(172 days)
Not Found
No
The document describes a mechanical spinal fixation system and bone cement, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to be implanted for fixation in the spine due to various conditions like degenerative disc disease, spondylolisthesis, trauma, and curvatures. It is explicitly described as an adjunct to fusion and for temporary internal fixation and stabilization, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The Invictus Spinal Fixation System is a surgical implant designed for fixation and stabilization of the spine, not for diagnosing medical conditions.
No
The device description clearly states it is a "thoracolumbosacral spinal fixation system" consisting of "implants are manufactured from titanium alloy... commercially pure titanium... and cobalt chromium alloy." It also includes "Invictus Bone Cement." These are all physical hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Invictus Spinal Fixation System is a system of implants (screws, hooks, rods, etc.) and bone cement designed for surgical implantation to stabilize the spine.
- Intended Use: The intended use is for spinal fixation as an adjunct to fusion or to restore spinal column integrity in certain cases. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant system, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Invictus Spinal Fixation System is intended for non-cervical posterior and anterolateral fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Invictus Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.
The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.
Invictus Core and Invictus SI.Core Screws are not intended for use with cement; all other fenestrated screws may be used with Invictus Bone Cement. When used in conjunction with Invictus Bone Cement, the Invictus Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Invictus Fenestrated Screws augmented with Invictus Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Product codes
PML, NKB, KWP, KWQ
Device Description
The Invictus Spinal Fixation System is thoracolumbosacral spinal fixation system designed to be implanted through a non-cervical posterior or anterolateral surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine.
Invictus Bone Cement is a self-hardening and ready to use polymethylmethacrylate (PMMA) bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. The cement is made of two sterile components: the polymer in powder and the liquid monomer. The liquid component is mainly composed of methacrylate. The major powder components are polymethylmethacrylate, methyl methacrylate, and zirconium dioxide. Benzoyl peroxide, which initiates polymerization, is included in the polymer powder. The powder and liquid monomer are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box.
The purpose of this submission is to expand indications for use of Invictus fenestrated screws with Invictus Bone Cement, add new fixed fenestrated pedicle screws to the Invictus Spinal Fixation System, and to expand indications of the Invictus Spinal Fixation System for non-cervical anterolateral fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical posterior and anterolateral fixation (thoracic, lumbar and sacral spine)
Indicated Patient Age Range
skeletally mature 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 performed on the subject Invictus Bone Cement, Invictus Spinal Fixation System, supports substantial equivalence to the other predicate devices. The following testing was performed:
- Axial Pullout Strength testing per ASTM F543
- Screw Torque Removal testing per ASTM F543
- Cadaveric testing to evaluate cement flow and bolus formation
The results demonstrate that the subject Invictus Bone Cement, Invictus Spinal Fixation System is substantially equivalent to other predicate devices for nonclinical testing.
Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
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.
K103433, K214006, K200596, K173095, K212692, K180498
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
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
0
December 20, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Alphatec Spine, Inc. Aditya Aiyer Regulatory Affairs Specialist 1950 Camino Vide Roble Carlsbad, California 92008
Re: K221926
Trade/Device Name: Invictus® Bone Cement, Invictus Spinal Fixation System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: PML, NKB, KWP, KWQ Dated: November 29, 2022 Received: November 30, 2022
Dear Aditya Aiyer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Anne D. Talley -S for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221926
Device Name
Invictus® Bone Cement, Invictus Spinal Fixation System
Indications for Use (Describe)
The Invictus Spinal Fixation System is intended for non-cervical posterior and anterolateral fixation in skeletally mature patients as an adjunct to following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. Fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis); tumor; pseudarthrosis; and or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Invictus System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatic pedicle screw fixation is limited to a posterior approach.
The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.
Invictus Core and Invictus SI.Core Screws are not intended for use with cement; all other fenestrated screws may be used with Invictus Bone Cement. When used in conjunction with Invictus Bone Cement, the Invictus Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Invictus Fenestrated Screws augmented with Invictus Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the logo for "atec". The "a" is green, and the "tec" is dark blue. There is a trademark symbol to the right of the "c". There is a black line underneath the logo.
