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. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft. The device is indicated for all the following indications: 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, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion.

The Ballista/Ballista II instruments are intended to be used with Ballista/Ballista II/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista II instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications: 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, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion that warrant the use of a noncervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft.

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, 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. The system includes screws, various types and sizes of rods, locking nuts, hooks, lateral connectors, plugs, fixation washers, rod connectors/dominos and various cross connectors. Various instruments are also available for use by the surgeon to facilitate implantation of the device. This submission is a line extension to Polaris Spinal System to add another style of Ballista rods to the system.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Polaris Spinal System - Ballista II Rods," a non-cervical spinal fixation device. This submission is a line extension to add another style of Ballista rods to the existing system. The core assertion is that the new components are "substantially equivalent" to predicate devices, meaning they have the same or similar technological characteristics and do not raise new issues of safety or effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness (Substantial Equivalence)	The new Ballista II rods are substantially equivalent to predicate rods (K121130 & K061441) with respect to intended use and indications, technological characteristics, and principles of operation. No new issues of safety or effectiveness are presented.
Mechanical Performance	An engineering analysis concluded that mechanical testing was not required for this specific style of rod because the combination of components did not create a new worst-case construct.
Compatibility with System Instruments	Validation testing was conducted to verify that the modified rods can be used with the system's instrumentation.

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

Sample Size: Not applicable in the context of this submission. The "study" here is primarily an engineering analysis and validation testing, not a clinical study on human subjects or a dataset in the typical sense for AI/machine learning.
Data Provenance: Not applicable. The validation testing would have been performed in a laboratory setting by the manufacturer, Biomet Spine. The data is internal to the company.

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

Number of Experts: Not applicable. This submission focuses on engineering analysis and mechanical/compatibility testing, not on establishing ground truth from expert interpretations of medical data.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. There is no human interpretation of data requiring adjudication mentioned.

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

No, an MRMC comparative effectiveness study was not done. The submission focuses on device equivalence from a mechanical and functional perspective, not on comparing human reader performance with or without AI assistance.

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

No, a standalone study (in the context of an algorithm's performance) was not done. This is a hardware device submission, not an AI or software device submission.

7. The Type of Ground Truth Used:

Ground Truth: The "ground truth" in this context is defined by established engineering principles, mechanical testing standards for spinal implants, and the functional compatibility requirements with existing instrumentation. This is engineering/performance data and manufacturing specifications.

8. The Sample Size for the Training Set:

Not applicable. This submission does not involve an AI system with a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. This submission does not involve an AI system with a "training set."

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" in this context consists of an engineering analysis and validation testing.

Engineering Analysis: This analysis was conducted to determine if new mechanical testing was required for the different style of rod. The conclusion was that because the new component combination did not create a "new worst-case construct" compared to the predicate devices, additional general mechanical testing of the rod itself was not deemed necessary to demonstrate substantial equivalence for the main mechanical properties.
Validation Testing: This testing specifically verified the compatibility and functionality of the modified rods with the existing Polaris Spinal System instrumentation. This ensures that surgeons can safely and effectively use the new rods with the established toolset.

The overall approach to proving the device meets acceptance criteria (which is primarily substantial equivalence) relies on demonstrating that the new components maintain the same intended use, indications, technological characteristics, and principles of operation as legally marketed predicate devices, and that the minor modifications do not introduce new safety or effectiveness concerns, supported by engineering analysis and specific compatibility testing.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in large, bold, sans-serif font, with the "O" in "BIOMET" being a perfect circle. Below "BIOMET" is the word "SPINE" in a smaller, sans-serif font. The logo is black and white.

510(k) Summar K123451

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

Preparation Date:	November 30, 2012
Applicant/Sponsor:	Biomet Spine100 Interpace ParkwayParsippany, NJ 07054
Contact Person:	Vivian KellyRegulatory Affairs Project ManagerPhone: 973-299-9300 x2214Fax: 973-257-0232
Trade name:	Polaris Spinal System -Ballista II Rods
Common Name:	Non-cervical spinal fixation system
Classification Name(Product Code):	Posterior, noncervical, nonpedicle use (KWP)Anterior/anterolateral noncervical use (KWQ)Noncervical pedicle applications (MNI, MNH and NKB)
Device Panel - RegulationNo.:	Orthopedic - 21 CFR 888.3050, 888.3060 and 888.3070

Device Description:

Indications for Use:

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 systerior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft. The device is indicated for all the following indications: 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, kyphosis, and/or lordosis), turnor, stenosis, pseudoarthrosis, or failed previous fusion.

The Ballista/Ballista II instruments are intended to be used with Ballista II /Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista II instruments to provide the surgeon with a perculaneous approach for posterior spinal surgery for the following indications: 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, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion that warrant the

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use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft.

Summary of Technologies:

The technological characteristics of the new components are the same as, or similar to, the predicate devices. The proximal end of the subject device has been modified to remove bulk and to have a dimple and 3 flats instead of the slot and hole design of the predicate device.

Performance Data:

An engineering analysis was conducted to determine if mechanical testing was required for a different style of rod. Because this combination of components did not create a new worst case construct, additional mechanical testing was not required to demonstrate substantial equivalence. Validation testing was conducted to verify that the modified rods can be used with the system's instrumentation.

Substantial Equivalence:

The Ballista II rods in the Polaris Spinal System are substantially equivalent to the other rods in Polaris Spinal System cleared in K121130 and K061441.These new rods are substantially equivalent to the predicate rods with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness.

Conclusion:

The subject device is substantially equivalent to its predicates (K121130 & K061441) when used as a spinal fixation device. The indications for use and fundamental technology of the device remain unchanged. Furthermore, validation testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject device to the other components in the Polaris Spinal System. Based on this information, the subject device does not raise any new issues regarding the safety or efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 3, 2012

BIOMET Spine (AKA EBI, LLC) % Ms. Vivian Kelly MS, RAC Regulatory Affairs Project Manager 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K123451

Trade/Device Name: Polaris Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: November 09, 2012 Received: November 09, 2012

Dear Ms. Kelly:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 -- Ms. Vivian Kelly MS, RAC]

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erin I Keith

Mark N. Méikerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K123451 510(k) Number (if known):

Device Name: Polaris Spinal System

Indications for Use:

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 CDRH, Office of Device Evaluation (ODE)

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Ronald P. Jean

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123451

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.