ATHENA PEDICLE SCREW SYSTEM

K110046 · Royal Oak Medical Devices · NKB · Dec 7, 2011 · Orthopedic

Device Facts

• Record ID: K110046
• Device Name: ATHENA PEDICLE SCREW SYSTEM
• Applicant: Royal Oak Medical Devices
• Product Code: NKB · Orthopedic
• Decision Date: Dec 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Athena Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. The system is intended for posterior, pedicle fixation as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Device Story

Athena Pedicle Screw System; spinal fixation hardware for posterior, pedicle use. Components: polyaxial pedicle screws, spinal rods, cross-connectors, set screws. Used by surgeons in clinical settings to provide immobilization and stabilization of spinal segments as an adjunct to fusion. Implanted during spinal surgery to treat acute/chronic instabilities or deformities. Benefits patient by stabilizing spine to facilitate fusion.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing included static and dynamic axial compression bending and static torsion testing conducted in accordance with ASTM F1717.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136. Components: Polyaxial pedicle screws, spinal rods, cross-connectors, set screws. Mechanical testing performed per ASTM F1717.

Indications for Use

Indicated for skeletally mature patients requiring immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. Treats degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (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

• Interpore Cross Synergy Polyaxial System (K950099/K974749)
• Rogozinski System (K930298/K983904)
• Depuv Spine Moss Miami System (K992168/K022623)

Submission Summary (Full Text)

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DEC - 7 2011

### Royal Oak Medical Devices Athena Pedicle Screw System

### 510(K) Summary

SUBMITTED BY

Royal Oak Medical Devices 39533 Woodward Avenue, Suite 175 Bloomfield Hills, MI 48304 USA

ESTABLISHMENT REGISTRATION NUMBER Pending

OWNER/OPERATOR NUMBER

CONTACT PERSON

SUBMISSION PREPARED BY

DATE PREPARED

CLASSIFICATION NAME

DEVICE CLASS

REGULATION NUMBER

COMMON NAME

PROPRIETARY NAME

IDENTIFICATION OF

Pending

Matthew Kroll Vice President of Technical Services Royal Oak Medical Devices Phone: [phone] Fax: [phone]

Anne Wilson QA Consulting, Inc. 9433 Bee Cave Road Bldg.1, Suite 140 Austin, TX 78733 Phone: [phone] Fax: [phone]

22 September 2011

Pedicle Screw Spinal System

Class III (product code NKB) Class II (product codes MNI, MNH)

NKB 888.3070 MNI 888.3070 MNH 888.3070

Spinal Fixation System

Athena Pedicle Screw System

The Athena Pedicle Screw System is

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PREDICATE DEVICE(S)

substantially equivalent to the Interpore Cross Synergy Polyaxial System (K950099/K974749), Rogozinski System (K930298/K983904) and Depuv Spine Moss Miami System (K992168/K022623)

### DEVICE DESCRIPTION

The Athena Pedicle Screw System is comprised of polyaxial pedicle screws in various diameters and lengths, spinal rods in various lengths, cross-connectors and set screws. The Athena Pedicle Screw System can be used for single or multiple level fixations. All implant components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

#### INDICATIONS:

The Athena Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. The system is intended for posterior, pedicle fixation as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies): spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The purpose of this submission is to obtain clearance to market the Athena Pedicle Screw System. The Athena Pedicle Screw System implants are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. The subject device has similar technological characteristics as the predicate devices identified above. Specifically, the following characteristics support this conclusion:

- । Same intended use.
- Substantially equivalent results of non-clinical testing relative to static and dynamic testing (per ASTM F1717).

#### DISCUSSION OF NON-CLINICAL TESTING

The following non-clinical tests were conducted, the results of which demonstrate that the Athena Pedicle Screw System is substantially equivalent to the predicate(s):

- Static and dynamic axial compression bending testing, conducted in । accordance with ASTM F1717
- Static torsion testing, conducted in accordance with ASTM F1717 -

#### CONCLUSIONS

The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Athena Pedicle Screw System is substantially equivalent to the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is simple, using only black and white, and is designed to be easily recognizable.

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

Royal Oak Medical Devices % Mr. Matthew Kroll Vice President of Technical Services 39533 Woodward Avenue, Suite 175 Bloomfield Hills, Michigan 48304

DEC - 7 2011

Re: K110046

Trade/Device Name: Athena Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: December 1, 2011 Received: December 2, 2011

### Dear Mr. Kroll:

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. Insting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Matthew Kroll

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE

### 510(k) Number: K110046

### Device Name: Athena Pedicle Screw System

### Indications for Use:

The Athena Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. The system is intended for posterior, pedicle fixation as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KI10046 510(k) Number_