Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
Applicant
Alphatec Spine, Inc.
Product Code
NKB · Orthopedic
Decision Date
Jul 14, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3070
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
The Invictus Small Stature Spinal Fixation System and Invictus 2.0 Spinal Fixation System are 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 and Invictus 2.0 Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Small Stature Spinal Fixation System and Invictus 2.0 Spinal Fixation System are 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 and Invictus 2.0 Spinal Fixation System are intended to be used with autograft and/or allograft. Invictus Small Stature/Invictus 2.0 SI.CORE Screws are intended to be used with Alphatec's 4.5, 5.0, 5.5 and 6.0 mm diameter rods for sacroiliac joint fusion for the following conditions: Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. Invictus Small Stature/Invictus 2.0 CORE and Invictus Small Stature/Invictus 2.0 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 Small Stature/Invictus 2.0 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 Small Stature/Invictus 2.0 Fenestrated Screws augmented with Invictus Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. Invictus 2.0 Navigation Instruments (for Use with StealthStationTM) The Invictus 2.0 Navigation Instruments are intended to be used during the placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Navigation instruments are specifically designed for use with the Medtronic® StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Device Story
System provides spinal segment immobilization/stabilization via rods, screws, hooks, and connectors; used as adjunct to fusion. Implants manufactured from titanium alloy, CP titanium, cobalt chrome, and Molybdenum-Rhenium alloy. Fenestrated screws compatible with PMMA bone cement for tumor-related spinal integrity restoration. Navigation instruments facilitate precise screw placement during open or minimally invasive surgery by interfacing with Medtronic StealthStation surgical navigation system. Surgeon uses navigation to map anatomical structures relative to CT/MR models or fluoroscopy. System provides rigid construct to support bone graft healing. Non-sterile; requires steam sterilization by end-user.
Indicated for skeletally mature and pediatric patients requiring non-cervical posterior/anterolateral spinal fixation as an adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, and failed fusion. Pediatric use limited to posterior approach for progressive deformities or specific conditions. Also indicated for sacroiliac joint fusion and sacropelvic fixation. Fenestrated screws with bone cement indicated for advanced stage tumors where fusion is not achievable. Navigation instruments indicated for use with StealthStation for stereotactic spinal surgery.
Regulatory Classification
Identification
(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
Special Controls
*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
Medtronic Navigated Manual Reusable Instruments for use with the StealthStation™ (K161210)
Valence Robotic Navigation Instruments (for use with StealthStation) (K252597)
Submission Summary (Full Text)
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**FDA U.S. FOOD & DRUG**
ADMINISTRATION
July 14, 2026
Alphatec Spine, Inc.
Andrew Zhang
Regulatory Affairs Specialist
1950 Camino Vida Roble
Carlsbad, California 92084
Re: K261284
Trade/Device Name: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
Regulation Number: 21 CFR 888.3070
Regulation Name: Thoracolumbosacral Pedicle Screw System
Regulatory Class: Class II
Product Code: NKB, KWP, KWQ, PML, OUR, OLO
Dated: April 17, 2026
Received: April 17, 2026
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K261284 - Andrew Zhang
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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).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K261284 - Andrew Zhang
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assistance/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, 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
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261284 | ? |
| Please provide the device trade name(s). | | ? |
| Invictus® Small Stature Spinal Fixation System;Invictus® 2.0 Spinal Fixation System | | |
| Please provide your Indications for Use below. | | ? |
| Invictus Small Stature Spinal Fixation System and Invictus 2.0 Spinal Fixation SystemThe Invictus Small Stature Spinal Fixation System and Invictus 2.0 Spinal Fixation System are 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 and Invictus 2.0 Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Small Stature Spinal Fixation System and Invictus 2.0 Spinal Fixation System are 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 and Invictus 2.0 Spinal Fixation System are intended to be used with autograft and/or allograft.Invictus Small Stature/Invictus 2.0 SI.CORE Screws are intended to be used with Alphatec's 4.5, 5.0, 5.5 and 6.0 mm diameter rods for sacroiliac joint fusion for the following conditions:Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.Invictus Small Stature/Invictus 2.0 CORE and Invictus Small Stature/Invictus 2.0 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 Small Stature/Invictus 2.0 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 Small Stature/Invictus 2.0 Fenestrated Screws augmented with Invictus Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.Invictus 2.0 Navigation Instruments (for Use with StealthStationTM)The Invictus 2.0 Navigation Instruments are intended to be used during the placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or | | |
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minimally invasive, procedures.
