(84 days)
Not Found
No
The summary describes a mechanical spinal fixation system and navigated instruments used with a separate navigation system. There is no mention of AI or ML in the device description, intended use, or performance studies. The navigation system relies on pre-existing imaging data or digitized landmarks, not AI/ML processing.
Yes
The device is described as a "Spinal Fixation System" intended for "immobilization and stabilization of the posterior, non-cervical spine" and as an "adjunct to fusion" for various medical conditions like "degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and/or failed previous fusion." These are all therapeutic applications.
No
The descriptions of the Pedicle Screw System, Navigated Instrument System, and Sublaminar Band System indicate that they are used for immobilization, stabilization, and placement during surgery, not for diagnosing a condition. The navigated instruments assist in precisely locating anatomical structures, which is a surgical aid, not a diagnostic function.
No
The device description explicitly states the system is composed of physical components like screws, rods, and instruments, and the intended use involves surgical implantation. While it mentions a navigated instrument system that uses software (Medtronic StealthStation® System), the overall device is a physical 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this system is for the immobilization and stabilization of the spine using implants (screws, rods, bands, etc.) and instruments for surgical procedures. This is an in vivo application, meaning it is used within the living body.
- No Mention of Samples or Testing: There is no mention of analyzing biological samples or performing diagnostic tests on them.
- Focus on Surgical Intervention: The entire description revolves around surgical procedures, implant placement, and navigation during surgery.
Therefore, the MASADA Modular Spinal Fixation System is a surgical device, not an in vitro diagnostic device.
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 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.
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
NKB, KWP, OWI, OLO
Device Description
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.
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, or digitized landmarks
Anatomical Site
posterior, non-cervical spine
Indicated Patient Age Range
skeletally mature patients, adolescent (for idiopathic scoliosis), 8 years of age or older (for scoliosis correction with sublaminar band system)
Intended User / Care Setting
surgeon, spinal surgery
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: An engineering analysis determined that no new worst case conditions have been introduced since the previously cleared submission (K231694).
Clinical test summary: No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MASADA Modular Spinal Fixation System (K231694), OLYMPIC MIS (K182239), OLYMPIC Navigated Instruments (K172166), Globus CREO Stabilization System (K124058)
Reference Device(s)
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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January 7, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Astura Medical Parker Kelch Quality and Regulatory Manager 4949 W Royal Ln Irving, Texas 75063
Re: K243259
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 11, 2024 Received: October 15, 2024
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 OS 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.
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-device-advicecomprehensive-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-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).
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Sincerely,
Image /page/2/Picture/3 description: The image contains the text "Colin O'neill -S FDA". The text is arranged in two lines, with "Colin" on the first line and "O'neill -S" on the second line. The letters "FDA" are in a larger font and a lighter color, and they are positioned to the right of the other text.
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) K243259
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 pediale 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.
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.
| 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.
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510(k) Summary: MASADA Modular Spinal Fixation System
| Date Prepared | January 6, 2025 |
|---|---|
| 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 | |
| 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 | MASADA Modular Spinal Fixation System (K231694) |
| Additional Predicate | |
| Device(s) | OLYMPIC MIS (K182239) |
| OLYMPIC Navigated Instruments (K172166) | |
| Globus CREO Stabilization System (K124058) | |
| Device Description | 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. | |
| 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 | |
| Claimed to Predicate | |
| Devices | The MASADA system is substantially equivalent to the predicate devices |
| in terms of intended use, design, materials used, mechanical safety and | |
| 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. | |
| 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. | |
| 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. | |
| Non-clinical Test | |
| Summary | An engineering analysis determined that no new worst case conditions |
| have been introduced since the previously cleared submission (K231694). | |
| Clinical Test Summary | No clinical studies were performed. |
| Conclusions: Non-Clinical | |
| and Clinical | Astura Medical considers MASADA Modular Spinal Fixation System to be |
| equivalent to the predicate devices listed above. This conclusion is based |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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upon the devices' similarities in principles of operation, technology, materials and indications for use.
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