The Spinal Edge TITAN Pedicle Screw Systems is intended for posterior, noncervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

Device Description

The Spinal Edge TITAN Pedicle Screw System consists of longitudinal rods, polyaxial screws, and transverse connectors. The Spinal Edge TITAN Pedicle Screw System components are available in titanium alloy conforming to ASTM F-136 specifications.

AI/ML Overview

The provided text describes the regulatory clearance of the Spinal Edge TITAN Pedicle Screw System. Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria in a table format. Instead, it relies on demonstrating comparable function and performance characteristics to the predicate device as the primary acceptance criterion. The performance is reported in relation to relevant industry standards.

Acceptance Criteria (Implicit)	Reported Device Performance
Comparable function to predicate device	Representative samples underwent testing to demonstrate comparable function and performance characteristics to the predicate device.
Comparable performance characteristics to predicate device	Testing was completed in accordance with ASTM F1717 "Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model." Specifically, the longest pedicle screw (part number SE-112-CA-5.75 55mm length screw) was tested to provide the greatest potential for bending stress, implying it met the performance requirements under these conditions.
Made of the same materials as predicate device	"The Spinal Edge TITAN Pedicle Screw System... are made of the same materials" (titanium alloy conforming to ASTM F-136 specifications).
Same indications for use as predicate device	"The Spinal Edge TITAN Pedicle Screw System and its predicate device(s) have the same indications for use."
Same operating principles as predicate device	"The Spinal Edge TITAN Pedicle Screw System and its predicate device(s) have... operating principles."

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

Sample Size: The document mentions "Representative samples of the device" were tested. However, the exact sample size (e.g., number of screws, number of constructs) used for the mechanical testing is not specified.
Data Provenance: The testing methodology ("ASTM F1717 'Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model'") describes a laboratory-based, ex-vivo (or simulated in-vitro) test. Therefore, it's not applicable to "country of origin of the data" or "retrospective/prospective" in the clinical sense, as it's a mechanical performance study.

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

This information is not applicable to this type of device and study. The "ground truth" here is objective mechanical performance measured against a standard, not expert interpretation of clinical data. The ASTM F1717 standard itself defines the "ground truth" in terms of physical properties and behaviors under specified loads.

4. Adjudication Method for the Test Set:

This information is not applicable. Mechanical testing against a standard does not involve an adjudication method in the way clinical studies or image interpretations do. The results are typically quantitative measurements compared directly to specified limits or benchmarks.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is involved. The TITAN Pedicle Screw System is a physical implant, and its performance is assessed through mechanical testing, not through human reading of cases.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable. The device is a surgical implant, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used:

The ground truth used for this study is based on engineering standards and established material science properties. Specifically, the ASTM F1717 standard defines the appropriate testing methodology and expected performance characteristics for spinal implant constructs in a vertebrectomy model. The "ground truth" is therefore objective mechanical strength, stiffness, and fatigue resistance as measured against the parameters defined by this engineering standard.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical implant, not a machine learning model. Therefore, there is no "training set."

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

This information is not applicable as there is no training set for this type of device.

Summary

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K091110

10.0 510(k) Summary

JUL 2 4 2009

1. Sponsor
  Spinal Edge LLC 2275 Research Blvd. Suite 527 Rockville, MD 20805

Primary Contact:	Ravi Sharma PhD
Telephone:	1- 866-915-9468

March 20, 2009 Date Prepared:

2. TITAN Pedicle Screw System:

Proprietary Name:	TITAN Pedicle Screw System
Common/Usual Name:	Pedicle Screw Spinal System
Classification Name:	Pedicle Screw Spinal System(21 CFR 888.3070), Class II Product Codes MNH, MNI

3. Predicate Devices

K030383 - DePuy 5.5 Moss Miami Ti K024348, K023438, K021335 - DePuy AcroMed MONARCH Spine System

4. Device Description

5. Intended Use

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6. Technological Characteristics and Substantial Equivalent

The Spinal Edge TITAN Pedicle Screw System and its predicate device(s) have the same indications for use, operating principles and are made of the same materials.

Representative samples of the device underwent testing to demonstrate comparable function and performance characteristics to the predicate device.

7. Performance Testing

The testing method for the TITAN Pedicle Screw System was completed in accordance with ASTM F1717 "Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model". Part number SE-112-CA-5.75 55mm length screw was used for testing. The longest pedicle screw was tested to provide greatest potential for bending stress.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2009

Spinal Edge LLC % Ms. Christina Vacca President 33650 Reserve Way Avon. Ohio 44011

Re: K091110

Trade/Device Name: Titan Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw system Regulatory Class: Class II Product Code: MNH, MNI Dated: June 30, 2009 Received: July 7, 2009

Dear Ms. Vacca:

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 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. Christina Vacca

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/ucm11.5809.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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Barbara Bush

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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9.0 Indications for Use Statement

510(k) Number (if Known): K091110

Indications for Use:

The Spinal Edge TITAN Pedicle Screw Systems is intended for posterior, noncervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

Prescription Use: _ X AND/OR Over-The-Counter Use: (Part 21 CFR 801 Subpart D) (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Jivision Sign-Off) Jivision of Surgical, Orthopedic, and Restorative Devices

Number K 09110

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.