The XENON Pedicle Screw System is intended for posterior, non-cervical 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 and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. It is intended to provide stabilization during the development of fusion utilizing autograft or allograft bone graft.

Device Description

The system is comprised of XENON standard polyaxial screws, hightop polyaxial screws, set screws, rods. The XENON polyaxial screw features a dual lead thread, 3 prong drive instrument interface and is self tapping. The polyaxial screws are offered in various diameters ranging from 4.5mm to 8.0mm and lengths ranging from 25mm and 80mm. The polyaxial screws range of motion is 50 degrees Medial/Lateral and 50 degrees Inferior/superior. The 5.5mm diameter rods are offered in lengths 35mm to 600mm. The rods are also offered in two profiles, straight and precontoured. The adjustable bridges are offered in 4 different sizes. The implants are manufactured from surgical grade titanium alloy (Ti6AI-4V).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the XENON™ Pedicle Screw System meets them, based on the provided document:

This document is a 510(k) summary for a medical device (XENON™ Pedicle Screw System), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results against predefined acceptance criteria for a novel device. Therefore, much of the requested information regarding sample sizes, expert involvement, and ground truth establishment, which are typical for clinical performance studies of AI/diagnostic devices, is not present in this type of submission.

The "acceptance criteria" here are implicitly the performance standards set by recognized consensus standards for spinal implant mechanical testing, and the "proof" is that the device met these standards and was substantially equivalent to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance (XENON™ Pedicle Screw System)
ASTM F1717 for Spinal Implants	Demonstrated substantial equivalence to the predicate Zodiac Polyaxial Spinal Fixation System device. Performance testing covered:
	- Dynamic Compression Bending
	- Static Torsion
	- Static Compression Bending
Substantial Equivalence	Similar in terms of general design, intended use, and technological characteristics to the predicate devices (Zodiac® 4.0 Polyaxial Spinal Fixation System, Zodiac® Polyaxial Spinal Fixation System, Apelo™ Pedicle Screw System).

Note: The document states that the testing "demonstrated that XENON Pedicle Screw System is substantially equivalent to the predicate Zodiac Polyaxial Spinal Fixation System device." This implies that the XENON system met or exceeded the performance of the predicate device when tested against ASTM F1717. Specific numerical thresholds for these tests are not provided in this summary but would be part of the full test reports.

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

Test Set Sample Size: Not applicable/not specified in this 510(k) summary. The "test set" here refers to the device specimens used for mechanical testing, not patient data. The number of physical units tested to satisfy ASTM F1717 standards is not disclosed in this summary.
Data Provenance: Not applicable. This study involves mechanical testing of physical device components, not human data.

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

Number of Experts: Not applicable. Ground truth as typically defined for AI or diagnostic devices (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for mechanical testing is established by the specifications and outcomes of the standardized tests (ASTM F1717) and the performance of the predicate device.
Qualifications of Experts: Not applicable. Material scientists, engineers, and technicians would be involved in conducting and interpreting the mechanical tests according to industry standards.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Mechanical testing results are typically objective measurements, not subject to human adjudication in the same way clinical diagnoses or image interpretations are. Calibration and adherence to test protocols ensure consistency.

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 device is a pedicle screw system, not an AI or diagnostic tool that requires human interpretation of medical cases. The study was mechanical testing of physical hardware.

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

Standalone Study: Yes, in a broad sense. The "standalone" performance here refers to the mechanical performance of the device itself, without human intervention once the tests begin. However, this terminology typically applies to AI algorithms. For this device, it implies that the mechanical tests measured the intrinsic properties and performance of the pedicle screws and system components independent of surgical implantation technique (which would involve human-in-the-loop aspects).

