The Radius® Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the Radius Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: 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 Radius Spinal System can also be linked to the Xia® Titanium Spinal System via the Ø5.5 mm to Ø6.0 mm Radius® rod-to-rod connector.

Device Description

This 510(k) is intended to introduce an extension to the existing Radius ® Spinal System. The proposed line extension includes the additional screws, rods, and cross connectors.

AI/ML Overview

The provided text describes a Special 510(k) Premarket Notification for a line extension to the Radius Spinal System. It focuses on demonstrating substantial equivalence to predicate devices through mechanical performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What the device needed to achieve)	Reported Device Performance (What the device actually achieved)
Mechanical performance comparable to predicate devices.	The results obtained from Static Compression Bending testing, Static Torsion testing, and Fatigue Compression Bending testing per ASTM F1717 were compared to those of a predicate system to demonstrate substantial equivalence.

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

The document does not explicitly state the sample size for the mechanical performance tests. It mentions that "tests were conducted" without specifying the number of components or repetitions. The data provenance is described as being generated through in-vitro mechanical testing conducted by the manufacturer, Stryker Spine. It is not patient data, so "country of origin of the data," "retrospective or prospective" are not applicable in this context.

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

Not applicable. The ground truth for this device is based on objective mechanical testing against industry standards (ASTM F1717) and comparison to predicate devices, not expert human assessment.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment is based on objective mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a mechanical implant, not an AI-assisted diagnostic or therapeutic tool. There is no human reader component to its evaluation.

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

Not applicable. This device is a mechanical implant, not an algorithm. However, the mechanical testing can be considered "standalone" in that it evaluates the device's physical properties independently.

7. The Type of Ground Truth Used

The ground truth used is based on:

Industry Standard Mechanical Testing: Adherence to ASTM F1717 for Static Compression Bending, Static Torsion, and Fatigue Compression Bending.
Comparison to Predicate Devices: Performance results were compared to a legally marketed predicate system to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical implant and does not involve AI algorithms that require a "training set" in the conventional sense.

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

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

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the Radius Spinal System line extension meets its acceptance criteria is a mechanical performance testing study. This study involved:

Testing Method: Static Compression Bending testing, Static Torsion testing, and Fatigue Compression Bending testing, all conducted according to ASTM F1717.
Comparison: The results from these tests on the new components of the Radius Spinal System were compared to those of a predicate system.
Outcome: The comparison demonstrated substantial equivalence in terms of mechanical performance between the new components and the predicate devices. This approach aligns with the recommendations provided in the "Guidance for Industry & FDA Staff Spinal System 510(k)s, May 3, 2004."

The ultimate acceptance criterion for this device, based on the 510(k) process, is demonstrating substantial equivalence to its predicate devices, particularly in terms of material, design, mechanical performance, and indications for use. The mechanical testing described is the mechanism through which this equivalence for performance was established.

Summary

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K101144 Page 1/2

Radius Spinal System - Line Extension

Special 510(k) Premarket Notification

JUL - 8 2010

STRYKER SPINE Special 510(k) Summary of Safety and Effectiveness:

Proprietary Name:	Radius ® Spinal System
Common Name:	Spinal Fixation Appliances
Classification Name and Reference:	1) Pedicle Screw Spinal System, 21 CFR §888.3070
	2) Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050
	3) Spinal Intervertebral Body Fixation Orthosis 21 CFR §888.3060
Proposed Regulatory Class:	Class III
Device Product Code:	NKB, KWP, KWQ, MNH, MNI
For Information contact:	Curtis Truesdale
	Regulatory Affairs Project Manager
	2 Pearl Court
	Allendale, NJ 07401
	Telephone: (201) 760-8296
	Fax: (201) 760-8496
	Email: Curtis.Truesdale@Stryker.com
Date Summary Prepared:	July 7, 2010
Predicate Devices	Stryker Spine Radius® Spinal System, K070631, K062270, K082608Medtronic CD Horizon (Legacy) Spinal System, K020709DePuy Spine Moss Miami System, K950697
Description of Device Modification	This 510(k) is intended to introduce an extension to the existing Radius ® Spinal System. The proposed line extension includes the additional screws, rods, and cross connectors.

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101144 Page 1/2

Radius Spinal System - Line Extension

Special 510(k) Premarket Notification

Intended Use

. 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);
t spinal stenosis;
. curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
. tumor;
. pseudoarthrosis; and
. failed previous fusion.

The Radius® Spinal System can also be linked to the Xia® Titanium Spinal System via the Ø5.5 mm to Ø6.0 mm Radius® rod-to-rod connector.

Documentation is provided which demonstrates the new components of the Stryker Spine Radius® Spinal System to be substantially equivalent to the predicate devices in terms of material, design. mechanical performance and indications for use. Static Compression Bending testing, Static Torsion testing and Fatigue Compression Bending testing per ASTM F1717 were conducted on the Radius Spinal System components. The results obtained from these tests were compared to those of a predicate system to demonstrate substantial equivalence, as recommended by the "Guidance for Industry & FDA Staff Spinal System 510(k)s, May 3, 2004."

Page 2 of 2

Summary of the Technological Characteristics

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered horizontally in the image. The background of the image is white.

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

JUL - 8 2010

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

Re: K101144

Trade/Device Name: Radius® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP, KWQ Dated: June 09, 2010 Received: June 10, 2010

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. 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

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Page 2 - Mr. Curtis Truesdale

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 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,

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): < / 0 // / // // // // // // // // // // // //

Device Name: Radius® Spinal System Line Extension - additional screws, rods & connectors.

Indications for Use:

The Radius Spinal System can also be linked to the Xia® Titanium Spinal System via the Ø5.5 mm to Ø6.0 mm Radius® rod-to-rod connector.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices

KIO!! 44 510(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.