(67 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a spinal fixation system intended to provide immobilization and support as an adjunct to fusion, rather than directly treating a disease or condition.
No
The device is a spinal fixation system intended to provide immobilization and aid fusion, not to diagnose medical conditions.
No
The device description explicitly states it is composed of physical components like screws, hooks, rods, and crosslinks, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The OLYMPIC Posterior Spinal Fixation System is a system of implants (screws, hooks, rods, etc.) designed to be surgically implanted into the spine to provide structural support and aid in fusion.
- Intended Use: The intended use clearly states that the system is for "immobilization of spinal segments" and is used "as an adjunct to fusion." This is a therapeutic and structural function, not a diagnostic test performed on a sample outside the body.
The information provided describes a surgical implant system, not a diagnostic test.
N/A
Intended Use / Indications for Use
The OLYMPIC Posterior Spinal Fixation System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine (T1-S2/Ilium): degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). When used as an adjunct to fusion, the OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft/allograft.
In addition, the OLYMPIC Posterior Spinal Fixation System is intended for treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after the attainment of a solid fusion. Levels of pedicle and non-pedicle fixation for these patients are L3-sacrum/ilium.
When used for posterior non-cervical pedicle and non-pediatric patients, the OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft. Pediatric pediatric pedicle and non-pedicle fixation is limited to a posterior approach.
Product codes
NKB, KWP
Device Description
The OLYMPIC PSFS is a top loading thoracolumbar, sacral, and iliac fixation system implanted from the posterior approach and designed to provide fixation during the fusion process. The system is composed of preassembled uniplanar screws, hooks, rods, crosslinks, and rod connectors. The system is supported by a comprehensive set of instruments to install the implants within the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine (T1-S2/Ilium), L5-S1 vertebra, lumbosacral spine and/or ilium, L3-sacrum/ilium.
Indicated Patient Age Range
skeletally mature patients, pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Test Summary: The system was analyzed through Dynamic Compression Bending – ASTM F1717. The results of these evaluations indicate that the OLYMPIC PSFS is equivalent to predicate devices.
Clinical Test Summary: No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K153446, K143633, K124058, K113395, K142381, K113666, K071373, K060748, K111136, K131802, K111358, K100952, K000536, K955348, K940631, K950099, K920116, K090390, K162494, K162379
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Image /page/0/Picture/0 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Astura Medical, LLC Mr. Parker Kelch Quality Manager 3168 Lionshead Ave, Suite 100 Carlsbad, California 92010
Re: K181139
Trade/Device Name: OLYMPIC Posterior Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw Systems Regulatory Class: Class II Product Code: NKB, KWP Dated: April 27, 2018 Received: April 30, 2018
Dear Mr. 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 (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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'neill -S
for MNM
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181139
Device Name OLYMPIC Posterior Spinal Fixation System
Indications for Use (Describe)
The OLYMPIC Posterior Spinal Fixation System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine (T1-S2/Ilium): degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). When used as an adjunct to fusion, the OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft/allograft.
In addition, the OLYMPIC Posterior Spinal Fixation System is intended for treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after the attainment of a solid fusion. Levels of pedicle and non-pedicle fixation for these patients are L3-sacrum/ilium.
When used for posterior non-cervical pedicle and non-pediatric patients, the OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft. Pediatric pediatric pedicle and non-pedicle fixation is limited to a posterior approach.
| 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) | |
| AAUHILILE AIL I ARREBIER BLAN IN LINEARR |
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510(k) Summary: OLYMPIC Posterior Spinal Fixation System
| Date Prepared | April 27, 2018 |
|---|---|
| Submitted By | Astura Medical |
| 3186 Lionshead Ave, Suite 100 | |
| Carlsbad, CA 92010 | |
| Phone: 760-814-8047 | |
| Contact | Parker Kelch |
| 3186 Lionshead Ave, Suite 100 | |
| Carlsbad, CA 92010 | |
| Phone: 760-814-8047 x413 | |
| Email: quality@asturamedical.com | |
| Trade Name | OLYMPIC Posterior Spinal Fixation System |
| Common Name | Posterior spinal fixation system |
| Classification Name | Thoracolumbosacral pedicle screw system |
| Spinal interlaminal fixation orthosis | |
| Class | II |
| Product Code | NKB |
| KWP | |
| CFR Section | 21 CFR section 888.3070 |
| 21 CFR section 888.3050 | |
| Device Panel | Orthopedic |
| Primary Predicate Device | OLYMPIC PSFS (K153446) |
| Secondary Predicate Device(s) | Revere®/CREO™ Stabilization System - Globus Medical (K143633 / K124058 / K113395) |
| Xia Spinal System - Stryker (K142381 /K113666 / K071373 / K060748) | |
| Expedium/Viper - DePuy Spine (K111136 / K131802) | |
| Universal Spinal System / Matrix - Synthes (K111358 / K100952) Moss | |
| Miami SS - DePuy Spine (K000536, K955348) | |
| Synergy VLS - open - Cross Medical (K940631 / K950099) | |
| PWB (now Synergy) - Cross Medical (K920116) | |
| CD HORIZON LEGACY – Medtronic (K090390 / K162494 / K162379) | |
| Device Description | The OLYMPIC PSFS is a top loading thoracolumbar, sacral, and iliac |
| fixation system implanted from the posterior approach and designed to | |
| provide fixation during the fusion process. The system is composed of | |
| preassembled uniplanar screws, hooks, rods, crosslinks, and rod | |
| connectors. The system is supported by a comprehensive set of | |
| instruments to install the implants within the system. | |
| Materials | Ti-6Al-4V ELI (ASTM F136) |
| CP Titanium Grade 4 (ASTM F67) | |
| Nitinol #1 (ASTM F2063) | |
| SS 17-4 (ASTM A564) | |
| SS 420 (ASTM A240) | |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The OLYMPIC PSFS is substantially equivalent to the predicate devices in |
| terms of intended use, design, materials used, mechanical safety and | |
| performances. | |
| Indications for Use | The OLYMPIC Posterior Spinal Fixation System is 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 thoracic, lumbar, and sacral spine | |
| (T1-S2/Ilium): degenerative spondylolisthesis with objective evidence of | |
| neurological impairment, fracture, dislocation, deformities or curvatures | |
| (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, and failed previous | |
| fusion (pseudarthrosis). When used as an adjunct to fusion, the | |
| OLYMPIC Posterior Spinal Fixation System is intended to be used with | |
| autograft/allograft. | |
| In addition, the OLYMPIC Posterior Spinal Fixation System is intended | |
| for treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 | |
| vertebra in skeletally mature patients receiving fusion by autogenous bone | |
| graft, having implants attached to the lumbosacral spine and/or ilium with | |
| removal of the implants after the attainment of a solid fusion. Levels of | |
| pedicle and non-pedicle fixation for these patients are L3-sacrum/ilium. | |
| When used for posterior non-cervical pedicle and non-pedicle fixation in | |
| pediatric patients, the OLYMPIC Posterior Spinal Fixation System is | |
| intended to be used with autograft and/or allograft. Pediatric pedicle and | |
| non-pedicle fixation is limited to a posterior approach. | |
| Non-clinical Test | |
| Summary | The system was analyzed through Dynamic Compression Bending – ASTM |
| F1717. | |
| The results of these evaluations indicate that the OLYMPIC PSFS is | |
| equivalent to predicate devices. | |
| Clinical Test | |
| Summary | No clinical studies were performed. |
| Conclusions: Non- | |
| Clinical and Clinical | Astura Medical considers OLYMPIC PSFS to be 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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