SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS

K122211 · Synthes Spine · HAW · Dec 17, 2012 · Neurology

Device Facts

• Record ID: K122211
• Device Name: SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS
• Applicant: Synthes Spine
• Product Code: HAW · Neurology
• Decision Date: Dec 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Synthes Navigable Pedicle Preparation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion.

Device Story

Manual surgical instruments designed to interface with cleared surgical navigation systems; used in open, minimally invasive, or percutaneous spinal procedures. Instruments may be pre-calibrated or manually calibrated to navigation systems. Surgeon uses instruments to precisely locate anatomical structures (pelvis/vertebrae) relative to pre-acquired or intraoperative image data (CT, MR, 2D/3D fluoroscopy). Output is physical guidance for pedicle preparation; assists surgeon in navigation-guided spinal surgery. Benefits include improved precision in locating anatomy during spinal fusion or other spinal procedures.

Clinical Evidence

No clinical data. Validation performed via bench testing and usability testing to confirm performance requirements.

Technological Characteristics

Manual surgical instruments; designed to interface with cleared surgical navigation systems. Materials and design features are consistent with predicate stereotaxic instruments. No energy source; standalone mechanical devices.

Indications for Use

Indicated for patients undergoing surgical spinal procedures, including spinal fusion, where stereotactic navigation is appropriate and rigid anatomical structures (pelvis/vertebrae) can be referenced against CT, MR, or fluoroscopic image data.

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

• BrainLab VectorVision Fluoro3D System (K070106)
• Medtronic StealthStation (K050438)
• Stryker SpineMap (K003111)

Submission Summary (Full Text)

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122211

@ SYMTHES® Spine

DEC 1 7 2012

### 5 510(k) Summary

| 510(k) Summary | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Firm: | DePuy Synthes Spine<br>1302 Wrights Lane East<br>West Chester, PA 19380 |
| 510(k) Contact: | Hemal Mehta<br>Regulatory Affairs Specialist<br>Telephone: [phone]<br>Facsimile: 610-719-5102<br>Email: [e-mail] |
| Date Prepared: | December 14, 2012 |
| Trade Name: | Synthes Navigable Pedicle Preparation Instruments |
| Classification: | Sec. 882.4560<br>Class II<br>Orthopaedic<br>Product Code: OLO, HAW |
| Predicate<br>Devices: | K070106 BrainLab VectorVision Fluoro3D System<br>K050438 Medtronic StealthStation<br>K003111 Stryker SpineMap |
| Device<br>Description: | The Navigable Pedicle Preparation Instruments are manual surgical<br>instruments which are designed to interface with already-cleared surgical<br>navigation systems. Instruments in this system may be pre-calibrated to<br>already-cleared surgical navigation systems, or may be manually<br>calibrated to already-cleared surgical navigation systems using<br>manufacturers' instructions. These instruments are intended to be used in<br>spine applications to perform general manual functions within the<br>orthopaedic surgical environment. |
| Intended Use/<br>Indications for<br>Use: | The Synthes Navigable Pedicle Preparation Instruments are intended to<br>assist the surgeon in precisely locating anatomical structures in either<br>open, minimally invasive, or percutaneous procedures. These are<br>indicated for use in surgical spinal procedures, in which the use of<br>stereotactic surgery may be appropriate, and where reference to a rigid<br>anatomical structure, such as the pelvis or a vertebra can be identified<br>relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D<br>fluoroscopic image reconstruction) and/or an image data based model of<br>the anatomy. These procedures include but are not limited to spinal<br>fusion. |

P. 1/2

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| ® SYNTHES® | |
|------------|--|
| Spine | |

| 510(k) Summary<br>Comparison of<br>the device to<br>predicate<br>device(s): | The design features, materials, and indications for use of the subject<br>Synthes Navigable Pedicle Preparation Instruments are substantially<br>equivalent to the predicate devices identified. |
|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Data<br>(Non-Clinical<br>and/or Clinical): | Synthes conducted validation activities including usability testing. The<br>Navigable Pedicle Preparation Instruments met the performance<br>requirements, providing assurance of device performance for their<br>intended use. No safety or effectiveness issues were raised by the<br>performance testing. Clinical data was not needed for the Navigable<br>Pedicle Preparation Instruments. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 17, 2012

Synthes Spine % Mr. Hemal Mehta Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K122211

Trade/Device Name: Synthes Navigable Pedicle Preparation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OLO, HAW Dated: October 23, 2012 Received: October 24, 2012

Dear Ms. Guerin:

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 - Ms. Heather Guerin

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/industry/support/index.html.

Sincerely yours,

# Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

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@ SYNTHES® Spine

#### Indications for Use Statement 4

K122211 510(k) Number: (if known)

Synthes Navigable Pedicle Preparation Instruments Device Name:

Indications for Use:

The Synthes Navigable Pedicle Preparation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion.

X Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

[2017-12-09] 14:23:06 -05'00'

(Division Sign-off) Division of Surgical Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________ K122211