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for this submission is established by recognized consensus standards (ASTM F1717) for mechanical testing of spinal implants and the demonstrated performance of the predicate device when subjected to these same standards. The "truth" is that the XENON system's mechanical capabilities are equivalent to a device already deemed safe and effective.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This submission describes mechanical testing, not a machine learning model. There is no "training set" in this context.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of submission.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the Greek letter alpha in bold font above the words "Uptake Spine" in a stylized font. The letter alpha is in a sans-serif font and is larger than the words below it. The words "Uptake Spine" are in a serif font with a slight slant to the right. The image is in black and white.

JAN 2 5 2012

510(k) SUMMARY

XENON™ Pedicle Screw System November 2011

Company:

Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 Direct: (760) 494-6770 (760) 431-0289 Fax:

Contact Person:	Cheryl Allen, Sr. Regulatory Affairs Submissions Specialist
Trade/Proprietary Name:	XENON™ Pedicle Screw System
Common Name:	Pedicle Screw Spinal Device
Classification Names:	Pedicle Screw Spinal System
Device Classification:	Class III per 21 CFR 888.3070
Product Code(s):	NKB, MNL, MNH

Product Code(s): NKB, MNI, MNH

Product Description:

Indications for Use:

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the text "510(k) Number K111634 Page 2/2". It appears to be a page number and a 510(k) number, which is a premarket submission to the FDA to demonstrate that the device to be marketed is as safe and effective as a legally marketed device. The page number indicates that this is page 2 of 2.

Image /page/1/Picture/2 description: The image contains the text "Alphatec Spine" in a stylized, bold font. The text appears to be a logo or brand name, possibly for a medical or healthcare company specializing in spinal products or services. The font is distinctive and easily recognizable, suggesting a strong brand identity.

Substantial Equivalence:

Alphatec Spine has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the XENON Pedicle Screw System is substantial equivalent in the intended use, design materials, mechanical and functional characteristics compatred to the predicate devices. The XENON Pedicle Screw System is substantially equivalent to the following predicate devices:

Trade/Proprietary Model Name

Zodiac® 4.0 Polyaxial Spinal Fixation System Zodiac® Polyaxial Spinal Fixation System Apelo" Pedicle Screw System

Manufacturer Alphatec Spine, Inc. Alphatec Spine, Inc. Atlas Spine, Inc.

510(k) No. K071890 K100685 K110842

Performance Data:

Mechanical static and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use. Performance testing was performed per the recognized consensus standards and per the guidance document, Spinal 510(k)s- Guidance for Instustry and FDA Staff. The following testing was performed per ASTM F1717:

Dynamic Compression Bending �
. Static Torsion
Static Compression Bending .

The testing demonstrated that XENON Pedicle Screw System is substantially equivalent to the predicate Zodiac Polyaxial Spinal Fixation System device. It is similar in terms of general design, intended use, and technological characteristics to the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle-like bird with three stripes forming its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JAN 2 5 2012

Alphatec Spine, Inc. % Ms. Cheryl Allen 5818 El Camino Real Carlsbad, California 92008

Re: K111634

Trade/Device Name: XENON™ 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: January 18, 2012 Received: January 20, 2012

Dear Ms. Allen:

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

{3}------------------------------------------------

Page 2 - Ms. Cheryl Allen

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 CI IT rated adverse events) (21 CFR 803); good manufacturing practice requirements as set de rice-related daverse overse (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 11 you desire specific ad rice to: your conters Offices/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 note the regulation intiness ding 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 Tou may other bant. Beforeturers, 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

ely yours,

Mark N. Melke Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/2 description: The image shows the words "Alphatec Spine" in a stylized font. The word "Alphatec" is written in a bold, slightly slanted font, with each letter clearly visible. Below "Alphatec", the word "Spine" is written in a similar font, completing the phrase. The text appears to be part of a logo or branding material, possibly for a medical company specializing in spinal products or treatments.

INDICATIONS FOR USE

510k) Number (if known):

Device Name: XENON™ Pedicle Screw System

Indications for Use:

Prescription Use X (Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

Page 1 of 1

(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, Crthopedic, and Restorative Devices

KIII634 510(k) Number_

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.