, and various handpieces connected via a proprietary coupling system. It is intended for use by surgeons in orthopedic, spine, and plastic/reconstructive procedures. The device functions by converting pneumatic energy into mechanical rotation to power surgical attachments. It is used in clinical surgical settings to assist in bone manipulation, potentially improving procedural efficiency and precision during surgery.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Pneumatic motor system; proprietary coupling system for handpieces; handheld form factor; manufactured in accordance with ISO and German DIN standards; ISO 9001 certified facility.

## Regulatory Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

## Predicate Devices

- Anspach high-speed pneumatic systems
- Hall/Zimmer high-speed pneumatic systems
- Midas Rex high-speed pneumatic systems
- Zepplin high-speed pneumatic systems

## Submission Summary (Full Text)

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510(k) Summary of Safety and Effectivencss in Accordance with SMDA of 1990 Aesculap HiLan Motor System

December 23, 1997

K973736

Aesculap®, Inc. Submilted by: 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Mary Ellen Holden Phone: (650) 876-7000 x348 FAX: (650) 589-3007

> Product: Aesculab Hillan Motor System Common Name: Pneumatic Motor System

#### Device Description

The Hillan Pneumatic Motor System consists of a small hand held motor, an air hose, a foot control, a pneumatic motor hose, and various handpieces. The system components connect to each other via a proprietary coupling system.

#### Intended Use

Aesculap's HiLan Motor System is a high-speed pneumatic motor system intended for use in surgical procedures to drive handpieces which cut and shape bone. It is indicated for use in orthopedics, spine, and plastic/reconstructive (i.e. maxillofacial and craniofacial) procedures.

### Technological Characteristics

The I liLan Motor System is an extension to Aesculap's Pneumatic Motor System product line. The HiLan's primary difference is the speed of the motor. The speed of the motor is substantially equivalent to high-speed pneumatic systems by Anspach, Hall/Zimmer, Midas Rex and Zepplin.

#### Porformance Standards

No applicable performance standards have been promulyated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However. Aesculan's Hil an Motor System is manufactured in accordance with ISO and German DIn Standards. Furthermore, Aesculap AG has received ISO 9001 certification.

#### Substantial Equivalence

Aesculap's HiLan Motor System shares similar features and function with corresponding devices distributed by Aesculap, Anspach, Hall/Zimmer, Midas Rex and Zepplin.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary E. Holden Regulatory Associate Aesculap, Incorporated 1000 Gateway Boulevard South San Francisco, California 94080-7030

DEC 2 9 1997

Re: K973736 Trade Name: Aesculap Hilan Motor System Regulatory Class: I Product Code: HWE Dated: September 30, 1997 Received: October 1, 1997

Dear Ms. Holden:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for

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Page 2 - Ms. Holden

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATION FOR USE STATEMENT

510(k) Number (if known): K973736

Device Name:

Aesculap HiLan Motor System

## Indication for Use:

Aesculap's HilLan Motor System is a high-speed pneumatic motor system intended for use in surgical procedures to drive handpieces which cut and shape bone. It is indicated for use in orthopedics, spine, and plastic/reconstructive (i.e. maxillofacial and craniofacial) procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number R 9737

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