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| I. | SUBMITTER: | Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad, CA 92008
Phone: (760) 431-9286
Fax: (760) 431-0289 | |
|-----|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Contact Person: | Aditya Aiyer
Regulatory Affairs Specialist
Contact Phone: (760) 494-6671 | |
| | Date Summary Prepared: | December 19, 2022 | |
| II. | DEVICE | | |
| | Name of Device: | Invictus® Bone Cement, Invictus Spinal Fixation
System | |
| | Common or Usual Name: | Bone cement, Thoracolumbosacral pedicle screw
system, Spinal Interlaminal Fixation System, Spinal
Intervertebral Body Fixation System | |
| | Classification Name: | Polymethylmethacrylate (PMMA) Bone Cement (21
CFR 888.3027) Thoracolumbosacral Pedicle Screw
System (21 CFR 888.3070) Spinal Interlaminal
Fixation Orthosis (21 CFR 888.3050) Spinal
Intervertebral Body Fixation Orthosis (21
CFR 888.3060) | |
| | Regulatory Class: | Class II | |
| | Product Code: | PML, NKB, KWP, KWO | |
III. LEGALLY MARKETED PREDICATE DEVICES
| 510(k) | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K103433 | NDN | F20 | Teknimed |
| Additional Predicate Devices | |||
| K214006 | NKB, KWP | Invictus® Spinal Fixation System | Alphatec Spine |
| K200596 | PML, NKB | G21 Cement, VADER Pedicle System | Icotec AG |
| K173095 | NKB, KWP, | ||
| KWQ | VIPER PRIME™ Screws, VIPER | ||
| PRIME™ Screws with Fenestrations, | |||
| EXPEDIUM® Verse Screws with | |||
| Fenestrations | DePuy Synthes |
4
Image /page/4/Picture/0 description: The image shows the logo for "atec". The "a" is green and the "tec" is dark blue. There is a horizontal line underneath the logo.
| 510(k) | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K212692 | NKB, KWQ, | ||
| KWP | Mariner Pedicle Screw System | SeaSpine | |
| K180498 | PML, NKB, | ||
| KWP | High V+ Bone Cement, NuVasive® | ||
| Reline® Fenestrated Screws | NuVasive |
IV. DEVICE DESCRIPTION
The Invictus Spinal Fixation System is thoracolumbosacral spinal fixation system designed to be implanted through a non-cervical posterior or anterolateral surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine.
Invictus Bone Cement is a self-hardening and ready to use polymethylmethacrylate (PMMA) bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. The cement is made of two sterile components: the polymer in powder and the liquid monomer. The liquid component is mainly composed of methacrylate. The major powder components are polymethylmethacrylate, methyl methacrylate, and zirconium dioxide. Benzoyl peroxide, which initiates polymerization, is included in the polymer powder. The powder and liquid monomer are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box.
The purpose of this submission is to expand indications for use of Invictus fenestrated screws with Invictus Bone Cement, add new fixed fenestrated pedicle screws to the Invictus Spinal Fixation System, and to expand indications of the Invictus Spinal Fixation System for non-cervical anterolateral fixation.
V. INDICATIONS FOR USE
The Invictus Spinal Fixation System is intended for non-cervical posterior and anterolateral fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Invictus Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus
5
Image /page/5/Picture/0 description: The image shows the logo for "atec". The "a" is green, while the "tec" is dark blue. There is a horizontal line underneath the logo. The letters are stylized and connected.
Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.
The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.
Invictus Core and Invictus SI.Core Screws are not intended for use with cement; all other fenestrated screws may be used with Invictus Bone Cement. When used in conjunction with Invictus Bone Cement, the Invictus Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Invictus Fenestrated Screws augmented with Invictus Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
VI. TECHNOLOGICAL COMPARISON TO PREDICATES
The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent.
VII. PERFORMANCE DATA
Nonclinical testing performed on the subject Invictus Bone Cement, Invictus Spinal Fixation System, supports substantial equivalence to the other predicate devices. The following testing was performed:
- Axial Pullout Strength testing per ASTM F543 ●
- Screw Torque Removal testing per ASTM F543 ●
- Cadaveric testing to evaluate cement flow and bolus formation ●
The results demonstrate that the subject Invictus Bone Cement, Invictus Spinal Fixation System is substantially equivalent to other predicate devices for nonclinical testing.
Clinical Information
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
VIII. CONCLUSION
Based upon the information provided in this 510(k) submission it has been determined that the subject devices are substantially equivalent to legally marketed devices in regard to indications for use, intended use, design, technology, and performance.