(61 days)
Not Found
No
The summary describes a mechanical spinal fixation system and associated instruments. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is a spinal fixation system designed to provide temporary stabilization during spinal fusion, which is a therapeutic intervention for various spinal conditions.
No.
The Vitality® Spinal Fixation System is a surgical implant and instrumentation system used for spinal fixation and fusion, not for diagnosing medical conditions.
No
The device description explicitly states it consists of spinal rods, pedicle screws, and connectors, which are hardware implants. It also includes instrumentation for insertion and removal.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Vitality® Spinal Fixation System is a surgical implant system designed to provide temporary stabilization to the spine during fusion. It is physically implanted into the patient's body.
- Lack of Specimen Analysis: The description and intended use do not mention any analysis of biological specimens.
Therefore, the Vitality® Spinal Fixation System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.
These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality® Spinal Fixation System is intended to be used with autograft and/or allograft.
In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The Vitality® System is intended to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.
Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct® Java™ System hook, any APEX® System hook, or the Universal Clamp® (titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use.
In order to achieve additional levels of fixation, the Vitality® Spinal Fixation System rods may be connected to the Instinct® Java™ System (Ø5.5mm rod) or the Virage® OCT Spinal Fixation System (Ø3.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct® Java™ System and Virage® OCT Spinal Fixation System package inserts for instructions and indications for use.
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWP, KWO
Device Description
The Vitality® Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred.
The system also includes instrumentation for insertion and removal and securing of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct.
The Vitality® Spinal Fixation System is compatible with the Virage® OCT Spinal Fixation System Rods, Instinct® Java "Spinal Fixation System Rods and Universal Clamp® Spinal Fixation System.
The Vitality®+ Power Instrument System includes instrumentation to be used with power for the preparation of the pedicle and ilium and insertion of Vitality® Spinal Fixation System screws. The system includes reusable Vitality drills, taps, drivers and adapters to be used with an electric handpiece. The subject instruments are compatible for use with the Vitality® Spinal Fixation System implants.
The proposed instruments subject of this submission are intended for exclusive use with Zimmer Biomet Universal Power System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal, T1-S2/ilium, T1-L5, T8-L5, L5-S1 vertebra, lumbosacral spine, L3sacrum/ilium
Indicated Patient Age Range
skeletally mature patients, adolescent patients, pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing was performed to demonstrate that the subject Vitality® Spinal Fixation System with Vitality®+ Power instruments is substantially equivalent to other predicate devices. The following testing and analysis was performed:
- Cadaveric Testing
- Clinical Literature Assessment
The results from the non-clinical testing and analysis show that the subject Vitality® Spinal Fixation System is substantially equivalent to the Vitality® Spinal Fixation System (K171907), Stryker XIA® 4.5 Spinal Fixation System with Power Adapter Instrument Accessory (K152632), and Medtronic CD HORIZON® Spinal System with IPC® Powerease® System (K170679).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, forming a single, abstract shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 27, 2017
Zimmer Biomet Spine, Inc. Ms. Kelly Stratton Regulatory Affairs Specialist 10225 Westmoor Drive Westminster, Colorado 80021
Re: K172275
Trade/Device Name: Vitality® Spinal Fixation System, Vitality®+ Power Instrument System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWO Dated: July 27, 2017 Received: July 28, 2017
Dear Ms. Stratton:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education (DICE) 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. 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 Industry and Consumer Education (DICE) 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.
Ronald P. Jean - S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K172275
Device Name Vitality® Spinal Fixation System
Indications for Use (Describe)
The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/iium), posterior hook fixation (TI-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.
These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scolosis, Scheuermann's Disease), tumor, stenoss, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality Spinal Fixation System is intended to be used with autograft and/or allograft.
In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusionenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.
When used for posterior non-cervical pediatic patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality® System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct Java® System hook, any APEX® System hook, or the Universal Clamp® (titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use.
In order to achieve additional levels of fixation the Vitality® Spinal Fixation System rods may be connected to the Instinct Java® System (05.5mm rod) or the Virage® OCT Spinal Fixation System (03.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct Java® System and Virage® OCT Spinal Fixation System package inserts for instructions for use.
