The TiTLE 2 Polyaxial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The TiTLE 2 Polyaxial Spinal 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 neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The TiTLE 2 Polyaxial Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

In addition, TiTLE 2 Polyaxial System, when not used with pedicle screws, is indicated for sacral screw fixation from T1 to the illium sacrum. The non-pedicle screw indications are spondylolisthesis, degeneralive disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis, and kyphosis), tumor, fracture, and previous failed fusion surgery.

The TiTLE 2 Polyaxial System can also be linked to the Minit® Posterior Cervical and Upper Thoracic Fixation System.

Device Description

The TiTLE® 2 Polyaxial Spinal System Implants are intended to be used as a temporary construct that assists in normal healing and are not intended to replace normal body structures. The system is intended to stabilize the spinal operative site during posterior fusion procedures, attaching to the spine by means of screws joined with spinal rods and should be removed after fusion.

The TiTLE® 2 Polyaxial Spinal System is designed to aid in the surgical correction of several types of spinal conditions, as stated in the section below. The TiTLE® 2 Polyaxial Spinal System consists of screws, rods, connection components that are intended to be used as a temporary construct that assists in normal healing and are not intended to replace normal body structures. The system is intended to stabilize the spinal operative site during posterior fusion procedures, attaching to the spine by means of screws joined with spinal rods and should be removed after fusion. The polyaxial spinal system is a rod and top-loading screw fixation system. This system can be placed surgically using either open or endoscopic surgical techniques. The system is provided non-sterile, for single use only.

The TiTLE® 2 Polyaxial Spinal System can also be linked to the Minit® Posterior Cervical and Upper Thoracic Fixation System.

AI/ML Overview

The Zimmer Spine TiTLE® 2 Polyaxial Spinal System is a medical device and its "acceptance criteria" and "study" refer to the performance testing and resulting substantial equivalence determination by the FDA, rather than clinical efficacy studies often associated with AI/software devices. Therefore, the information provided corresponds to the regulatory requirements for medical devices.

Acceptance Criteria and Device Performance

The acceptance criteria for the TiTLE® 2 Polyaxial Spinal System are based on establishing substantial equivalence to its predicate devices concerning design, materials, function, and intended use. The device's performance was evaluated through various types of testing, the results of which confirmed its suitability for its intended use and its substantial equivalence to the predicate.

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance (Bench Testing)	Confirmed product performance is suitable for intended use based on: - Static Axial Compression (Bending) per ASTM F1717-12 - Static Torsion per ASTM F1717-12 - Axial Compression (Bending) Fatigue per ASTM F1717-12 - Static Axial Gripping Capacity per ASTM F1798-97 (Reapproved 2008) - Static Torsion Gripping Capacity per ASTM F1798-97 (Reapproved 2008) - Static Flexion-Extension Moment per ASTM F1798-97 (Reapproved 2008) - Dynamic Flexion-Extension Moment per ASTM F1798-97 (Reapproved 2008)
Human Factors (Cadaver Lab Testing)	Confirmed substantial equivalence of design changes (instrument and labeling) and interaction with implants compared to predicate devices.
Biocompatibility	Ensured materials are biocompatible after manufacturing, based on minor design changes compared to predicate devices.
Sterilization & Dry Time	Ensured steam sterilization and dry time requirements and instructions are substantially equivalent to the predicate devices.
Overall Substantial Equivalence	Considered substantially equivalent to predicate devices due to no changes in product performance specifications or device functional scientific technology. This determination was reviewed and accepted by the FDA (K133086).

Study Information (Applicable to medical device regulatory context)

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

The document does not specify a distinct "test set" in the context of AI or software performance evaluation. Instead, testing was conducted on manufactured components of the TiTLE® 2 Polyaxial Spinal System.

