STAXX(R) SYSTEM

K133207 · Spine Wave, Inc. · MQP · Dec 6, 2013 · Orthopedic

Device Facts

Record IDK133207
Device NameSTAXX(R) SYSTEM
ApplicantSpine Wave, Inc.
Product CodeMQP · Orthopedic
Decision DateDec 6, 2013
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 888.3060
Device ClassClass 2
AttributesTherapeutic

Intended Use

The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System. The StaXx® XDL System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be used with autograft or allograft and supplemental spinal fixation. The StaXx® IB System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IB System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device. The StaXx® IBL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IBL System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

Device Story

StaXx System comprises expandable implants, interlocking wafers, cartridge, and surgical gun. Surgical gun delivers wafers from cartridge to implant to incrementally adjust height. Used in thoracolumbar/lumbar spine procedures; operated by surgeons. Implants made of PEEK-OPTIMA with barium sulfate and tantalum markers for fluoroscopic visualization. System restores vertebral height or facilitates intervertebral fusion. Benefits include height restoration and stabilization of spinal segments.

Clinical Evidence

Bench testing only. Evidence includes simulated use testing, insertion testing, and cadaveric testing to demonstrate performance equivalence to predicate systems.

Technological Characteristics

System components: expandable implants, interlocking wafers, cartridge, surgical gun. Materials: PEEK-OPTIMA, 6% Barium Sulfate, tantalum markers. Mechanical delivery of wafers to form stack. Standalone manual surgical instrument.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine (L2-S1) or thoracolumbar vertebral body replacement (T1-L5) due to tumor or trauma. DDD patients may have up to Grade I spondylolisthesis or retrolisthesis and require 6 months of failed non-operative treatment.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ DEC 0 6 2013 **Spine**WAVE # 510(k) Summary StaXx® System ## 1. Submitter Information Submitter: Address: Spine Wave, Inc. Three Enterprise Drive Suite 210 Shelton, CT 06484 Telephone: 203-712-1847 203-944-9493 Telefax: Contact: Joseph Mercado Date Prepared: December 3, 2013 - 2. Device Information Trade Name: StaXx® System Fusion Device Common Name(s): Classification Name(s): Spinal Intervertebral Body Fixation Orthosis; Intervertebral Fusion Device with Bone Graft, Lumbar Vertebral Body Replacement; Intervertebral Body Classification(s)/Code(s): Class II per 21 CFR 888.3060/MQP; Class II (special controls) per 21 CFR 888.3080/MAX ## 3. Purpose of Submission The purpose of this submission is to gain clearance for a new Surgical Gun to be used with the StaXx® Systems. ### 4. Predicate Device Information The StaXx® Systems described in this submission are substantially equivalent to the following predicates: | Predicate Device | Manufacturer | Most recent<br>510(k) No. | |-------------------|------------------|---------------------------| | StaXx® XD System | Spine Wave, Inc. | K121889 | | StaXx® XDL System | Spine Wave, Inc. | K102315 | | StaXx® IB System | Spine Wave, Inc. | K123461 | | StaXx® IBL System | Spine Wave, Inc. | K132719 | {1}------------------------------------------------ ## 5. Device Description The StaXx® Systems are composed of expandable implants and interlocking wafers, which are implanted through a delivery system that includes a Cartridge and a Surgical Gun. The Cartridge is inserted into the Surgical Gun which, when activated, sequentially delivers locking wafers from the Cartridge to the expandable implant. The wafers are designed to be inserted incrementally to form a stack and therefore attain the desired height. The StaXx® XD and XDL Systems are vertebral body replacement devices intended for use in the thoracolumbar spine (TI-L5). They are composed of wafers that are stacked into an expandable implant to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and contain tantalum markets for additional visualization under fluoroscopy. The StaXx® XD System is to be placed bilaterally while the StaXx® XDL System is to be placed unilaterally and both are to be used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System. The StaXx® IB and IBL Systems are intervertebral body fusion devices composed of wafers that are stacked into an expandable implant to adjust the height of the implant. The implants are to be used with autogenous bone graft material. The StaXx® IB implant components are manufactured from both PEEK-OPTIMA and PEEK-OPTIMA with 6% Barium Sulfate while the StaXx® IBL implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and tantalum markers. ### 6. Intended Use The StaXx® Systems have the following indications: The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allografi and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System. The StaXx® XDL System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed. damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be used with autograft or allograft and supplemental spinal fixation. {2}------------------------------------------------ The StaXx® IB System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IB System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device. The StaXx® IBL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IBL System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device. ### 7. Comparison of Technological Characteristics The substantial equivalence of the StaXx® Systems to the predicates is shown by similarity in intended use, indications for use, materials and performance. ### 8. Performance Data The following non-clinical tests were performed to demonstrate that the subject StaXx® Systems are substantially equivalent to the listed predicate devices: - Simulated Use Testing . - . Insertion Testing - . Cadaveric Testing ### 9. Conclusion Based on the indications for use, technological characteristics and comparison to the predicates, the subject StaXx® Systems have been shown to be substantially equivalent to the predicate devices identified in this submission, and do not present any new issues of safety or effectiveness. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 6, 2013 Spine Wave, Incorporated Mr. Joseph Mercado Regulatory Affairs Specialist 3 Enterprise Drive, Suite 210 Shelton, Connecticut 06484 Re: K133207 Trade/Device Name: StaXx * Surgical Gun Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MOP, MAX Dated: November 5. 2013 Received: November 6, 2013 Dear Mr. Mercado: 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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 events) (21 CFR 803); good manufacturing practice requirements as set {4}------------------------------------------------ #### Page 2 - Mr. Joseph Mercado 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 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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Lori A. Wiqqins - for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K133207 #### Device Name StaXx(R) Surgical Gun #### Indications for Use (Describe) The StaXx® Systems have the following indications: The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-LS) to replace and restore height of a collapsed, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System: The StaXx® XDL System is a vertebral body replacement device in the thoracolumbar spine (TI-LS) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof. due to turnor or trauma (i.e., fracture), The system is to be used with autograft or allograft and supplemental spinal fixation. The StaXx® IB System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IB System is to be used with and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device. The StaXx® IBL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IBL System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | | ---------------- | <br>Company Concessful Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Ch | <br>ANNO FOR A LA B | |------------------|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | Concurrence of t | Center for I | *or Devices and Radiological Health (CDRH) i | | Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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