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.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known)
K172275
Device Name Vitality®+ Power Instrument System
Indications for Use (Describe)
Intended Use (Power):
Vitality®+ Power instruments and adapters are intended for use with the Zimmer Biomet Universal Power System to facilitate the preparation of the pedicle and ilium and insertion of Vitality® Spinal Fixation System screws using a power surgical technique. Pedicle and iliac screws from the Vitality® Spinal Fixation System may be implanted in the non-cervical spine using powered instrumentation during spinal surgery, including open and minimally invasive procedures.
Indications for Use (Power):
The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation is indicated for skeletally mature patients and for adolescent patients.
These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scolosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fitality® Spinal Fixation System is intended to be used with autograft and/or allograft.
In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusione graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.
When used for posterior non-cervical pediatic patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scolosis. The Vitality® System is intended to be used with autograft and or allograff. Pediatric pedicle screw fixation is limited to a posterior approach.
Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct Java® System hook, any APEX® System hook, or the Universal Clamp® (titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use.
In order to achieve additional levels of fixation the Vitality® Spinal Fixation System rods may be connected to the Instinct Java® System (05.5mm rod) or the Virage® OCT Spinal Fixation System (03.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct Java® System and Virage® OCT Spinal Fixation System package inserts for instructions for use.
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.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
5
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
6
Image /page/6/Picture/0 description: The image shows the Zimmer Biomet logo, which includes a stylized blue "Z" inside a circle, followed by the text "ZIMMER BIOMET" in a simple, sans-serif font. Below the company name, the text "K172275" is displayed, followed by "Page 1 of 5". This suggests that the image is part of a document or report, possibly related to a medical device or procedure.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date | September 13, 2017 |
|---|---|
| Applicant/Sponsor | Zimmer Biomet Spine, Inc. |
| 10225 Westmoor Dr. | |
| Westminster, CO 80021 | |
| Contact Person | Kelly Stratton |
| Regulatory Affairs Specialist | |
| Phone: 303-501-8386 | |
| Fax: 303-501-8444 | |
| Trade Name | Vitality® Spinal Fixation System, Vitality®+ Power Instrument System |
| Common Name | Pedicle Screw Spinal System |
| Device Class | Class II |
| Classification Name | Thoracolumbosacral Pedicle Screw System (NKB) |
| Class II per 21 CFR §888.3070 | |
| Appliance, Fixation, Spinal Interlaminal (KWP) | |
| Class II per 21 CFR §888.3050 | |
| Appliance, Fixation, Spinal Intervertebral Body (KWQ) | |
| Class II per 21 CFR §888.3060 | |
| Device Panel | Orthopedic |
Device Description & Technological Characteristics:
1. Vitality® Spinal Fixation System
The Vitality® Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred.
The system also includes instrumentation for insertion and removal and securing of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical
7
Image /page/7/Picture/0 description: The image shows the Zimmer Biomet logo, which includes a stylized blue "Z" inside a circle, followed by the text "ZIMMER BIOMET" in gray. Below the logo and text, the text "K172275" is displayed, followed by "Page 2 of 5". The text is in a smaller font size than the company name.
grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct.
The Vitality® Spinal Fixation System is compatible with the Virage® OCT Spinal Fixation System Rods, Instinct® Java "Spinal Fixation System Rods and Universal Clamp® Spinal Fixation System.
2. Vitality®+ Power Instrument System
The Vitality®+ Power Instrument System includes instrumentation to be used with power for the preparation of the pedicle and ilium and insertion of Vitality® Spinal Fixation System screws. The system includes reusable Vitality drills, taps, drivers and adapters to be used with an electric handpiece. The subject instruments are compatible for use with the Vitality® Spinal Fixation System implants.
The proposed instruments subject of this submission are intended for exclusive use with Zimmer Biomet Universal Power System.
Intended Use/ Indications for Use
1. Vitality® Spinal Fixation System
The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.
These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality® Spinal Fixation System is intended to be used with autograft and/or allograft.
In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The Vitality® System is intended to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.
Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct® Java™ System hook, any APEX® System hook, or the Universal Clamp®
8
Image /page/8/Picture/0 description: The image shows the Zimmer Biomet logo, along with the text "K172275 Page 3 of 5". The logo consists of a blue circle with a stylized "Z" inside, followed by the company name in gray. The text below the logo indicates a document identifier and page number.
(titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use.
In order to achieve additional levels of fixation, the Vitality® Spinal Fixation System rods may be connected to the Instinct® Java™ System (Ø5.5mm rod) or the Virage® OCT Spinal Fixation System (Ø3.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct® Java™ System and Virage® OCT Spinal Fixation System package inserts for instructions and indications for use.
2. Vitality®+ Power Instrument System
Intended Use (Power):
Vitality®+ Power instruments and adapters are intended for use with the Zimmer Biomet Universal Power System to facilitate the preparation of the pedicle and ilium and insertion of Vitality Spinal Fixation System screws using a power surgical technique.
Pedicle and iliac screws from the Vitality® Spinal Fixation System may be implanted in the noncervical spine using powered instrumentation during spinal surgery, including open and minimally invasive procedures.
Indications for Use (Power):
The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.
These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality® Spinal Fixation System is intended to be used with autograft and/or allograft.
In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are 13sacrum/ilium.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The
9
Image /page/9/Picture/0 description: The image shows the Zimmer Biomet logo, with the text "ZIMMER BIOMET" in gray. Below the logo, the text "K172275" and "Page 4 of 5" are printed in a smaller font size. The logo consists of a stylized letter Z inside a circle.
Vitality® System is intended to be used with autograft. Pediatric pediale screw fixation is limited to a posterior approach.
Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct® Java™ System hook, any APEX® System hook, or the Universal Clamp® (titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use.
In order to achieve additional levels of fixation, the Vitality® Spinal Fixation System rods may be connected to the Instinct® Java™ System (Ø5.5mm rod) or the Virage® OCT Spinal Fixation System (Ø3.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct® Java™ System and Virage® OCT Spinal Fixation System package inserts for instructions and indications for use.
Summary of Technological Characteristics:
1. Vitality® Spinal Fixation System
The technological characteristics of the subject Vitality® Spinal Fixation System remain the same as, or similar to, the predicate Vitality® Spinal Fixation System (K171907) in regards to intended use, indications for use, design, manufacturing methods, fundamental technology, materials, and operational principles.
2. Vitality®+ Power Instrument System
The subject Vitality®+ Power Spinal Fixation System includes instrumentation to be used with power for the preparation of the pedicle and ilium and insertion of Vitality® Spinal Fixation System screws. The subject system has the same technological characteristics as predicates Vitality® Spinal Fixation System (K171907), Stryker XIA® 4.5 Spinal Fixation System with Power Adapter Instrument Accessory (K152632), and Medtronic CD HORIZON® Spinal System with IPC® Powerease® System (K170679) in terms of design, fundamental technology, materials and manufacturing methods. The performance characteristics and operational principles are substantially equivalent.
Summary of Non-Clinical Testing / Performance Data:
Nonclinical testing was performed to demonstrate that the subject Vitality® Spinal Fixation System with Vitality®+ Power instruments is substantially equivalent to other predicate devices. The following testing and analysis was performed:
- Cadaveric Testing .
- Clinical Literature Assessment
Predicates:
Primary Predicate: Vitality® Spinal Fixation System (K171907) Additional Predicates:
Stryker XIA® 4.5 Spinal Fixation System with Power Adapter Instrument Accessory (K152632)
Medtronic CD HORIZON® Spinal System with IPC® Powerease® System (K170679)
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Substantial Equivalence:
The results from the non-clinical testing and analysis show that the subject Vitality® Spinal Fixation System is substantially equivalent to the Vitality® Spinal Fixation System (K171907), Stryker XIA® 4.5 Spinal Fixation System with Power Adapter Instrument Accessory (K152632), and Medtronic CD HORIZON® Spinal System with IPC® Powerease® System (K170679).
Conclusion:
The Vitality® Spinal Fixation System is substantially equivalent to the predicate system as a spinal fixation device in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles. Furthermore, cadaveric testing and clinical literature assessment sufficiently demonstrate the substantial equivalence of the subject components to the Vitality® Spinal Fixation System, which has been cleared for non-cervical spinal fixation. Based on this information, the subject device does not raise any new issues regarding the safety or efficacy when compared to its predicates.