(133 days)
Not Found
No
The summary describes a mechanical spinal fixation system and its components. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities that would suggest the use of AI/ML. The performance studies are non-clinical mechanical tests.
Yes
The device is a posterior spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion, treating various acute and chronic instabilities, deformities, and conditions of the spine. Its purpose is to facilitate healing and correct spinal issues, which qualifies it as a therapeutic device.
No
This device is a spinal fixation system, used as an adjunct to fusion for treating various spinal instabilities and deformities. It is an implantable device designed for structural support and immobilization, not for diagnosis.
No
The device description explicitly states it is a "thoracolumbar, sacral, and iliac fixation system implanted from the posterior approach" and is "composed of preassembled polyaxial screws, monoaxial screws, rods, crosslinks, and rod connectors." This describes physical hardware implants, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used to provide mechanical support and stabilization to the spine during fusion. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details physical components like screws, rods, and connectors, which are typical of surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
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 following acute and chronic instabilities of thoracic, lumbar, and sacral spine (T1-S2/ilium): degenerative spondylolisthesis with objective evidence of neuroment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). When used as an adjunct to fusion, the OLYMPIC Posterior System is intended to be used with autograft/allograft.
In addition, the OLYMPIC Posterior System is intended for treatment of severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or illum with removal of the implants after the attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used for posterior non-cervical pediatic patients, the OLYMPIC Posterior Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idionathic scoliosis. The OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes (comma separated list FDA assigned to the subject device)
OSH, MNI, MNH
Device Description
The OLYMPIC Posterior Spinal Fixation System 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 polyaxial screws, monoaxial screws, 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 (adolescent idiopathic 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: Finite Element Analysis to determine worst case for testing Static Compression Bending - ASTM F1717 Dynamic Compression Bending - ASTM F1717 Static Torsion - ASTM F1717 Axial grip - ASTM F1798 Torsional grip - ASTM F1798 Corrosion testing - ASTM F2129. The results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is 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.
K143633, K142381, K113666, K071373, K060748, K111136, K131802, K111358, K100952, K000536, K955348, K940631, K950099, K920116, K062912, K050451, K093434
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 8, 2016
Astura Medical, LLC % Mr. J.D. Webb Authorized Contact Person The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K153446
Trade/Device Name: OLYMPIC Posterior Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: OSH, MNI, MNH Dated: March 9, 2016 Received: March 10, 2016
Dear Mr. Webb:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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 following acute and chronic instabilities of thoracic, lumbar, and sacral spine (T1-S2/ilium): degenerative spondylolisthesis with objective evidence of neuroment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). When used as an adjunct to fusion, the OLYMPIC Posterior System is intended to be used with autograft/allograft.
In addition, the OLYMPIC Posterior System is intended for treatment of severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or illum with removal of the implants after the attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used for posterior non-cervical pediatic patients, the OLYMPIC Posterior Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idionathic scoliosis. The OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft. Pediatric pedicle screw 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary: OLYMPIC Posterior Spinal Fixation System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
| Date Prepared | April 5, 2016 |
|---|---|
| Submitted By | Astura Medical, LLC |
| 5670 El Camino Real, Suite B | |
| Carlsbad, CA 92008 | |
| 760-814-8047 Tele | |
| Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| 512-692-3699 Fax | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | OLYMPIC Posterior Spinal Fixation System |
| Common Name | pedicle screw system |
| Classification Name | Pedicle screw spinal system |
| Class | II |
| Product Code | OSH - Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| MNI - Orthosis, Spinal Pedicle Fixation | |
| MNH - Orthosis, Spondylolisthesis Spinal Fixation | |
| CFR Section | 21 CFR section 888.3070 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | Revere®/CREO™ Stabilization System - Globus Medical (K143633) |
| Secondary Predicate | |
| Devices | 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), Ti-6AI-4V (K955348) | |
| Synergy VLS - open - Cross Medical (K940631 / K950099) | |
| PWB (now Synergy) - Cross Medical (K920116) | |
| Polyaxial LP - Scient'x (K062912) | |
| Vectra System - Synthes (K050451) | |
| VERTEX Reconstruction System - Medtronic (K093434) | |
| Device Description | The OLYMPIC Posterior Spinal Fixation System 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 polyaxial screws, monoaxial screws, 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 F37) | |
| CoCr alloy (ASTM F1537) | |
| Elgiloy CoCrNi alloy (ASTM F1058) | |
| Nitinol #1 (ASTM F2063) | |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The OLYMPIC Posterior Spinal Fixation System 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 screw fixation for
these patients are L3-sacrum/ilium.
When used for posterior non-cervical pedicle screw fixation in pediatric patients,
the OLYMPIC Posterior Spinal Fixation System implants are indicated as an
adjunct to fusion to treat adolescent idiopathic scoliosis. The OLYMPIC Posterior
Spinal Fixation System is intended to be used with autograft and/or allograft.
Pediatric pedicle screw fixation is limited to a posterior approach. |
| Non-clinical Test
Summary | The following analyses were conducted:
Finite Element Analysis to determine worst case for testing Static Compression Bending - ASTM F1717 Dynamic Compression Bending - ASTM F1717 Static Torsion - ASTM F1717 Axial grip - ASTM F1798 Torsional grip - ASTM F1798 Corrosion testing - ASTM F2129 The results of these evaluations indicate that the OLYMPIC Posterior Spinal
Fixation System is equivalent to the predicate devices. |
| Clinical Test
Summary | No clinical studies were performed |
| Conclusions: Non-
clinical and Clinical | Astura Medical considers OLYMPIC Posterior Spinal Fixation System 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 |
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