Navigation instruments are specifically designed for use with the Medtronic® StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| --- | --- | --- |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☐ Adults (22 years old and greater) | ? |
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atec™
K261284 - Page 1 of 6
Traditional 510(k) Premarket Notification
Invictus® Small Stature and Invictus® 2.0 Spinal Fixation Systems
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) 494-6860
Fax: (760) 431-0289
Contact Person:
Andrew Zhang
Regulatory Affairs Specialist
Contact Phone: (760) 494-6860
Date Summary Prepared:
April 16, 2026
# II. DEVICE
Trade or Proprietary Name: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
Common Name: Pedicle Screw System
Classification Name: Thoracolumbosacral Pedicle Screw System
Spinal Interlaminal Fixation Orthosis
Spinal Intervertebral Body Fixation Orthosis
Polymethylmethacrylate (PMMA) bone cement
Spinal Intervertebral Body Fixation Orthosis
Stereotaxic Instrument
Regulation Number: 21 CFR 888.3070, 21 CFR 888.3050, 21 CFR 888.3060,
21 CFR 888.3027, 21 CFR 888.3040, 21 CFR 882.4560
Classification: Class II
Product Code: NKB, KWP, KWQ, PML, OUR, OLO
# 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 |
| --- | --- | --- | --- |
| K241519 | Invictus® Small Stature Spinal Fixation System | NKB, KWP, KWQ | June 21, 2024 |
| K180337 | EUROPA™ Pedicle Screw System | NKB | March 14, 2019 |
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atec™
K261284 - Page 2 of 6
Traditional 510(k) Premarket Notification
Invictus® Small Stature and Invictus® 2.0 Spinal Fixation Systems
| K161210 | Medtronic Navigated Manual Reusable Instruments for use with the StealthStation™ | OUR, HWE, OLO | August 12, 2016 |
| --- | --- | --- | --- |
| K252597 | Valence Robotic Navigation Instruments (for use with StealthStation) | OLO | February 19, 2026 |
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atec™
K261284 - Page 3 of 6
Traditional 510(k) Premarket Notification
Invictus® Small Stature and Invictus® 2.0 Spinal Fixation Systems
# IV. DEVICE DESCRIPTION
The Invictus Small Stature Spinal Fixation System and Invictus 2.0 Spinal Fixation System are 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 and Invictus 2.0 Spinal Fixation System are compatible with the Invictus Spinal Fixation System and Arsenal Spinal Fixation System offered by Alphatec Spine using various rod-to-rod connectors and/or transitional rods. The Invictus Small Stature Spinal Fixation system and Invictus 2.0 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-6Al-4V ELI) per ASTM F136, cobalt chrome (Co-28Cr-6Mo) per ASTM F1537, and Molybdenum-47.5Rhenium alloy per ASTM F3273-17.
Invictus Small Stature/Invictus 2.0 SI.CORE bone screws are intended to provide sacroiliac joint fusion in sacral alar iliac (SAI) trajectories. Invictus Small Stature/Invictus 2.0 CORE and Invictus Small Stature/Invictus 2.0 SI.CORE Screws are not intended for use with cement; all other fenestrated screws may be used with Invictus Bone Cement, a self-hardening and ready to use polymethylmethacrylate (PMMA) bone cement with a high amount of radiopaque agent.
