AESCULAP ORTHOPILOT 2 THA V 2.0

K050752 · Aesculap, Inc. · HAW · Apr 27, 2005 · Neurology

Device Facts

• Record ID: K050752
• Device Name: AESCULAP ORTHOPILOT 2 THA V 2.0
• Applicant: Aesculap, Inc.
• Product Code: HAW · Neurology
• Decision Date: Apr 27, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Orthopilot® 2 Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to optimally position endoprosities in arthroplasty such as the Search Evolution Knee system and the Gem Knee system in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for total endoprosthesis replacement surgery and provides intraoperative measurements of bone alignment. It indicates optimized angles and positions for implant placement.

Device Story

Orthopilot 2 Navigation Platform is a computer-aided surgical navigation system used in orthopedic arthroplasty. System utilizes a camera to track the spatial relationship between patient anatomy and surgical instruments via markers mounted to bones or mobile probes. Software processes spatial data to provide real-time navigation, indicating optimized angles and positions for implant placement and bone alignment. Used in the operating room by surgeons to guide cutting, drilling, and reaming during total endoprosthesis replacement. Output is displayed to the surgeon to assist in accurate instrument positioning and implant alignment, potentially improving surgical precision and patient outcomes.

Clinical Evidence

Bench testing only. The device was developed and validated in accordance with internal SOPs and the FDA's 'General Principles of Software Validation'. Compliance with IEC 60601-1 (General Requirements for Safety) and IEC 60601-1-2 (Electromagnetic Compatibility) was confirmed.

Technological Characteristics

Surgical navigation platform consisting of a camera-based tracking system and software module. Operates via spatial tracking of markers mounted to patient anatomy or instruments. Complies with IEC 60601-1 and IEC 60601-1-2 standards. Software-based navigation system.

Indications for Use

Indicated for patients undergoing total endoprosthesis replacement surgery (arthroplasty), specifically for use with the Search Evolution Knee system and the Gem Knee system. Aids surgeons in positioning surgical instruments, cutting guides, drills, and reamers, and provides intraoperative bone alignment measurements.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• Aesculap Orthopilot 2 THA Module V 1 (K013569)

Submission Summary (Full Text)

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# B. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

(in Accordance with SMDA of 1990)

#### Aesculap Orthopilot 2 THA V 2.0.4 23 March 2005

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
|-----------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Matthew M. Hull<br>800-258-1946 x 5072 (phone)<br>610-791-6882 (fax) |
| TRADE NAME: | Aesculap Orthopilot 2 THA V 2.0 |
| COMMON NAME: | Surgical Navigation Platform |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 84 HAW |
| CLASSIFICATION: | 882.4560 - Stereotaxic Instrument |
| REVIEW PANEL: | Neurology |

# INDICATIONS FOR USE

The Orthopilot® 2 Navigation Platform is a system for computer-aided navigation of surgical The Orthopilor 2 Navigation Plation is a sition endoprosthesis in arthroplasty such as the Institution Knee system and the Gem Knee system in the patient. It aids the surgeon Search Evolution Rhee System and the cutting guides, drills and reamers for total endoprosthesis In accurately positioning the oating grative measurements of bone alignment. It indicates optimized angles and positions for implant placement.

# DEVICE DESCRIPTION

The Total Hip Arthroplasty (THA) software module version 2.0 is an upgrade to the THA The Total Thp Arthopidocy ( . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . version 1 that was Onginally of are and hip arthroplasty using Aesculap's Orthopilot 2 provide computer alocu namagation for sear. that are mounted to the patients bones, or plation. The Orthopliot 2 dood transmation with a camera to monitor the are mobile to palpato anatomitters in relation to each other and/or instruments.

#### PERFORMANCE DATA

No applicable performance standards have been promulgated under FDCA Section 514 No applicable performance was developed in accordance with Aesculap's internal SOP's as well as CDRH's "General Principles of Software Validation; Final internal SOF 3 as well as OBR. For Control of Navigation platform does comply with the following FDA recognized standards:

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Special 510(k) Premarket Notification

K0507S2

- International Electrotechnical Commission; Medical Electrical IEC 60601-1 Equipment, Part 1: General Requirements for Safety.
- International Electrotechnical Commission; Medical Electrical IEC 60601-1-2 Equipment, General Requirements for Safety: Electromagnetic Compatibility - Requirements and Tests.

# SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Orthopilot 2 THA Software Module 2.0 is substantially Aesculap ', inc. bellovoo that the Od THA Module 1 that was cleared in Aesculap's 510(k) submission #K013569 for Orthopilot 2.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

APR 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mathew M. Hull, RAC Regulatory Affairs Manager Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K050752

R050752
Trade/Device Name: Aesculap Orthopilot 2 THA Module V 2.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 21, 2005 Received: April 22, 2005

Dear Mr.Hull:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becaon - ro(x) presidentially equivalent (for the indications felerenced above and nave decembled we are and for use stated in the encrosule) to legally manative province to of the Medical Device Amendments, or to commerce prior to May 26, 1976, the enature with the provisions of the Federal Food, Drug. devices that have been recalised in accerative in a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket af the Agt, if th and Cosmetic Act (Act) that do not require appro the general controls provisions of the Act. The You may, therefore, market the devices, seejes of the counter for annual registration, listing of general controls provisions of the Fiel labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) into e. Existins major regulations affecting your device .
it may be subject to such additional controls. Existing major Leveldition it may be subject to such additional controls: "Bheilege":"
can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 minutes and can be found in the Code of I caeral cognition in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination mot of the other Please be advised that IDA s issualice of a became of the requirements of the Act
that FDA has made a determination that your device complies with other mast that FDA has made a determination administered by other Federal agencies. You must or any Federal Statutes and regulations and ing, but not limited to: registration and listing (21 let comply with an the Act 3 requirements, and manufacturing practice requirements as set Cr K Part 807), labeling (21 CFR Part 800), go a art 820); and if applicable, the electronic forth in the quality systems (QD) regalates (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Mathew M. Hull, RAC

This letter will allow you to begin marketing your device as described in your Section 5 10(k)
10 leval This letter will allow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, premarket notification. The PDA Inding of Substantal of a many of the spermits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the regulation and 10, 2011 for Alex also as and the regulation entitled If you desire specific advice for your de not our our our our note the regulation entitled, the leavers of the regulation contact the Office of Collipialice at (246) 270 - 1 (2107R Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 the African of Small "Misbranding by relerence to premarket notification of Set from the Division of Small
other general information on your responsibilities under the tall, from pumber (800) 638 other general information on your responsion.com its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-freevertry/support/in Manufacturers, International and Consulter Assistance at to voor virus virus virus variantes. html.

Sincerely yours,

signature

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE STATEMENT B.

14050752 510(k) Number:________________________________________________________________________________________________________________________________________________________________

# Device Name: Aesculap Orthopilot 2 THA Module V 2.0

### Indication for Use:

The Orthopilot® 2 Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to optimally position endoprosities in arthroplasty such as the Search Evolution Knee system and the Gem Knee system in the patient. It aids the surgeon Search Evolution Knee system and the Och I the Present of Criter belopment of in accurately positioning the cutting guides intraoperative of bone alignment. It replacement "surgery" and promotions for implant placement.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

050752

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