(23 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system consisting of rods, screws, hooks, and connectors. There is no mention of software, algorithms, image processing, AI, DNN, or ML. The performance studies are mechanical tests, not studies of algorithmic performance.
No.
The device is described as a spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion, rather than a treatment itself. It's an implantable device used to support the spine, not a therapeutic agent or method for treating a disease directly.
No
This device is a spinal fixation system, intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of physical components like rods, screws, hooks, connectors, and cross connectors made of surgical grade materials, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Invictus® Small Stature Spinal Fixation System is a surgical implant intended for the mechanical stabilization and fixation of the spine during fusion. It is a physical device implanted in the body, not used to test samples outside the body.
The description clearly indicates it's a system of rods, screws, hooks, and connectors used in surgical procedures to provide internal fixation and stabilization. This falls under the category of surgical implants or orthopedic devices, not IVDs.
N/A
Intended Use / Indications for Use
The Invictus® Small Stature Spinal Fixation System is intended for non-cervical posterior and anterolateral fixation in skeletally mature patients as an adjunct to 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 screw fixation in pediatric patients, the Invictus® Small Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus® Small Stature 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® Small Stature Spinal Fixation System is intended to be used with autograft and/or allograft.
Product codes
NKB, KWQ, KWP
Device Description
The Invictus® Small Stature Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The Invictus® Small Stature Spinal Fixation system is compatible with Arsenal® Spinal Fixation System and Invictus® Spinal Fixation System offered by Alphatec Spine using various rod-to-rod connectors and/or transitional rods. The Invictus® Small Stature Spinal Fixation System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and cross connectors that provide internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and cross connectors are manufactured from surgical grade titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The rods are available in commercially pure titanium (CP Ti Grade 4) per ASTM F67, titanium alloy (Ti-6A1-4V ELI) per ASTM F136, and cobalt chrome (Co-28Cr-6Mo) per ASTM F1537.
The Invictus® Small Stature implants are provided non-sterile to be steam sterilized by the end user. The instruments are made of stainless steel and other materials and are provided non-sterile to be cleaned and sterilized by the end user. The instruments in this system are intended for use in surgical procedures.
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 in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
When used for posterior non-cervical screw fixation in pediatric patients.
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)
The following non-clinical testing was performed and included, where appropriate for the design, or referenced in predicate 510(k) submissions to support clearance of Invictus Small Stature Spinal Fixation System:
- ASTM F1717 Static Compression Bending ●
- ASTM F1717 Dynamic Compression Bending
- ASTM F1798 Static A-P Tulip Pull-off (Fx) Straight ●
- ASTM F1798 Static A-P Tulip Pull-off (Fx) – Angled
- F1798 Static Flexion-Extension (My) Bottom-loading, Straight ●
- F1798 Static Flexion-Extension (My) Bottom-loading, Angled ●
The results demonstrate that the subject Invictus Small Stature Spinal Fixation System is substantially equivalent to other predicate devices for nonclinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K232275, K223181, K161363, K113395, K181390, K192938
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
June 21, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Alphatec Spine, Inc. Andrew Zhang Regulatory Affairs Specialist 1950 Camino Vida Roble Carlsbad, California 92008
Re: K241519
Trade/Device Name: Invictus® Small Stature Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWQ, KWP Dated: May 24, 2024 Received: May 29, 2024
Dear Andrew Zhang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Colin O'neill -S
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
2
Indications for Use
510(k) Number (if known) K241519
Device Name
Invictus® Small Stature Spinal Fixation System
Indications for Use (Describe)
The Invictus® Small Stature Spinal Fixation System is intended for non-cervical posterior and anterolateral fixation in skeletally mature patients as an adjunct to 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 screw fixation in pediatric patients, the Invictus® Small Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus® Small Stature 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® Small Stature Spinal Fixation System is intended to be used with autograft and/or allograft.
