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 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

AI/ML Overview

The provided document describes the New Era Orthopaedics Polyscrew Pedicle Screw System, a Class II medical device. As a Class II device approved through the 510(k) pathway, its approval hinges on demonstrating "substantial equivalence" to a predicate device, not necessarily on meeting specific numerical acceptance criteria in the same way a novel device might.

Therefore, the "acceptance criteria" for this device are implicitly tied to the performance of its predicate devices, as demonstrated through non-clinical testing. The study provided focuses on proving this substantial equivalence through mechanical testing.

Here's the breakdown of the information requested based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For 510(k) submissions, explicit numerical "acceptance criteria" and "reported device performance" in the typical sense of a novel device study are often not stated. Instead, the performance is reported as meeting or being equivalent to the predicate device, which implies satisfying the predicate's established safety and effectiveness.

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Performance: The device system (New Era Orthopaedics Polyscrew Pedicle Screw System) must demonstrate equivalent or superior mechanical performance in terms of static and dynamic compression, static torsion, and dissociation compared to its predicate devices, as evaluated using recognized ASTM F1717 standards. This implies that the device should withstand similar forces and exhibit comparable stability and durability to established pedicle screw systems without premature failure or degradation.	Non-Clinical Test Summary: The New Era Orthopaedics Polyscrew Pedicle Screw System underwent the following tests: - 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.
Material Compatibility: The materials used (Ti-6Al-4V per ASTM F136; CoCr per ASTM F1537) must be biocompatible and suitable for implantation in the human body, consistent with materials used in predicate devices.	Materials: Ti-6Al-4V per ASTM F136 and CoCr per ASTM F1537 were used, which are standard, biocompatible materials for such implants and are consistent with those found in predicate devices.
Functional Equivalence: The device's design, intended use, and general operational principles must be substantially equivalent to the predicate devices.	Substantial Equivalence Claim: The New Era Orthopaedics Polyscrew Pedicle Screw System is claimed to be substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety, and performances.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a numerical sample size for the non-clinical mechanical tests (static/dynamic compression, static torsion, dissociation). For mechanical testing of medical devices, sample sizes are typically determined by statistical requirements to achieve confidence in the measurements, but are not usually reported as a single "test set sample size" in the same way as a clinical study. Instead, multiple units of each component or assembly configuration would be tested to derive statistical data (e.g., mean, standard deviation, and comparisons to predicate device performance limits).
Data Provenance: The data provenance is from non-clinical laboratory testing. The document does not specify the country of origin for the testing, but it is typically conducted in controlled laboratory environments in accordance with international (ASTM) standards. This is not retrospective or prospective in a clinical sense, as it refers to laboratory experiments.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: This question is not applicable to this type of submission. Ground truth, in the context of device performance, is established through standardized engineering tests (e.g., ASTM F1717) and comparison to established predicate device performance and regulatory standards, not through expert consensus on qualitative data.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: This question is not applicable. Mechanical tests are quantitative and objective; their outcomes are measured directly based on physical properties and responses to applied forces, not through an adjudication process like one might find in a clinical trial or image interpretation study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, comparing their performance with and without AI assistance. The New Era Orthopaedics Polyscrew Pedicle Screw System is a physical implant, not a diagnostic tool requiring human interpretation of results in this manner.
Effect Size of Human Readers: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: This question is not applicable. This device is a physical pedicle screw system, not an algorithm or AI software. Therefore, there is no "standalone performance" in the context of an algorithm. Its performance is its mechanical integrity and function as a physical implant.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this device's performance is established by objective mechanical performance standards (e.g., ASTM F1717) and comparison to the established performance of legally marketed predicate devices. The implicit ground truth is that the device must be safe and effective, similar to existing devices, as demonstrated by meeting standardized mechanical testing requirements and being made of recognized biocompatible materials.

8. The Sample Size for the Training Set

Sample Size for Training Set: This question is not applicable. This device is not an AI/algorithm that requires a "training set." The engineering and design process for such a physical device involves iteration and testing, but not in the sense of a machine learning training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: This question is not applicable as there is no "training set" for a physical implant device in the context of this submission.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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

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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:	MNIMNH
CFR section:	21 CFR section 888.3070
Device panel:	Orthopedic
Primary PredicateDevice:	CREO™ Stabilization System - Globus Medical (K124058)
Additional PredicateDevices:	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)
Submitter:	New Era Orthopaedics, LLC1214 Research Boulevard, Suite 1019Hummelstown, PA 17036717-585-6785 Tele
Contact:	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Tele512-692-3699 Faxe-mail: jdwebb@orthomedix.net

2. DEVICE DESCRIPTION

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.

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

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
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.
(b)
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.