NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM

K141253 · New Era Orthopaedics, LLC · MNI · Jan 9, 2015 · Orthopedic

Device Facts

• Record ID: K141253
• Device Name: NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM
• Applicant: New Era Orthopaedics, LLC
• Product Code: MNI · Orthopedic
• Decision Date: Jan 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The New Era Orthopaedics Polyscrew Pedicle Screw System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion. The New Era Orthopaedics Polyscrew Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

Device Story

Posterior spinal fixation system; consists of pedicle screws, rods, and cross-links. Used by surgeons in clinical settings to immobilize and stabilize spinal segments. Components implanted during spinal fusion surgery to treat deformities, fractures, or instabilities. Provides mechanical support to facilitate bone fusion; implants removed after solid fusion achieved in specific severe spondylolisthesis cases. System design matches patient anatomy via varied component sizes.

Clinical Evidence

No clinical studies were performed.

Technological Characteristics

Posterior spinal fixation system. Materials: Ti-6Al-4V (ASTM F136) and CoCr (ASTM F1537). Components include pedicle screws, rods, and cross-links. Mechanical testing performed per ASTM F1717 (static/dynamic compression, static torsion) and dissociation testing.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Treats thoracic, lumbar, and sacral spine instabilities/deformities including degenerative spondylolisthesis, fractures, dislocations, scoliosis, lordosis, spinal tumors, pseudarthrosis, failed fusion, and spinal stenosis. Specific indication for severe spondylolisthesis (grades 3-4) at L5-S1 using autogenous bone graft with L3-sacrum fixation.

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

• CREO™ Stabilization System - Globus Medical (K124058)
• Xia Spinal System - Stryker (K071373 / K113666)
• Synergy VLS - open (K940631 / K950099)
• Moss Miami SS - DePuy Spine (K000536)
• PWB (now Synergy) (K920116)
• Polyaxial LP - Scient'x (K062912)
• CD Horizon - Medtronic (K132328)

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

January 9, 2015

New Era Orthopaedics, LLC % Mr. J.D. Webb The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K141253

Trade/Device Name: New Era Orthopaedics Polyscrew Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: December 8, 2014 Received: December 10, 2014

Dear Mr. Webb:

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 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/Resourcesfor You/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 yours,

# Lori A. Wiggins -S

for 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) K141253

### Device Name

New Era Orthopaedics Polyscrew Pedicle Screw System

### Indications for Use (Describe)

The New Era Orthopaedics Polyscrew Pedicle Screw System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The New Era Orthopaedics Polyscrew Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(k) Summary

### for the New Era Orthopaedics Polyscrew Pedicle Screw System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the New Era Orthopaedics Polyscrew Pedicle Screw System

#### 1. GENERAL INFORMATION

| Date Prepared: | January 7, 2015 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | New Era Orthopaedics Polyscrew Pedicle Screw System |
| Common Name: | pedicle screw system |
| Classification Name: | Pedicle Screw Spinal System |
| Class: | II |
| Product Code: | MNI<br>MNH |
| CFR section: | 21 CFR section 888.3070 |
| Device panel: | Orthopedic |
| Primary Predicate<br>Device: | CREO™ Stabilization System - Globus Medical (K124058) |
| Additional Predicate<br>Devices: | Xia Spinal System - Stryker (K071373 / K113666)<br>Synergy VLS - open (K940631 / K950099)<br>Moss Miami SS - DePuy Spine (K000536)<br>PWB (now Synergy) (K920116)<br>Polyaxial LP - Scient'x (K062912)<br>CD Horizon - Medtronic (K132328) |
| Submitter: | New Era Orthopaedics, LLC<br>1214 Research Boulevard, Suite 1019<br>Hummelstown, PA 17036<br>717-585-6785 Tele |
| Contact: | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>512-388-0199 Tele<br>512-692-3699 Fax<br>e-mail: [e-mail] |

### 2. DEVICE DESCRIPTION

The New Era Orthopaedics Polyscrew Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to more closely match the patient's anatomy.

### Materials:

Ti-6Al-4V per ASTM F136 CoCr per ASTM F1537

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### 3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

The New Era Orthopaedics Polyscrew Pedicle Screw System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.

### 4. INTENDED USE

The New Era Orthopaedics Polyscrew Pedicle Screw System is 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The New Era Orthopaedics Polyscrew Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, and/or lordosis), turnor; pseudoarthrosis; and failed previous fusion.

### 5. NON-CLINICAL TEST SUMMARY

The following tests were conducted:

- . Static and dynamic compression per ASTM F1717
- . Static torsion per ASTM F1717
- Dissociation testing

The results of this testing indicate that the New Era Orthopaedics Polyscrew Pedicle Screw System is equivalent to predicate devices.

### 6. CLINICAL TEST SUMMARY

No clinical studies were performed

### 7. CONCLUSIONS NONCLINICAL AND CLINICAL

New Era Orthopaedics, LLC considers the New Era Orthopaedics Polyscrew Pedicle Screw System to be equivalent to the predicate device listed above. This conclusion is based upon the device's similarities in principles of operation, technology, materials and indications for use