| 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
This 510(k) summary 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) 494-6860
Fax: (760) 431-0289 |
|----|------------------------|----------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Andrew Zhang
Regulatory Affairs Specialist
Contact Phone: (760) 494-6860 |
| | Date Summary Prepared: | June 21, 2024 |
II. DEVICE
| Trade or Proprietary Name: | Invictus® Small Stature Spinal Fixation System |
|---|---|
| Common Name: | Pedicle Screw System |
| Classification Name: | Thoracolumbosacral Pedicle Screw System, Spinal |
| Interlaminal Fixation Orthosis, Spinal Intervertebral Body | |
| Fixation Orthosis | |
| Regulation Number: | 21 CFR 888.3070, 888.3050, 888.3060 |
| Classification: | Class II |
| Product Code: | NKB, KWP, KWQ |
III. LEGALLY MARKETED PREDICATE DEVICES
| Primary Predicate Device: | |||
|---|---|---|---|
| 510(k) | Product Name | Product Code | Clearance Date |
| K232275 | Invictus® Spinal Fixation System | NKB, KWP, KWQ, PML, OUR | September 27, 2023 |
Additional Predicate Devices:
| 510(k) | Product Name | Product Code | Clearance Date |
|---|---|---|---|
| K223181 | NuVasive Reline System | NKB, KWP, KWQ | January 11, 2023 |
| K161363 | Arsenal™ Spinal Fixation System | NKB, OSH, MNI, MNH, KWP | June 10, 2016 |
| K113395 | REVERE 4.5 Stabilization System | MNH, MNI, KWQ, KWP, NKB, OSH | June 14, 2012 |
| K181390 | Response Spine System, Response | ||
| 5.5/6.0 Spine System, Response | |||
| 4.5/5.0 Spine System | NKB, KWP | September 18, 2018 | |
| K192938 | Invictus® Spinal Fixation System | NKB, KWP | December 12, 2019 |
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DEVICE DESCRIPTION IV.
The Invictus® Small Stature Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The Invictus® Small Stature Spinal Fixation system is compatible with Arsenal® Spinal Fixation System and Invictus® Spinal Fixation System offered by Alphatec Spine using various rod-to-rod connectors and/or transitional rods. The Invictus® Small Stature Spinal Fixation System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and cross connectors that provide internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and cross connectors are manufactured from surgical grade titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The rods are available in commercially pure titanium (CP Ti Grade 4) per ASTM F67, titanium alloy (Ti-6A1-4V ELI) per ASTM F136, and cobalt chrome (Co-28Cr-6Mo) per ASTM F1537.
The Invictus® Small Stature implants are provided non-sterile to be steam sterilized by the end user. The instruments are made of stainless steel and other materials and are provided non-sterile to be cleaned and sterilized by the end user. The instruments in this system are intended for use in surgical procedures.
V. INDICATIONS FOR USE
The Invictus® Small Stature 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 screw fixation in pediatric patients, the Invictus® Small Stature 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 Invictuse Small Stature 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® Small Stature Spinal Fixation System is intended to be used with autograft and/or allograft.
VI. TECHNOLOGICAL COMPARISON TO PREDICATES
The technological design features of the subject Invictus Small Station System is substantially equivalent to the primary predicate Invictus Spinal Fixation System
5
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(K232275), and additional predicates NuVasive Reline System (K223181) and Arsenal Spinal Fixation System (K152968).
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
The following non-clinical testing was performed and included, where appropriate for the design, or referenced in predicate 510(k) submissions to support clearance of Invictus Small Stature Spinal Fixation System:
- ASTM F1717 Static Compression Bending ●
- ASTM F1717 Dynamic Compression Bending
- ASTM F1798 Static A-P Tulip Pull-off (Fx) Straight ●
- ASTM F1798 Static A-P Tulip Pull-off (Fx) – Angled
- F1798 Static Flexion-Extension (My) Bottom-loading, Straight ●
- F1798 Static Flexion-Extension (My) Bottom-loading, Angled ●
The results demonstrate that the subject Invictus Small Stature Spinal Fixation System is substantially equivalent to other predicate devices for nonclinical testing.
VII. CONCLUSION
Based upon the information provided in this 510(k) submission, it has been determined that the subject device is substantially equivalent to legally marketed devices in regard to indications for use, intended use, design, technology, and performance.