(160 days)
Not Found
No
The document describes a spinal fixation system and navigated instruments for surgical guidance. It mentions using imaging modalities (CT, MR, fluoroscopy) and a navigation system (Medtronic StealthStation® System) to assist the surgeon in locating anatomical structures. There is no mention of AI, ML, or any algorithms that would process data to make decisions, predictions, or classifications beyond basic navigation and visualization. The performance studies are non-clinical mechanical tests, not studies evaluating algorithmic performance.
Yes
The device is described as a "spinal fixation system" intended for "immobilization and stabilization of the posterior, non-cervical spine as an adjunct to fusion" and for "temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures." These functions directly treat or alleviate a disease or injury, which aligns with the definition of a therapeutic device.
No
The device is described as a "Modular Spinal Fixation System" and "Navigated Instrument System" intended for immobilization and stabilization of the posterior, non-cervical spine as an adjunct to fusion, and to assist the surgeon in precisely locating anatomical structures during spinal surgery. Its primary function is surgical assistance and stabilization, not to diagnose a medical condition.
No
The device description clearly outlines a system composed of physical implants (screws, rods, bands, etc.) and instruments for their installation. While it mentions a "Navigated Instrument System" that uses software (Medtronic StealthStation® System) for guidance, the core device being described is a hardware-based spinal fixation system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Description and Intended Use: The description and intended use clearly state that this system is a spinal fixation system used for immobilization and stabilization of the spine during surgical procedures. It involves implants and instruments used directly on the patient's anatomy.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any specimens from the human body for diagnostic purposes. The system is used for surgical intervention and stabilization.
Therefore, the MASADA Modular Spinal Fixation System, including its navigated instruments and sublaminar band system, falls under the category of surgical implants and instruments, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine 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, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediative patients, the MASADA pedicle screw implants are indicated as an adjunct to fusion to treat adolessent idiopathic scoliosis. The MASADA pedicle screw is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medronic 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.
Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar or facet wiring techniques.
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions.
The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWP, OWI, OLO
Device Description
The MASADA Modular Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system designed to provide fixation during the fusion process. The system is composed of modular polyaxial screws, monoaxial screws, rods, cross connectors, rod connectors, sublaminar band cerclages, band connectors, and hooks. The system is supported by a comprehensive set of instruments to install the implants within the system. All implant components are manufactured from the materials listed in the table below.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
posterior, non-cervical spine, skull, a long bone, or vertebra
Indicated Patient Age Range
Skeletally mature patients, pediatric patients (adolescent idiopathic scoliosis), patients 8 years of age or older (idiopathic and neuromuscular scoliosis)
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)
Non-clinical Test Summary: The following analyses were conducted: Static Compression Bending - ASTM F1717, Dynamic Compression Bending - ASTM F1717, Static Torsion - ASTM F1717, Tulip Dissociation – ASTM F1798.
The results of these evaluations indicate that the MASADA system is substantially equivalent to the predicate devices.
Clinical Test Summary: No clinical studies were performed.
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.
K181139, K172166, K222097, K124058
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.
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November 16, 2023
Image /page/0/Picture/1 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Astura Medical Parker Kelch Quality Manager 4949 W Royal Ln. Irving, Texas 75063
Re: K231694
Trade/Device Name: MASADA Modular Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB. KWP. OWI. OLO Dated: October 17, 2023 Received: October 17, 2023
Dear Parker Kelch:
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).
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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,
Eileen
Digitally signed
by Eileen Cadel -
S
Cadel -S Date: 2023.11.16
10:44:10 -05'00'
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
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Indications for Use
510(k) Number (if known) K231694
Device Name MASADA Modular Spinal Fixation System
Indications for Use (Describe)
Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine 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, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediative patients, the MASADA pedicle screw implants are indicated as an adjunct to fusion to treat adolessent idiopathic scoliosis. The MASADA pedicle screw is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medronic 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.
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) |
|---|---|
| --------------------------------------------------------------------------- | -------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.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."
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Indications for Use
510(k) Number (if known) K231694
Device Name
MASADA Modular Spinal Fixation System
Indications for Use (Describe)
Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
-
Spinal trauma surgery, used in sublaminar or facet wiring techniques.
-
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions.
