The ODALYS™ Pedicle Screw System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system ODALYS™ Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (13 to sacrum) with removal of the implants after the attainment of a solid fusion.

Device Description

The ODALYS™ Pedicle Screw System has been developed with the objective of providing the surgeon with an adaptable fixation system in order to carry out dorsal stabilization of the spine simply, quickly and effectively.

The system consists of a variety of color coded top loading pedicle screws. The pedicle screws are available in various lengths and diameters. The screw is connected to the rod via a rod connector. Two sizes of connectors are available, short and long. The long is used in cases of spondylolisthesis where the short connector would not be able to engage the rod. The rods are available in multiple lengths.

Materials: The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136.

Function: The ODALYS™ Pedicle Screw System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments until fusion takes place.

AI/ML Overview

The provided text describes the ODALYS™ Pedicle Screw System, a medical device, and its acceptance criteria as determined by the FDA's 510(k) clearance process.

Here's an analysis of the acceptance criteria and the "study" (non-clinical tests) used to prove the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (ODALYS™ Pedicle Screw System)
Mechanical Performance (Static Compression Resistance)	Met or exceeded the performance of predicate devices: Moss Miami (K000536) and PWB Lumbosacral Spine System (K920116) as evidenced by ASTM F1717 testing.
Mechanical Performance (Dynamic Compression Resistance)	Met or exceeded the performance of predicate devices: Moss Miami (K000536) and PWB Lumbosacral Spine System (K920116) as evidenced by ASTM F1717 testing.
Mechanical Performance (Static Torsion Resistance)	Met or exceeded the performance of predicate devices: Moss Miami (K000536) and PWB Lumbosacral Spine System (K920116) as evidenced by ASTM F1717 testing.
Material Composition	The device is manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136, which is equivalent to materials used in predicate devices.
Intended Use (Immobilization and stabilization of spinal segments for fusion)	The ODALYS™ Pedicle Screw System is intended for immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for specific conditions (degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion), and for severe spondylolisthesis (Grades 3 and 4) of L5-S1. This matches the intended use of predicate devices.
Design and Function (Top-loading pedicle screws, rod connectors, rods to provide spinal stabilization)	The ODALYS™ Pedicle Screw System has a similar design (variety of color-coded top-loading pedicle screws, rod connectors, and rods) and function (immobilization and stabilization of spinal segments until fusion takes place) compared to predicate devices.

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

Sample Size: The document does not specify a "test set" in the context of human data. The testing performed was non-clinical, involving mechanical tests of the device. The sample size for these mechanical tests (e.g., number of screws or constructs tested for each configuration) is not provided in the summary.
Data Provenance: The data provenance is from non-clinical laboratory testing (mechanical testing per ASTM standards). There is no information regarding country of origin or whether it's retrospective or prospective, as it pertains to physical device testing, not human data.

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

This section is not applicable. The "ground truth" for this device, in the context of the 510(k) submission, is its mechanical performance and material properties. This is established by adherence to recognized ASTM standards for medical devices, rather than expert consensus on a dataset. The results are compared to predicate devices.

4. Adjudication Method for the Test Set

This section is not applicable. There was no human "test set" requiring adjudication. The assessment was based on objective mechanical testing results comparing the device to accepted standards and predicate device performance.

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

No, a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of medical images or data. The ODALYS™ Pedicle Screw System is a physical implant, not an AI-based diagnostic tool.

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

No, a standalone algorithm performance study was not done. The device is a physical implant; there is no AI algorithm associated with it.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

Compliance with recognized industry standards (ASTM F1717 and ASTM F136).
Substantial equivalence to legally marketed predicate devices in terms of intended use, design, materials, and function, as demonstrated by meeting or exceeding the mechanical performance and material specifications of those predicates.

8. The Sample Size for the Training Set

This section is not applicable. The ODALYS™ Pedicle Screw System is a physical pedicle screw system, not an AI or machine learning device that requires a "training set."

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

This section is not applicable for the same reason as point 8. There is no training set for this device.

Summary

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510(k) Summary for the ODALYS™ Pedicle Screw System

2011

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the ODALYS™ Pedicle Screw System

Date Prepared: May 11, 2011

	1. Submitter:	Contact Person:
	Dayne Popa	J.D. Webb
	Kalitec Direct, LLC	The OrthoMedix Group, Inc.
	555 Winderley Place - Suite 300	1001 Oakwood Blvd
	Maitland FL 32751	Round Rock, TX 78681
	Telephone: 407-545-2063	Telephone: 512-388-0199

2. Trade name:	ODALYS TM Pedicle Screw System
Common Name:	orthosis, pedicle screw system
Classification Name:	orthosis, spondylolisthesis spinal fixation
	orthosis, spinal pedicle fixation
	21 CFR Sec. 888.3070
	MNH
	MNI
	Class II

ന് Predicate or legally marketed devices which are substantially equivalent:

Moss Miami - K000536 (DePuy Spine) PWB Lumbosacral Spine System - K920116 (Cross Medical Products, Inc.)

4. Description of the device:

Materials:

The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136.

Function:

The ODALYS™ Pedicle Screw System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments until fusion takes place.

5. Substantial equivalence claimed to predicate devices:

The ODALYS™ Pedicle Screw System is substantially equivalent to the Moss Miami and PWB Lumbosacral Spine System in terms of intended use, design, materials used, and performance.

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page 2 of 2.

6. Intended Use:

7. Summary of Nonclincal Tests:

The following tests were conducted:

. Static and dynamic compression per ASTM F1717
Static torsion per ASTM F1717 .

The results of this testing indicate that the ODALYS™ Pedicle Screw System is equivalent to predicate devices.

8. Clinical Test Summary:

No clinical studies were performed

ல் Conclusions Nonclinical and Clinical:

The ODALYS™ Pedicle Screw System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

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

Kalitec Direct, LLC % The OrthoMedix Group. Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock. Texas 78681

SEP 2 1 2011

Re: K111370

Trade/Device Name: ODAL.YS Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH. MNI Dated: July 30. 2011 Received: August 02, 2011

Dear Mr. Webb:

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. J.D. Webb

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.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/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/Medica!Devices/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):

Device Name: ODALYS™ Pedicle Screw System

Indications for Use:

The ODALYS™ Pedicle Screw System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system ODALYS™ Pedicle Screw Systemis indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Prescription Use _ X _ (Part 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

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

510(k) Number K111320

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.