Bench Testing: The sample size for mechanical testing (implants, screws, rods, and connection components) is not explicitly stated in terms of number of units tested, but it refers to "components of the subject TiTLE® 2 Polyaxial Spinal System" being reviewed and tested.
Cadaver Lab Testing: The sample size (number of cadavers or tests) for evaluating human factors is not specified.
Data Provenance: The studies were conducted by Zimmer Spine, Inc. for regulatory submission to the FDA. This indicates the testing was performed internally or by contracted labs for the manufacturer, in the context of a prospective submission for marketing authorization.

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

This question is not applicable in the context of this device's regulatory review. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F1717-12, ASTM F1798-97) and internal design specifications, not by expert consensus on clinical data. For human factors, the evaluation likely involved surgical or relevant medical professionals, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This concept is not directly applicable to the type of performance testing described for this medical device. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or for establishing ground truth in AI/software evaluations, particularly when human expert disagreement needs to be resolved. The performance testing here follows established engineering and biological standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to evaluate the impact of AI on human reader performance for diagnostic or screening tasks. The TiTLE® 2 Polyaxial Spinal System is a physical implantable medical device, not an AI or diagnostic software.

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. This concept is relevant for AI/software devices. The performance testing for the TiTLE® 2 Polyaxial Spinal System focused on the physical and mechanical properties of the device itself.

7. The Type of Ground Truth Used

The "ground truth" for this medical device generally refers to:

Engineering Standards: Compliance with established ASTM standards (F1717-12, F1798-97) for mechanical properties.
Biocompatibility Standards: Compliance with standards for material safety.
Design Specifications: Meeting internal design requirements for function and form.
Predicate Device Performance: The predicate device itself served as a benchmark for "substantially equivalent" performance.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the way it would be defined for AI/software or diagnostic devices.

8. The Sample Size for the Training Set

This question is not applicable. The TiTLE® 2 Polyaxial Spinal System is a physical medical device, not an AI or machine learning model that requires a training set.

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

This question is not applicable, as there is no training set for this type of medical device.

Summary

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Zimmer Spine - 510(k) - TiTLE® 2 Polyaxial Spinal System - Appendix A

Image /page/0/Picture/2 description: This document is a 510(k) Summary for the TITLE® 2 Polyaxial Spinal System. It includes the date of summary preparation as September 27, 2013, and the submitter as Zimmer Spine, Inc. located in Minneapolis, MN. The document also lists the establishment registration number, primary and secondary company contacts, trade name, device name, device classification as Class III, product codes, regulation numbers, and a description of the regulation.

legally marketed predicate devices:

TITLE® 2 Polyaxial Spinal SystemPredicate Device Name	Submission IDNumber	Clearance Date
TITLE® 2 Polyaxial Spinal System	K073510	February 11, 2008
TITLE® 2 Polyaxial Spinal System	K072840	December 7, 2007
TITLE® 2 Polyaxial Spinal System	K070367	April 12, 2007
TITLE® 2 Polyaxial Spinal System	K060990	April 26, 2006
TITLE® 2 Polyaxial Spinal System	K041808	October 1, 2004

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General Device Description:

The TiTLE® 2 Polyaxial Spinal System can also be linked to the Minit® Posterior Cervical and Upper Thoracic Fixation System.

Indications for Use:

The TiTLE 2 Polyaxial Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (grades 3 and 4) at L5-S1, in skefetally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

In addition, TiTLE 2 Polyaxial System, when not used with pedicle screws, is indicated for sacral screw fixation from T1 to the illum sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, and kyphosis), tumor, fracture, and previous failed fusion surgery.

The TiTLE 2 Polyaxial System can also be linked to the Minit® Posterior Cervical and Upper Thoracic Fixation System.

Summary of Technological Characteristics:

The subject TiTLE® 2 Polyaxial Spinal System shares the same technological characteristics as its predicate device, TiTLE® 2 Polyaxial Spinal System. The characteristics include the same design, same materials, same range of sizes and, substantially equivalent performance characteristics and intended use.