The Invictus Small Stature Patient Specific Rods are used to connect pedicle screws, hooks, and connectors across different levels of vertebral bodies to create a rigid construct. They are intended to be used with standard Invictus Small Stature instrumentation. The Invictus Small Stature Patient Specific Rods are available in Ø4.5 mm and 5.0 mm diameters and will be provided in lengths between 20 - 600 mm. Equivalent to cleared Invictus Small Stature rod materials, the rods are made from: commercially pure titanium (CP Ti Grade 4) per ASTM F67, titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and cobalt chrome (Co-28Cr-6Mo) per ASTM F1537. All Invictus Small Stature Patient Specific Rods are provided pre-contoured to the surgeon's plan based on the patient's anatomy by means of an industrial bending process prior to distribution for surgery.
The Invictus 2.0 Navigation Instruments (for use with StealthStation™) are designed to be compatible with the Medtronic® StealthStation™ Surgical Navigation System. The navigated instruments are intended to be used during the placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures.
The Invictus Small Stature and Invictus 2.0 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.
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atec™
K261284 - Page 4 of 6
Traditional 510(k) Premarket Notification
Invictus® Small Stature and Invictus® 2.0 Spinal Fixation Systems
# V. INDICATIONS FOR USE
# Invictus Small Stature Spinal Fixation System and Invictus 2.0 Spinal Fixation System
The Invictus Small Stature Spinal Fixation System and Invictus 2.0 Spinal Fixation System are 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 and Invictus 2.0 Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Small Stature Spinal Fixation System and Invictus 2.0 Spinal Fixation System are 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 and Invictus 2.0 Spinal Fixation System are intended to be used with autograft and/or allograft.
Invictus Small Stature/Invictus 2.0 SI.CORE Screws are intended to be used with Alphatec's 4.5, 5.0, 5.5 and 6.0 mm diameter rods for sacroiliac joint fusion for the following conditions:
- Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
- To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
- Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
Invictus Small Stature/Invictus 2.0 CORE and Invictus Small Stature/Invictus 2.0 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 Small Stature and Invictus 2.0 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 Small Stature and Invictus 2.0 Fenestrated Screws augmented with Invictus Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
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atec™
K261284 - Page 5 of 6
Traditional 510(k) Premarket Notification
Invictus® Small Stature and Invictus® 2.0 Spinal Fixation Systems
### Invictus 2.0 Navigation Instruments (for Use with StealthStation™)
The Invictus 2.0 Navigation Instruments are intended to be used during the placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures.
Navigation instruments are specifically designed for use with the Medtronic® StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
### VI. TECHNOLOGICAL COMPARISON TO PREDICATES
The technological design features of the subject Invictus Small Stature Spinal Fixation System and Invictus 2.0 Spinal Fixation System are substantially equivalent to the primary predicate Invictus Spinal Fixation System (K232275), and additional predicates Invictus Small Stature Spinal Fixation System (K241519), EUROPA Pedicle Screw System (K180337), Medtronic Navigated Manual Reusable Instruments for use with the StealthStation (K161210) and Valence Robotic Navigation Instruments (for use with StealthStation) (K252597).
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 and Invictus 2.0 Spinal Fixation System:
- ASTM F1717 Static Compression Bending
- ASTM F1717 Dynamic Compression Bending
- ASTM F1798 Static A-P Tulip Pull-off (Fx) – Straight and Angled Shank Orientations
- ASTM F1798 Axial Gripping Capacity (Fz)
- ASTM F1877 Particulate Analysis
- ASTM F2129 Pitting Corrosion
- ASTM F3044 Galvanic Corrosion
- ASTM F1798 Static Flexion-Extension (My) – Straight and Angled Shank Orientations
- ASTM F1798 Dynamic Flexion-Extension (My)
- Dimensional Analysis of the Invictus 2.0 Navigation Instruments for Use with StealthStation compared to Medtronic instruments
The results demonstrate that the subject Invictus Small Stature Spinal Fixation System and Invictus 2.0 Spinal Fixation System are substantially equivalent to other predicate devices for nonclinical testing.
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K261284 - Page 6 of 6
Traditional 510(k) Premarket Notification
Invictus® Small Stature and Invictus® 2.0 Spinal Fixation Systems
### VIII. 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.
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
