ATLAS SPINE PEDICLE SCREW SYSTEM

K110842 · Atlas Spine, Inc. · NKB · Jul 13, 2011 · Orthopedic

Device Facts

• Record ID: K110842
• Device Name: ATLAS SPINE PEDICLE SCREW SYSTEM
• Applicant: Atlas Spine, Inc.
• Product Code: NKB · Orthopedic
• Decision Date: Jul 13, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Apelo™ Pedicle Screw System is intended for noncervical pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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; pseudarthrosis; and failed previous fusion.

Device Story

Apelo™ Pedicle Screw System consists of spinal pedicle fixation hardware; line extensions include new sizes of solid monoaxial/polyaxial screws and cannulated monoaxial/polyaxial screws (non-fenestrated). Used by surgeons in open or minimally invasive spinal procedures to provide stabilization as an adjunct to fusion. Screws are implanted into patient anatomy to provide structural support. Device selection is based on patient-specific anatomy. Benefits include stabilization of the spinal column in patients with degenerative or traumatic conditions. No software or algorithmic components involved.

Clinical Evidence

Bench testing only. Dynamic compression bending testing was performed in accordance with ASTM F1717 to evaluate mechanical performance and ensure no new worst-case construct was created.

Technological Characteristics

Pedicle screw spinal system; materials and manufacturing processes consistent with predicate devices; includes solid and cannulated monoaxial and polyaxial screw designs; mechanical testing conducted per ASTM F1717.

Indications for Use

Indicated for noncervical pedicle fixation in skeletally mature patients as an adjunct to spinal fusion for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, 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

• Atlas Spine Pedicle Screw System (K072426)
• Expedium™ MIS Spine System (K041801)
• XIA® Spinal System (K043473)

Reference Devices

• XIA® 4.5 Spinal System
• Stryker Spine (K092605)

Submission Summary (Full Text)

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## |<110842

Atlas Spine, Inc. Alas Spine, mo:
Special 510(k) Premarket Notification: Apelo™ Pedicle Screw System
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### 510(k) SUMMARY

| Manufacturer:<br>Address:<br>Telephone:<br>Fax: | Atlas Spine, Inc.<br>1555 Jupiter Park Drive, Suite #4<br>Jupiter, FL 33458<br>561-741-1108<br>561-741-1870 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Establishment Reg. No. | 3003855635 |
| Official Correspondent:<br>Title:<br>Telephone: | Thomas G. Smith<br>Manager, Regulatory Affairs & Quality Assurance<br>561-354-4318 |
| Date Prepared: | March 23, 2011 |
| Device Classification<br>Name: | Spinal pedicle fixation orthosis |
| Trade/Proprietary Name: | Apelo™ Pedicle Screw System |
| Common Name: | Pedicle screw spinal system |
| Classification: | Class III per 21 CFR §888.3070 |
| Product Code: | MNI, MNH, and NKB |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Devices: | Atlas Spine Pedicle Screw System<br>Atlas Spine, Inc.<br>K072426 |
| | Expedium™ MIS Spine System<br>DePuy AcroMed, Inc.<br>K041801 |
| | XIA® Spinal System<br>Stryker Spine<br>K043473 |
| | XIA® 4.5 Spinal System |

1.F2

Stryker Spine K092605

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### KI10842

#### Atlas Spine, Inc. Special 510(k) Premarket Notification: Apelo Pedicle Screw System ==============================================================================================================================================================================

#### Intended Use:

The Apelo™ Pedicle Screw System is intended for noncervical pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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; pseudarthrosis; and failed previous fusion.

#### Description of Device Modification:

Being proposed in this Special 510(k) is the introduction of line extensions to the existing Apelo™ Pedicle Screw System. The proposed line extensions consist of new sizes of solid monoaxial and polyaxial pedicle screws and cannulated monoaxial and polyaxial pedicle screws without fenestrations. The new design and sizes of pedicle screws will be offered in order to provide surgeons a variety of screws from which to choose for open and minimally invasive procedures based on patients' anatomies.

#### Equivalence to Marketed Product

Atlas Spine, Inc. has submitted information to demonstrate that, for the purpose of FDA 's regulation of medical devices, the Apelo" Pedicle Screws are substantially equivalent in the intended use, design, materials mechanical, and functional characteristics compared to the predicate devices. The new 4.5mm solid (non-cannulated) diameter screw is identical in terms of intended use, material, and manufacturing processes to the solid monoaxial and polyaxial pedicle screws described more fully in the reference premarket notification, K072426. Dynamic compression bending testing according to ASTM F1717 was conducted to generate two runout samples. Results showed that the proposed screws do not create a new worst case construct. The 4.5mm to and including 8.5mm diameter cannulated pedicle screws are similar in terms of intended use, material and manufacturing processes to the referenced predicate devices [ref. K041801, K043473 and K0926051.

#### Conclusion

Provided documentation demonstrates that the proposed Apelo™ Pedicle Screws are substantially equivalent to the aforementioned predicate devices. This conclusion is based on the devices' similarities in indications for use, design, function, materials and mechanical function.

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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 circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines and two wave-like shapes at the bottom.

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

JUL 13 2011

Atlas Spine, Inc. % Mr. Thomas G. Smith Manager, Regulatory Affairs and Quality Assurance 1555 Jupiter Park Drive, Suite 4 Jupiter, Florida 33458

Re: K110842

Trade/Device Name: Apelo™ 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: June 10, 2011 Received: June 13, 2011

Dear Mr. Smith:

J

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.

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Page 2 - Mr. Thomas G. Smith

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 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/ucm115809.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/Resourcesfor You/Industry/default.htm.

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

Sincerely yours,

Ernie Keith

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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### 14110842

Atlas Spine, Inc. Special 510(k) Premarket Notification: Apelo"" Pedicle Screw System -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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# Indications for Use

12110842 510(k) Number (if known):

Device Name: Apelo™ Pedicle Screw System

Indications for Use:

The Apelo™ Pedicle Screw System is intended for noncervical pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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; pseudarthrosis; and failed previous fusion.

Prescription Use X (Part 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)

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

KI1084 2 510(k) Number_

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