The subject and predicate TiTLE® 2 Polyaxial Spinal System both consist of screws, rods, connection components and the instruments necessary to implant the spinal system. All implant components are made from medical grade titanium alloy (Ti-6AI-4V ELI) that meets ASTM F136. The delivery instruments are manufactured from Stainless Steel that meets ASTM A564 and ASTM F899.

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The TiTLE® 2 Polyaxial Spinal System is designed to aid in the surgical correction of several types of spinal conditions, as stated in the section above. The TiTLE® 2 Polyaxial Spinal System consists of screws, rods, connection components that are intended to be used as a temporary construct that assists in normal healing and are not intended to replace normal body structures. The system is intended to stabilize the spinal operative site during posterior fusion procedures, attaching to the spine by means of screws joined with spinal rods and should be removed after fusion. The oolvaxial system is a rod and top-loading screw fixation system. This system can be placed surgically using either open or endoscopic surgical techniques. The subject and predicate systems are provided non-sterile, are for single use only.

Summary of Performance Testing:

The TiTLE® 2 Polyaxial Spinal System is substantially equivalent to the predicate devices in design, materials, function and intended use.

The performance testing included components of the subject TiTLE® 2 Polyaxial Spinal System, which were reviewed and tested appropriately for design verification, design validation, biocompatibility and sterilization. The test results conclude the subject TiTLE® 2 Polyaxial Spinal System to be substantially equivalent to its predicate device, TiTLE® 2 Polyaxial Spinal System.

Bench testing (Static Axial Compression (Bending), Static Torsion, and Axial . Compression (Bending) Fatique per ASTM F1717-12; and Static Axial Gripping Capacity, Static Torsion Gripping Capacity, Static Flexion-Extension Moment, and Dynamic Flexion-Extension Moment per ASTM F1798-97 (Reapproved 2008)) for implants, screws, rods, and connection component, confirmed the product performance of the subject TiTLE® 2 Polvaxial Spinal System is suitable for its intended use.
Cadaver lab testing of the subject TiTLE® 2 Polyaxial Spinal System to evaluate human . factors regarding the combination of instrument design changes and labeling design changes, as well as interaction with implants to confirm the substantial equivalence of the changes compared to the identified predicate devices.
. Biocompatibility testing ensured the subject TiTLE® 2 Polyaxial Spinal System materials are biocompatible after manufacturing based on the minor design changes made in comparison to the predicate devices.
Sterilization, and Dry Time testing ensured the subject TiTLE® 2 Polyaxial System . steam sterilization, and dry time requirements and instructions are substantially equivalent to the predicate devices.

Substantial Equivalence:

Zimmer Spine considers the subject TiTLE® 2 Polyaxial Spinal System product performance to be substantially equivalent to its predicate device. TiTLE® 2 Polyaxial Spinal System because there are no changes to the product performance specifications or device functional scientific technology.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of promoting health, well-being, and human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 27, 2013

Zimmer Spine, Incorporated Ms. Michelle Lenz Regulatory Affairs Specialist 7375 Bush Lake Road Minneapolis, Minnesota 55439

Re: K133086

Trade/Device Name: TiTLE® 2 Polyaxial Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB. MNH. MNI, KWP Dated: September 27, 2013 Received: September 30. 2013

Dear Ms. Lenz:

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. Ilisting 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 cither 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 cvents) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Michelle Lenz

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson -S

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

Enclosure

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Zimmer Spine - 510(k) -- TiTLE® 2 Polyaxial Spinal System -- Section 4. Indications for Use Statement

Indications for Use

K133086 510(k) Number (if known):

Device Name:

TiTLE® 2 Polyaxial Spinal System

Indications for Use:

The TiTLE 2 Polyaxial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic . studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The TiTLE 2 Polyaxial System can also be linked to the Minit® Posterior Cervical and Upper Thoracic Fixation System.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)

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)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133086

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.