BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS

K060121 · Biomet Manufacturing Corp · HAW · Mar 21, 2006 · Neurology

Device Facts

• Record ID: K060121
• Device Name: BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS
• Applicant: Biomet Manufacturing Corp
• Product Code: HAW · Neurology
• Decision Date: Mar 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are intended to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are indicated for use in surgical hip procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure such as long bone can be identified relative to a CT based model or by an individual 3D model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. These procedures include but are not limited to acetabular cup replacement as part of a partial or total hip arthroplasty (primary or revision).

Device Story

Reusable manual orthopedic surgical instruments modified with navigation adapters; designed for use with BrainLAB VectorVision Hip Image Guided Surgery System. Instruments assist surgeons in OR to precisely locate anatomical structures during open or percutaneous hip procedures. System uses CT-based models or patient-specific 3D bone models generated from surface landmarks to provide navigation. Surgeon uses visual output from navigation system to guide instrument placement; facilitates accurate acetabular cup positioning. Benefits include improved surgical precision in hip arthroplasty.

Clinical Evidence

No clinical data provided. Substantial equivalence based on non-clinical laboratory testing demonstrating device functionality.

Technological Characteristics

Reusable manual orthopedic instruments; modified with navigation adapters for integration with BrainLAB VectorVision Hip Image Guided Surgery System. System utilizes stereotactic navigation principles. Connectivity is via integration with the BrainLAB platform.

Indications for Use

Indicated for patients undergoing surgical hip procedures, including primary or revision partial or total hip arthroplasty, where stereotactic surgery is appropriate and rigid anatomical structures (long bones) can be referenced via CT-based or surface-landmark-generated 3D models.

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

• Smith & Nephew Image-Guided Instruments for Hip Applications (K033341)
• BrainLAB VectorVision® Hip 3.0 Image Guided Surgery System (K040368)
• DePuy CAS Hip Instrumentation (K052178)
• BrainLAB VectorVision® Hip Software on the Ci platform (K052213)

Submission Summary (Full Text)

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## 510(k) Summarv

| Applicant/Sponsor: | Biomet Manufacturing Corp.<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587 |
|----------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Lester F. Padilla |
| Proprietary Name: | Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip<br>Applications |
| Common Name: | Stereotaxic Instrument |
| Classification Name: | Instrument, Stereotaxic (21 CFR 888.4560) |

## Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

- Smith & Nephew Image-Guided Instruments for Hip Applications (K033341) 1.
- BrainLAB VectorVision® Hip 3.0 Image Guided Surgery System (K040368) 2.
- DePuy CAS Hip Instrumentation (K052178) 3.
- BrainLAB VectorVision® Hip Software on the Ci platform (K052213) ক

Device Description: The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are reusable conventional manual orthopedic surgical instruments modified with a navigation adapter for use with the BrainLAB VectorVision® Hip Image Guided Surgery System.

Intended Use: The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are intended to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Biomet Pre-Calibrated Surgical Navigation Instruments for Hip Applications are indicated for use in surgical hip procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure such as long bone can be identified relative to a CT based model or by an individual 3D model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. These procedures include but are not limited to acetabular cup replacement as part of a partial or total hip arthroplasty (primary or revision).

Summary of Technologies: The Pre-Calibrated Surgical Navigation Instruments for Hip Applications and the predicate devices all have similar technological characteristics.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

Prepared: January 4, 2006

All trademarks are property of Biomet, Inc. except for Vector Vision, which is a trademark of BrainLAB AG. Germany

| MAILING ADDRESS | P.O. Box 587 |
|------------------|-----------------------|
| | Warsaw, IN 46581 0587 |
| SHIPPING ADDRESS | 56 E. Bell Drive |
| | Warsaw, IN 46582 |
| OFFICE | 574.267.6639 |
| FAX | 574.267.8157 |
| E-MAIL | [e-mail] |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2006

Biomet Manufacturing Corporation c/o Mr. Lester F. Padilla Regulatory Affairs Associate P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K060121

Trade/Device Name: Biomct Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications Regulation Number: 21 CFR 882.4560

Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 13, 2006 Received: January 17, 2006

Dear Mr. Padilla:

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 docs 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

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Page 2 – Mr. Lester F. Padilla

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. 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

dlqme

Mark N. Melkerson 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

510(k) Number (if known): KO6012)

Device Name: Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications

Indications For Use:

The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are intended to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are indicated for use in surgical hip procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure such as long bone can be identified relative to a CT based model or by an individual 3D model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. These procedures include but are not limited to acetabular cup replacement as part of a partial or total hip arthroplasty (primary or revision).

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR AND/OR AND/OR AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/OR AND/ORD AN

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

emaee

(Division Sign Off) Division of General, Restorative. and Neurological Devices

510(k) Number_KOSOL2 1

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