ENNOVATE Spinal System

K162134 · Aesculap Implant Systems, LLC · NKB · Dec 14, 2016 · Orthopedic

Device Facts

• Record ID: K162134
• Device Name: ENNOVATE Spinal System
• Applicant: Aesculap Implant Systems, LLC
• Product Code: NKB · Orthopedic
• Decision Date: Dec 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities. 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). 2. Spondylolisthesis, 3. Trauma (i.e., fracture or dislocation) 4. Spinal Stenosis. 5. Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis), 6. Tumor. 7. Pseudoarthrosis, and 8. Failed previous fusion

Device Story

ENNOVATE Spinal System is a pedicle screw and rod implant system for thoracic, lumbar, and sacral spine stabilization. System comprises polyaxial screws, rods, and connectors; components are top-loading and top-tightening. Used by surgeons in open or minimally invasive (MIS) procedures to correct spinal deformity and facilitate fusion. Rods are shaped intraoperatively to match patient anatomy; screws are locked into configurations to provide rigid fixation. Device provides mechanical support to the spine, allowing biological fusion to occur; benefits include stabilization of unstable segments and correction of spinal curvature.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included dynamic/static compression and torsion tests (ASTM F1717-15), dynamic compression/tension (ASTM F2193-14), dynamic/static flexion bending, rod grip, and rod/cross rod torsion (ASTM F1798-13), and axial compression, pull-out strength, and driving torque (ASTM F543-13).

Technological Characteristics

Implants manufactured from titanium alloy (Ti-6Al-4V) per ISO 5832-3. Instruments made of medical grade silicone, stainless steel, titanium alloy, and PEEK. System features polyaxial screws, rods, and cross-connectors. Top-loading and top-tightening mechanism. Mechanical fixation via rigid locking of polyaxial screws.

Indications for Use

Indicated for skeletally mature patients requiring non-cervical pedicle and non-pedicle fixation as an adjunct to fusion. Treats degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and failed previous fusion.

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

• S4 Spinal System (K130291, K123939, K123352, K112551, K100623, K090657, K071945, K062085, K032219)
• EXPEDIUM Spinal System (K090230, K082942, K041119, K073364, K070300)
• Polaris Spinal System (K151974, K133746, K123549, K090203, K111957)

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

December 14, 2016

Aesculap Implant Systems, LLC Mr. Paul Amudala Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K162134

Trade/Device Name: ENNOVATE Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWQ Dated: November 8, 2016 Received: November 14, 2016

Dear Mr. Amudala:

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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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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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)

### K162134

Device Name ENNOVATE Spinal System

### Indications for Use (Describe)

The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograff or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities.

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).

- 2. Spondylolisthesis,
- 3. Trauma (i.e., fracture or dislocation)
- 4. Spinal Stenosis.
- 5. Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- 6. Tumor.
- 7. Pseudoarthrosis, and
- 8. Failed previous fusion

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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### B. 510(k) SUMMARY (as required by 21 CFR 807.92)

| Aesculap Implant Systems ENNOVATE Spinal System<br>Nov 08, 2016 | |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| COMPANY: | Aesculap Implant Systems, LLC<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 300567331 |
| CONTACT: | Paul Amudala |
| | 610-984-9303 (phone)<br>610-791-6882 (fax) |
| TRADE NAME: | ENNOVATE Spinal System |
| COMMON NAME: | ENNOVATE Spinal System |
| REGULATION NUMBER: | 888.3070 - Pedicle screw spinal system |
| PRODUCT CODE: | NKB, MNI, MNH, and KWQ |
| CLASS: | Class III |
| REVIEW PANEL: | Orthopedics |

### SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems, LLC believes that the ENNOVATE Spinal System is substantially equivalent to the Primary Predicate K130291 S4 Spinal System (including K123939, K123352, K112551, K100623, K090657, K071945, K062085, and K032219), and the Additional Predicates EXPEDIUM® Spinal System (K090230,K082942, K041119, K073364, and K070300), and Polaris™ Spinal System (K151974, K133746, K123549, K090203, and K111957).

### DEVICE DESCRIPTION

The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. This system includes polyaxial screws of varying diameters and lengths, rod-to-rod and cross connectors of various styles and lengths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V), conforming to ISO 5832-3.

The ENNOVATE Spinal System is a spinal rod and screw system. This system's polyaxial screws can be rigidly locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. Rods of this system may be shaped intraoperatively to correct or maintain proper spinal curvature.

### INDICATIONS FOR USE

The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended

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to be used as an adjunct to fusion using autograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities.

- 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies),
- 2. Spondvlolisthesis.
- 3. Trauma (i.e., fracture or dislocation)
- 4. Spinal Stenosis,
- 5. Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- 6. Tumor,
- 7. Pseudoarthrosis, and
- 8. Failed previous fusion

### TECHNOLIGICAL CHARACTERISTICS (compared to Predicate(s))

The components of the ENNOVATE Spinal System are offered in similar configuration as the predicate devices. All of the implants are made from a Titanium Alloy (Ti-6Al-4V). The instruments are made of medical grade silicone, stainless steel, titanium alloy and PEEK which are the same materials as the Primary and Reference Predicate devices.

### PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the guidance "Spinal System 510(k)s May 3, 2004" was completed where applicable.

- . Dynamic/Static compression tests and static torsion tests per ASTM F1717-15.
- . Dynamic compression/tension test per ASTM F2193-14.
- . Dynamic/Static flexion bending tests, Static rod grip and Static rod/cross rod torsion tests per ASTM F1798-13.
- . Axial compression, pull out strength, driving torque test per ASTM F543-13.

### CONCLUSION:

Aesculap believes that based on the completed testing, the Ennovate Spinal System presented in this submission is substantially equivalent in design, materials, intended use, and performs as safely and effectively as the primary predicate and reference predicates currently on the market.

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