← Product Code [NKB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NKB) · K133086 # TITLE 2 POLYAXIAL SPINAL SYSTEM (K133086) _Zimmer Spine, Inc. · NKB · Nov 27, 2013 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NKB/K133086 ## Device Facts - **Applicant:** Zimmer Spine, Inc. - **Product Code:** [NKB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NKB.md) - **Decision Date:** Nov 27, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3070 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## 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 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 Story TiTLE® 2 Polyaxial Spinal System; rod and top-loading screw fixation system; temporary construct for spinal stabilization during posterior fusion procedures; implants include screws, rods, and connection components; surgical placement via open or endoscopic techniques; system removed after solid fusion; links to Minit® Posterior Cervical and Upper Thoracic Fixation System; aids surgical correction of spinal instabilities/deformities; benefits patient by providing immobilization to assist normal healing. ## Clinical Evidence Bench testing only. Performed static axial compression, static torsion, axial compression fatigue (ASTM F1717-12), and static/dynamic gripping/flexion-extension testing (ASTM F1798-97). Cadaver lab testing conducted to evaluate human factors regarding instrument and labeling design changes. Biocompatibility and sterilization/dry time testing confirmed equivalence. ## Technological Characteristics Rod and top-loading screw fixation system. Implants: Titanium alloy (Ti-6AI-4V ELI) per ASTM F136. Instruments: Stainless Steel per ASTM A564 and ASTM F899. Non-sterile, single-use. Polyaxial design. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - TITLE® 2 Polyaxial Spinal System ([K073510](/device/K073510.md)) - TITLE® 2 Polyaxial Spinal System ([K072840](/device/K072840.md)) - TITLE® 2 Polyaxial Spinal System ([K070367](/device/K070367.md)) - TITLE® 2 Polyaxial Spinal System ([K060990](/device/K060990.md)) - TITLE® 2 Polyaxial Spinal System ([K041808](/device/K041808.md)) ## Reference Devices - Minit® Posterior Cervical and Upper Thoracic Fixation System ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## 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 System
Predicate Device Name | Submission ID
Number | 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 | {1}------------------------------------------------ ## General 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. #### 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 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 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. {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ ## 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 {5}------------------------------------------------ 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 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. 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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NKB/K133086](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NKB/K133086) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com