The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
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510(k) Summary: MASADA Modular Spinal Fixation System
| Date Prepared | June 9th, 2023 |
|---|---|
| Submitted By | Astura Medical |
| 4949 W Royal Ln. | |
| Irving, TX 75063 | |
| Phone: 469-501-5530 | |
| Contact | Parker Kelch |
| 4949 W Royal Ln. | |
| Irving, TX 75063 | |
| Phone: 469-501-5530 x503 | |
| Email: parker@asturamedical.com | |
| Trade Name | MASADA Modular Spinal Fixation System |
| Common Name | Posterior spinal fixation system |
| Classification Name | Thoracolumbosacral pedicle screw system |
| Spinal interlaminal fixation orthosis | |
| Bone fixation cerclage | |
| Orthopedic stereotaxic instrument | |
| Class | II |
| Product Code | NKB, KWP, OWI, OLO |
| CFR Section | 21 CFR section 888.3070, 888.3050, 888.3010, 882.4560 |
| Device Panel | Orthopedic |
| Primary Predicate Device | OLYMPIC Posterior Spinal Fixation System (K181139) |
| Additional Predicate | OLYMPIC Navigated Instruments (K172166) |
| Device(s) | OLYMPIC Deformity Band System (K222097) |
| Globus CREO Stabilization System (K124058) | |
| Device Description | The MASADA Modular Spinal Fixation System is a top loading |
| thoracolumbar, sacral, and iliac fixation system designed to provide | |
| fixation during the fusion process. The system is composed of modular | |
| polyaxial screws, monoaxial screws, rods, cross connectors, rod | |
| connectors, sublaminar band cerclages, band connectors, and hooks. The | |
| system is supported by a comprehensive set of instruments to install the | |
| implants within the system. All implant components are manufactured | |
| from the materials listed in the table below. | |
| Materials | Ti-6Al-4V ELI (ASTM F136) |
| CP Titanium Grade 4 (ASTM F67) | |
| CoCrMo alloy (ASTM F1537) | |
| Elgiloy CoCrNi alloy (ASTM F1058) | |
| Nitinol #1 (ASTM F2063) | |
| PET (ISO 10993) | |
| Substantial Equivalence | The MASADA system is substantially equivalent to the predicate devices |
| Claimed to Predicate | in terms of intended use, design, materials used, mechanical safety and |
| Devices | performances. |
| Indications for Use | Pedicle Screw System: The MASADA Modular Spinal Fixation System |
| is intended for immobilization and stabilization of the posterior, non- | |
| cervical spine 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, or | |
| lordosis), tumor, pseudoarthrosis, and/or failed previous fusion. | |
| When used for posterior non-cervical pedicle screw fixation in pediatric | |
| patients, the MASADA pedicle screw implants are indicated as an adjunct | |
| to fusion to treat adolescent idiopathic scoliosis. The MASADA pedicle | |
| screw is intended to be used with autograft and/or allograft. Pediatric | |
| pedicle screw fixation is limited to a posterior approach. | |
| Sublaminar Band System: The MASADA sublaminar band is a | |
| temporary implant for use in orthopedic surgery. The band system is | |
| intended to provide temporary stabilization as a bone anchor during the | |
| development of solid bony fusion and aid in the repair of bone fractures. | |
| The indications for use include the following applications: | |
| -Spinal trauma surgery, used in sublaminar or facet wiring techniques. | |
| -Spinal reconstructive surgery, incorporated into constructs for the | |
| purpose of correction of spinal deformities such as idiopathic and | |
| neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, | |
| kyphosis and spondylolisthesis. | |
| -Spinal degenerative surgery, as an adjunct to spinal fusions. | |
| The MASADA sublaminar band may also be used in conjunction with | |
| other medical grade implants made of similar metals whenever "wiring" | |
| may help secure the attachment of the other implants. | |
| Navigated Instrument System: The MASADA navigated instruments | |
| are intended to be used in the preparation and placement of MASADA | |
| screws during spinal surgery to assist the surgeon in precisely locating | |
| anatomical structures in either open or minimally invasive procedures. | |
| These instruments are 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 a skull, a long bone, or | |
| vertebra, can be identified relative to a CT or MR based model, | |
| fluoroscopy images, or digitized landmarks of the anatomy. Refer to the | |
| Astura Navigated Instrument system Instructions For Use (INS-00006) | |
| regarding the use of these instruments. | |
| Non-clinical Test | The following analyses were conducted: |
| Summary | ● Static Compression Bending - ASTM F1717 |
| ● Dynamic Compression Bending - ASTM F1717 | |
| Static Torsion - ASTM F1717 Tulip Dissociation – ASTM F1798 | |
| The results of these evaluations indicate that the MASADA system is | |
| substantially equivalent to the predicate devices. | |
| Clinical Test Summary | No clinical studies were performed. |
| Conclusions: Non-Clinical | |
| and Clinical | Astura Medical considers MASADA Modular Spinal Fixation System to be |
| substantially equivalent to the predicate devices listed above. This | |
| conclusion is based upon the devices' similarities in principles of | |
| operation, technology, materials and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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