STREAMLINE TL SPINAL SYSTEM

K110692 · Pioneer Surgical Technology, Inc. · NKB · May 12, 2011 · Orthopedic

Device Facts

• Record ID: K110692
• Device Name: STREAMLINE TL SPINAL SYSTEM
• Applicant: Pioneer Surgical Technology, Inc.
• Product Code: NKB · Orthopedic
• Decision Date: May 12, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Streamline TL Spinal System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (T1-S2), sacral/iliac screw fixation or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthosis, and failed previous fusion.

Device Story

Streamline TL Spinal System is a spinal fixation construct consisting of rods, pedicle screws, connectors, and set screws. System includes cross-links (Quantum X-Link and FixxSure Cross Link) to provide added construct stability. Components are tailor-made for individual patient anatomy and rigidly locked into configurations during surgery. Used by surgeons in clinical settings to facilitate spinal fusion. Device provides mechanical stabilization of the spine; benefits patient by supporting healing in cases of deformity, trauma, or degenerative disease. No software or automated processing involved.

Clinical Evidence

Bench testing only. ASTM F1717 dynamic compression bending, static compression bending, and static torsion testing were performed to characterize the performance of the Streamline TL construct with the added FixxSure Crosslink.

Technological Characteristics

Construct components (screws, set screws, connectors) made of Titanium Alloy (ASTM F136). Rods made of Titanium Alloy (ASTM F136) or Cobalt Chromium Molybdenum Alloy (ASTM F1537). Mechanical fixation system; no energy source, software, or connectivity.

Indications for Use

Indicated for skeletally mature patients requiring non-cervical spinal fixation as an adjunct to fusion. Conditions include degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), deformities (scoliosis, kyphosis, lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

Regulatory Classification

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

• Streamline TL Spinal System (K093692)
• SpineWorks FixxSure Cross Link (K081331)

Submission Summary (Full Text)

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## 长110692

MAY 1 2 2011

## 510(k) Summary

| Sponsor: | Pioneer Surgical Technology, Inc.<br>375 River Park Circle<br>Marquette, MI 49855<br>[phone]<br>Contact: Emily M. Downs<br>Date prepared: April 15, 2011 | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Device Name: | Streamline TL Spinal System | |
| Classification Name: | 888.3060, Spondylolisthesis Spinal Fixation Device System and 888.3070 Pedicle Screw Spinal<br>System, Class III | |
| Product Codes: | NKB, KWQ, MNH, MNI, Panel Code 87 | |
| Predicate Device: | K093692 - Streamline TL Spinal System (SE date - August 11, 2010)<br>K081331 - SpineWorks FixxSure Cross Link (SE date - July 23, 2008) | |
| Description: | The Streamline TL Spinal System consists of a variety of rods, pedicle screws, connectors, set<br>screws and other connection components used to build a spinal construct. Cross-links available for<br>use with the Streamline TL system include the Quantum X-Link and the SpineWorks FixxSure<br>Crosslink. The implant components can be rigidly locked into a variety of configurations, with<br>each construct being tailor-made for the individual case. Instrumentation is also available to<br>facilitate implant of device components. | |
| | The purpose of this submission is to include the FixxSure Cross Link to the Streamline TL System.<br>The Cross Link is designed to provide added fixation to the spinal construct and is available in<br>fixed (23-28mm) and variable lengths (28-66mm). | |
| Intended Use: | The Streamline TL Spinal System components are non-cervical spinal fixation devices intended as<br>an adjunct to fusion for use as a pedicle screw (T1-S2), sacral/iliac screw fixation or as an<br>anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature<br>patients. These devices are indicated for all of the following indications: degenerative disc disease<br>(defined as discogenic back pain with degeneration of the disc confirmed by history and<br>radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), deformities or<br>curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis,<br>pseudoarthosis, and failed previous fusion. | |
| Material: | Screws, Set Screws, and Connecting components are comprised of Titanium Alloy per ASTM F136.<br>Rods are comprised of Titanium Alloy per ASTM F136 or Cobalt Chromium Molybdenum Alloy<br>per ASTM F1537. | |
| Performance Data: | ASTM F1717 dynamic compression bending, static compression bending and static torsion testing<br>was presented to characterize the performance of the Streamline TL construct with the additional<br>FixxSure Crosslink. | |
| | The test results demonstrate that the addition of the FixxSure Crosslink to the Streamline TL system<br>functioned as intended and performed in a manner substantially equivalent to that of the predicate<br>system. | |
| Performance and SE<br>Determination: | Comparisons of device performance data, materials, indications and design/function to predicate<br>devices were provided in making a determination of substantial equivalence. | |

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Image /page/1/Picture/1 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 forming its body and legs. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference.

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

MAY 1 2 2011

Pioneer Surgical Technology, Inc. % Ms. Emily M. Downs 375 River Park Circle Marquette, Michigan 49855

Re: K110692

Trade/Device Name: Streamline TL Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWO Dated: April 15, 2011 Received: April 18, 2011

Dear Ms. Downs:

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 or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Ms. Emily M. Downs

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/CDRHQffices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcestorYourIndustry/default.htm.

Sincerely yours.

Aly B. R. for

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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## 2.0 Indications for Use Statement

K110692 510(k) Number (if known):

Device Name: Streamline TL Spinal System

Indications for Use: The Streamline TL Spinal System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (T1-S2), sacral/iliac screw fixation or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthosis, and failed previous fusion.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | √ |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR

| Over-the-Counter Use | |
|----------------------|--|
|----------------------|--|

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number k110692

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