XIA 4.5 SPINAL SYSTEM by STRYKER SPINE

The XIA® 4.5 Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications:

Degenerative disc disease (DDD) (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, kyphosis, and/or lordosis);
Tumor; .
. Pseudoarthrosis; and
. Failed previous fusion.
The Stryker Spine DIAPASON™ Spinal System, OPUS™ Spinal System and XIA® Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.

Device Description

This 510(k) is intended to introduce an extension to the existing XIA® 4.5 Spinal System. The proposed line extension includes the addition of titanium Screws (monoaxial, polyaxial and reduction) and rod-to-rod connectors.

AI/ML Overview

This document describes a 510(k) premarket notification for a line extension of the XIA 4.5 Spinal System. It is not a study that proves a device meets acceptance criteria through clinical or AI performance evaluation. Instead, it demonstrates substantial equivalence to existing predicate devices based on material, design, and indications for use. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and AI performance is not applicable to this submission.

Here's why and what the document does provide:

Nature of the Submission: This is a "Special 510(k) Premarket Notification" for a line extension to an existing Class III spinal system. The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove absolute safety and effectiveness through extensive new clinical trials or performance studies involving algorithms.
Focus of the "Study": The document states: "Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 were completed for the systems." This refers to bench testing and engineering analysis (e.g., mechanical strength, fatigue, material compatibility) to ensure the new components (titanium screws and rod-to-rod connectors) meet established performance standards for spinal fixation devices and are comparable to the predicate devices. It is not a clinical study involving patients, or an AI performance study.

Therefore, the following requested information is not present or applicable in this 510(k) submission:

Table of acceptance criteria and reported device performance (in the context of clinical or AI performance): The "acceptance criteria" here are likely mechanical and material specifications met through engineering tests against regulatory guidance, not clinical outcome metrics.
Sample size for the test set and data provenance: No clinical test set involving human subjects or AI algorithms is described.
Number of experts used to establish ground truth and qualifications: Ground truth in the context of clinical or AI performance is not applicable here.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was conducted or reported.
Standalone (algorithm-only) performance: No AI algorithm is part of this device.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an engineering-focused 510(k).
Sample size for the training set: No AI training set.
How the ground truth for the training set was established: Not applicable.

What is present in the document related to "acceptance criteria" and "study":

Acceptance Criteria (Implied - Regulatory & Engineering): The devices are substantially equivalent to predicates, meaning they meet the same safety and performance profiles as those devices. This is demonstrated through adherence to FDA guidance for spinal system 510(k)s, which would involve mechanical testing standards (e.g., fatigue, static bending), material biocompatibility, and sterilization validation. The "Indications for Use" statement also acts as a boundary for acceptance.
Study (Type of "Study" Performed): "Engineering analysis and testing" were performed. This is typically bench testing (in vitro mechanical tests) rather than human clinical trials. These tests ensure the new components perform equivalently to the predicate devices and meet relevant ISO or ASTM standards for spinal implants.

Summary

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XIA 4.5 Spinal System - Line Extension

Special 510(k) Premarket Notification

Special 510(k) Summary of Safety and Effectiveness: XIA® 4.5 Spinal System - Line Extension

Proprietary Name:	XIA® 4.5 Spinal System	DEC - 8 2009
Common Name:	Spinal Fixation Appliances
Classification Name and Reference:	1) Spinal Interlaminal Fixation Orthosis, 21 CFR §888.30502) Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.30603) Pedicle Screw Spinal System, 21 CFR §888.3070 (b) (1) & (b) (2)
Device Product Code:	NKB, KWP, KWQ, MNH, MNI
Proposed Regulatory Class:	Class III
For Information contact:	Curtis TruesdaleRegulatory Affairs Project Manager2 Pearl CourtAllendale, NJ 07401Telephone: (201) 760-8296Fax: (201) 760-8496Email: Curtis.Truesdale@Stryker.com
Date Summary Prepared:	December 2, 2009
Predicate Devices	Stryker Spine XIA 4.5 Spinal System, K050461, K060361; Stryker Spine XIA 4.5 Spinal System, K060748, K060979; Stryker Spine Xia® 3 Spinal System, K071373, K083393; Stryker Spine Xia® II Spinal System, K063428; Medtronic CD Legacy Spinal System, K020709; Stryker Spine Moss Miami Spinal System, K950697.

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Description of Device Modification

Intended Use

Special 510(k) Premarket Notification

The XIA® 4.5 Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications:

Degenerative disc disease (DDD) (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, kyphosis, and/or lordosis);
Tumor; .
. Pseudoarthrosis; and
. Failed previous fusion.

The Stryker Spine DIAPASON™ Spinal System, OPUS™ Spinal System and XIA® Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.

Summary of the Technological Characteristics

The Stryker Spine XIA® 4.5 Spinal Systems, with the incorporation of the subject components, is substantially equivalent to the predicate devices in terms of material, design, and indications for use. Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 were completed for the systems.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Stryker Spine % Mr. Curtis Truesdale Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401

DEC - 3 2009

Re: K092605

Trade/Device Name: XIA 4.5 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWP, KWQ, MNH, MNI Dated: November 4, 2009 Received: November 5, 2009

Dear Mr. Truesdale:

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.

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

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Page 2 - Mr. Curtis Truesdale

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 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark M. Wilkerson

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: XIA® 4.5 Spinal System Line Extension - additional screws (monoaxial, polyaxial, and reduction) and rod-to rod connectors

Indications for Use:

The XIA® 4.5 Spinal System is intended for anterior/anteriolateral and posterior, noncervical pedicle and non-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);
l Spondylolisthesis;
1 Trauma (i.e. fracture or dislocation);
Spinal stenosis;
Curvatures (i.e. scoliosis, kyphosis, and/or lordosis); 트
발 Tumor;
י Pseudoarthrosis; and
Failed previous fusion. l

The Stryker Spine DIAPASON™ Spinal System, OPUS™ Spinal System and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.

Prescription Use X (21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

(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 Sign-C . ) Division of Surgical. Orthopedic, and Restorative Levices

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.