BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED

K073615 · Brainlab AG · HAW · Sep 5, 2008 · Neurology

Device Facts

• Record ID: K073615
• Device Name: BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Sep 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Brainl AB/knee is intended to be an intraoperative image guided localization system to eBrainLAB/knee is intended to be an intraoperative image guided localization system to enable minimally/invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, x-ray, MR-based model of the anatomy. The system aids the surgeon to accurately navigate a knee prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by BrainLAB knee.

Device Story

BrainLAB knee is an intraoperative image-guided localization system for orthopedic surgery. It uses a freehand probe tracked by a passive marker sensor system to map anatomical landmarks on the patient's bone. The system generates a 3D model of the bone surface intraoperatively, eliminating the need for preoperative CT scans. The software reconstructs the mechanical axis and alignment of implants, allowing surgeons to navigate cutting guides and prostheses to planned positions. Used in clinical settings by surgeons, the system provides real-time visual feedback on a display, assisting in ligament balancing and bone alignment measurements. This guidance aims to improve the accuracy of implant placement and surgical outcomes.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Stereotaxic instrument; passive marker sensor system; freehand probe; 3D bone surface modeling via landmark acquisition; software-based 3D reconstruction of mechanical axis and implant alignment; non-CT-based registration.

Indications for Use

Indicated for patients undergoing orthopedic surgery, including total knee replacement, ligament balancing, range of motion analysis, and patella tracking, where stereotactic navigation relative to rigid anatomical structures (skull, long bone, vertebra) is appropriate.

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

• Vector Vision® CT-free Knee (K021306)
• Ci TKR/UKR (K052966)
• VectorVision uni-knee (K041899)

Submission Summary (Full Text)

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K073615

# 510 (k) Summary of Safety and Effectiveness for BrainLAB knee

| Manufacturer: | BrainLAB AG |
|-----------------|----------------------------------------------------|
| Address: | Kapellenstrasse 12<br>85622 Feldkirchen<br>Germany |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Mr. Per Persson |
| Summary Date: | December 5, 2007 |

SSEP-520008

| Device Name: | |
|-----------------------------|----------------------------------------------------------------------------------|
| Trade name: | BrainLAB knee essential, BrainLAB knee unlimited<br>Ci™ knee, Ci™ knee unlimited |
| Common/Classification Name: | BrainLAB Image Guided Surgery System / Instrument,<br>Stereotaxic |

Predicate Devices:
Vector Vision® CT-free Knee (K021306)
Ci TKR/UKR (K052966)
VectorVision uni-knee (K041899)

| Device Classification Name: | Instrument, Stereotaxic |
|-----------------------------|-------------------------|
| Regulatory Class: | Class II |

Intended Use:
Brainl AB/knee is intended to be an intraoperative image guided localization system to eBrainLAB/knee is intended to be an intraoperative image guided localization system to enable minimally/invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, x-ray, MR-based model of the anatomy. The system aids the surgeon to accurately navigate a knee prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by BrainLAB knee.

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Example orthopedic surgical procedures include but are not limited to:

- · Total Knee Replacement
- Smeenter Knee Replacement
- · Ligament Balancing
- · Range of Motion Analysis
- Cruciate Ligamoni Sargers
- · Patella Tracking

#### Device Description:

BrainLAB knee is intended to enable operational planning and/navigation in orthopedic surgery. It links a surqical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is gegerated through acquiring multiple landmarks on the bone surface. BrainLAB knee uses the registered landmarks to navigate the femoral and tibial cutting guides and the implant to the planned optimally position.

BrainLAB knee allows 3-dimensional reconstruction of the mechanical axis and alignment of the implants. BrainLAB knee software registers the, patient data needed for planning and navigating the surgery intraoperatively. No preoperative CT-scanning is necessary.

### Substantial equivalence:

BrainLAB knee has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the/safety and effectiveness of the information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with predicate devices such as the 510(k)-clearance of VectorVision® CT-free knee (K021306), VectorVision® Uni-Knee (K041899) and of Ci TKR/UKR (K052966).

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BrainLAB AG % Mr. Per Persson Kapellenstrasse 12 Feldkirchen Germany 85622

SEP - 5 2008

Re: K073615

Trade/Device Name: BrainLab knee Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: August 25, 2008 Received: September 2, 2008

Dear Mr. Persson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2 - Mr. Per Persson

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Mullean

Mark N. Melkerson 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

K073615 510(k) Number (if known):

Device Name: BrainLAB knee

Indications For Use:

BrainLAB knee is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, x-ray, MR-based model of the anatomy. The system aids the surgeon to accurately navigate a knee prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by BrainLAB knee.

Example orthopedic surgical procedures include but are not limited to:

- · Total Knee Replacement
- · Ligament Balancing
- Range of Motion Analysis
- · Patella Tracking

| Prescription Use<br>(Per 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
|------------------------------------------------|---|--------|------------------------------------------------|--|
|------------------------------------------------|---|--------|------------------------------------------------|--|

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | 16073618 |
|---------------|----------|
|---------------|----------|

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