MySpine Pedicle Screw Placement Guides - LP

K153273 · Medacta International S.A. · MNI · Jun 29, 2016 · Orthopedic

Device Facts

• Record ID: K153273
• Device Name: MySpine Pedicle Screw Placement Guides - LP
• Applicant: Medacta International S.A.
• Product Code: MNI · Orthopedic
• Decision Date: Jun 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

MySpine is intended as a thoracic and lumbar posterior guide for patients requiring spinal fusion between the levels of T1 to L5. MySpine Screw Placement Guides are intended to be used as anatomical perforating guides specific for a single patient anatomy to assist intraoperatively in the positioning of Pedicle screws in the vertebral body. MySpine is intended for use with M.U.S.T. Pedicle Screw System and its cleared indications for use. MySpine Low Profile screw placement guides are intended for the placement of K-wires to assist in the positioning of pedicle screws. Use of the guides involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipment components. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine Screw placement guides are intended for single use only.

Device Story

Patient-specific surgical guides; fabricated from patient CT scans via preoperative planning software. Guides provide anatomical reference for intraoperative K-wire placement; facilitating subsequent insertion of cannulated pedicle screws. Used in thoracic/lumbar spinal fusion procedures; operated by surgeons. System replaces traditional manual pedicle preparation with patient-matched geometry to improve screw positioning accuracy. Guides are single-use; removed after K-wire placement. Benefits include precise implant alignment per preoperative plan.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including sterilization validation (ANSI/AAMI/ISO 11137-1/2), packaging validation (ANSI/AAMI/ISO 11607), biocompatibility (ISO 10993-1), mechanical testing, and cadaver testing.

Technological Characteristics

Materials: PA12 Medical Grade. Form factor: Patient-specific anatomical guides. Connectivity: Standalone software for preoperative planning. Sterilization: Provided sterile and non-sterile. Principle: Mechanical anatomical referencing for surgical instrument guidance.

Indications for Use

Indicated for patients requiring spinal fusion between T1 and L5 levels. Used as patient-specific anatomical guides to assist intraoperative positioning of pedicle screws or K-wires for cannulated implant placement. Intended for use with M.U.S.T. Pedicle Screw System.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• MySpine Pedicle Screw Placement Guides (K132788)

Submission Summary (Full Text)

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

June 29, 2016

Medacta International SA % Roshana Ahmed, MA, RAC Senior Manager, Regulatory Affairs - Medical Devices Mapi USA, Incorporated 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504

Re: K153273

Trade/Device Name: MySpine Pedicle Screw Placement Guides - LP Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI Dated: June 1, 2016 Received: June 1, 2016

Dear Ms. Ahmed:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Mark N. Melkerson -S

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

Enclosure

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## Indications for Use

510(k) Number (if known) K153273

Device Name

MySpine Pedicle Screw Placement Guides - LP

#### Indications for Use (Describe)

MySpine is intended as a thoracic and lumbar posterior guide for patients requiring spinal fusion between the levels of T1 to L5.

MySpine Screw Placement Guides are intended to be used as anatomical perforating guides specific for a single patient anatomy to assist intraoperatively in the positioning of Pedicle screws in the vertebral body. MySpine is intended for use with M.U.S.T. Pedicle Screw System and its cleared indications for use.

MySpine Low Profile screw placement guides are intended for the placement of K-wires to assist in the positioning of pedicle screws.

Use of the guides involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipment components. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan.

MySpine Screw placement guides are intended for single use only.

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

| Applicant/Sponsor: | Medacta International SA |
|--------------------|-----------------------------|
| | Strada Regina |
| | 6874 Castel San Pietro (CH) |
| | Switzerland |
| | Phone [phone] |
| | Fax [phone] |
| Contact Person: | Stefano Baj |
| | Regulatory Affairs Manager |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |

Date Prepared: June 27, 2016

## DEVICE INFORMATION

| Trade/Proprietary Name: | MySpine Pedicle Screw Placement Guides - LP |
|--------------------------|---------------------------------------------|
| Common or Usual<br>Name: | Pedicle Screw Placement Guide |
| Classification Name: | Pedicle Screw Spinal System |
| Product Code: | MNI |
| Regulation Number: | 21 CFR 888.3070 |
| Device Class: | II |

## PREDICATE DEVICE INFORMATION

MySpine Pedicle Screw Placement Guides, K132788, Medacta International SA

## DEVICE DESCRIPTION

MySpine Pedicle Screw Placement Guides - LP are a design modification to MySpine Pedicle Screw Placement Guides (K132788). MySpine Pedicle Screw Placement Guides are patient specific surgical instruments that allow for guided K-wire placement. The MySpine software platform allows the surgeon to complete the preoperative planning in 3D based on the patient's spinal CT scans. Then, the K-wire is guided through the patient's anatomically matched MySpine LP Guides in order to provide positioning according to the surgeon's preoperative planning.

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For the standard guides introduced and cleared by FDA in K132788, the holes guide the instruments used to open and prepare the pedicle to the planned entry point. After pedicle preparation, the pedicle screws will be inserted through the guiding hole into the pedicle and the vertebrae respectively. For the LP guides introduced with this 510(k), the guiding holes allow placement of the K-wire. Then, the MySpine guide is removed and the wires are used to insert cannulated implants. As an intermediate step, the surgeon can also use the cannulated awl and/or tap to better prepare the entry point in order to simplify the screw tightening.

The components of the MySpine Pedicle Screw Placement Guides - LP include a Drill Guide (PA12 Medical Grade) and Vertebral Bone Models (PA12 Medical Grade). The MySpine Pedicle Screw Placement Guides – LP are single use, external communicating devices with limited (<24 hours) contact duration and are provided in sterile and nonsterile versions.

## INDICATIONS FOR USE

MySpine is intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of T1 to L5.

MySpine Screw Placement Guides are intended to be used as anatomical perforating guides specific for a single patient anatomy to assist intraoperatively in the positioning of Pedicle screws in the vertebral body. MySpine is intended for use with M.U.S.T. Pedicle Screw System and its cleared indications for use.

MySpine Low Profile screw placement guides are intended for the placement of K-wires to assist in the positioning of pedicle screws.

Use of the guides involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipment components. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan.

MySpine Screw placement guides are intended for single use only.

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The materials of the MySpine Pedicle Screw Placement Guides - LP are identical to the previously cleared predicate device. The design features, geometries, and sizes of the subject devices are substantially equivalent to those of the predicate device. The fundamental scientific technology of the modified devices has not changed relative to the predicate device. The safety and effectiveness of the MySpine Screw Placement Guides - LP are adequately

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supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

# PERFORMANCE TESTING

The following testing was leveraged or conducted to support substantial equivalence:

- Sterilization validation in accordance with ANSI/AAMI/ISO 11137-1 and -2 ●
- . Packaging validation in accordance with ANSI/AAMI/ISO 11607
- Biocompatibility in accordance with ISO 10993-1 .
- Mechanical testing ●
- Cadaver testing ●

# CONCLUSION:

Based on the above information, the MySpine Pedicle Screw Placement Guides – LP are substantially equivalent to the predicate devices.