The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system for use with autograft and/or allograft. The Polaris Spinal System is indicated for the following conditions: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, Scheuermann's disease, and/or lordosis,), tumor, stenosis, pseudoarthrosis, or failed previous fusion.

The Ballista and Cypher MIS instruments are intended to be used with Ballista/ Cypher MIS /Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/ Cypher MIS instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications.

For pediatric patients, the Polaris Spinal System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to fusion to treat adolescent idiopathic scoliosis and is also indicated for treatment of the following conditions: spondylolisthesis/spondylolysis and fractures caused by tumor and/or trauma. Pedicle screw fixation is limited to a posterior approach.

The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, Lineum OCT Spine System, the Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.

Device Description

The Polaris Spinal System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F136, unalloyed titanium per ASTM F67, stainless steel per ASTM F138 or ASTM F1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system includes screws, various types and sizes of rods, locking nuts, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. This submission is to clear modifications to Polaris Translation Screw and to update the labeling.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Polaris Spinal System - Translation Screw, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria	Reported Device Performance
Mechanical Testing	Static Compression Bending (ASTM F1717)	Met all mechanical test requirements based on worst-case construct testing.	Device met all mechanical test requirements based on the worst-case construct testing.
	Static Torsion (ASTM F1717)	Met all mechanical test requirements based on worst-case construct testing.	Device met all mechanical test requirements based on the worst-case construct testing.
	Dynamic Compression Bending Fatigue (ASTM F1717)	Met all mechanical test requirements based on worst-case construct testing.	Device met all mechanical test requirements based on the worst-case construct testing.
	Resistance to cantilever loading or non-axial torque	Ability to resist cantilever loading or non-axial torque comparable to the predicate device.	Testing verified the ability of the subject device to resist cantilever loading or non-axial torque compared to the predicate device.
Substantial Equivalence	Intended Use	Substantially equivalent to predicate devices.	Substantially equivalent to Polaris Spinal System predicate devices (K131615, K123549, K090203, K061441).
	Indications for Use	Substantially equivalent to predicate devices.	Substantially equivalent to Polaris Spinal System predicate devices.
	Design	Substantially equivalent to predicate devices.	Substantially equivalent to Polaris Spinal System predicate devices.
	Materials	Substantially equivalent to predicate devices.	Substantially equivalent to Polaris Spinal System predicate devices.
	Manufacturing Methods	Substantially equivalent to predicate devices.	Substantially equivalent to Polaris Spinal System predicate devices.
	Sterility	Substantially equivalent to predicate devices.	Substantially equivalent to Polaris Spinal System predicate devices.
	Fundamental Technology	Substantially equivalent to predicate devices.	Substantially equivalent to Polaris Spinal System predicate devices.
	Operational Principles	Substantially equivalent to predicate devices.	Substantially equivalent to Polaris Spinal System predicate devices.

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

The document describes mechanical testing as the primary method to demonstrate performance. For this, the sample size is not explicitly stated as a number of devices or constructs, but it mentions testing was performed on "worst-case construct testing." There is no information about country of origin or whether the data was retrospective or prospective, as this pertains to physical device testing rather than clinical data.

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

Not applicable. The performance data is based on mechanical laboratory testing against established ASTM standards and direct comparison to predicate devices, not on expert assessment of a test set.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the evaluation is based on objective mechanical testing in a laboratory setting, not on human adjudication of cases.

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

No, an MRMC comparative effectiveness study was not performed, nor is it relevant to this type of device (spinal fixation system modification). This document focuses on the mechanical substantial equivalence of a medical device, not the interpretive accuracy of human readers with or without AI assistance.

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

Not applicable. This device is a physical spinal implant, not an algorithm or AI system. Its performance is inherent in its mechanical properties and design.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

ASTM F1717 Standard: This standard dictates specific methods for static and fatigue testing of spinal implant constructs in a vertebrectomy model. Compliance with this standard represents a recognized and accepted "ground truth" for mechanical performance in this domain.
Predicate Device Performance: The primary ground truth for demonstrating "substantial equivalence" is the established safety and effectiveness of the legally marketed predicate devices (K131615, K123549, K090203, and K061441). The subject device's performance is compared directly to these.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for this type of device submission.

Summary

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APR 2 4 2014

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510(k) Summar

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.

Preparation Date:	April 22, 2014
Applicant/Sponsor:	Biomet Spine399 Jefferson RoadParsippany, NJ 07054
Contact Person:	Mike MedinaSenior Manager, Regulatory AffairsPhone: 303-501-8548Fax: 303-501-8444
Trade name:	Polaris Spinal System -Translation Screw
Common Name:	Non-cervical spinal fixation system
Device Class:	Class III
Classification Name(Product Code):	Posterior, noncervical, nonpedicle use (KWP)Anterior/anterolateral noncervical use (KWQ)Noncervical pedicle applications (MNI, MNH and NKB)Pedicle screw spinal system, adolescent idiopathic scoliosis (OSH)

Device Panel - Regulation No .: Orthopedic - 21 CFR 888.3050. 888.3060 and 888.3070

Device Description:

Indications for Use:

The Ballista and Cypher MIS instruments are intended to be used with Ballistal Cypher MIS/ Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the

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Ballista/ Cypher MIS instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications.

For pediatric patients. the Polaris Spinal System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to fusion to treat adolescent idiopathic scoliosis and is also indicated for treatment of the following conditions: spondylolisthesis/spondylolysis and fractures caused by tumor and/or trauma. Pedicle screw fixation is limited to a posterior approach.

The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, Lineum OCT. Spine System, the Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.

Summary of Technologies:

The technological characteristics of the subject Polaris Spinal System components remain the same as, or similar to, the predicate devices in regards to intended use, indications for use, design, materials, manufacturing methods, sterility, fundamental technology, and operational principles.

Performance Data:

Mechanical testing was conducted in accordance with FDA's Guidance for Industry and FDA Staff -- Spinal System 510(k)s dated Mav 3. 2004. Per the guidance document, the following testing was conducted: static compression bending, static torsion, and dynamic compression bending fatigue per ASTM F1717. Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model. Additional verification testing was conducted to compare the ability of the subject device to resist cantilever loading or non-axial torque as compared to the predicate device. The mechanical testing verifies that the subject components are substantially equivalent to other spinal systems currently on the market for its intended use and has met all mechanical test requirements based on the worst-case construct testing.

Substantial Equivalence:

The modified Polaris Translation Screw in the Polaris Spinal System is substantially equivalent to the Polaris Spinal System (K131615, K123549, K090203, and K061441) in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles.

Conclusion:

The Polaris Translation Screw is substantially equivalent to the predicate systems as spinal fixation devices in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles. Furthermore, mechanical testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject components to the Polaris Spinal System. which has been cleared for a non-cervical spinal fixation. Based on this information, the subject modifications do not raise any new issues regarding the safety or efficacy when compared to its predicates.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 24, 2014

Biomet Spine Mr. Mike Medina Senior Manager, Regulatory Affairs 399 Jefferson Road Parsippany, New Jersey 07054

Re: K140123

Trade/Device Name: Polaris Spinal System - Translation Screw Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNI, MNH, KWP, KWQ Dated: March 26, 2014 Received: March 27, 2014

Dear Mr. Medina:

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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Page 2 - Mr. Mike Medina

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/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 (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

·for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Biomet Spine Traditional 510(k) Premarket Notification

Indications for Use

510(k) Number (if known): _K140123

Device Name: Polaris Spinal System

The Polaris Soinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

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 OF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

James P. Bertram 2014.04.23 15:16:06 -04'00'

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K140123

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.