(63 days)
No
The summary describes a mechanical pedicle screw system and does not mention any software, algorithms, or AI/ML capabilities.
No
The device provides immobilization and stabilization of spinal segments as an adjunct to fusion, which are mechanical functions, not therapeutic. Its purpose is to support healing, not to directly treat disease or pain using therapeutic modalities.
No
The device is a Pedicle Screw System intended for immobilization and stabilization of spinal segments as an adjunct to fusion, which is a treatment rather than a diagnostic process.
No
The device description explicitly lists physical components made of Titanium Alloy (Ti6Al4V), such as rods, screws, and connectors, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes the Pagoda™ Pedicle Screw System as a system of implants (screws, rods, connectors) intended for surgical implantation to stabilize the spine. It is a physical device used within the body, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components, processes, or intended uses related to analyzing biological specimens.
Therefore, based on the provided information, the Pagoda™ Pedicle Screw System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pagoda™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, noncervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1 – S1/Ileum) for the following indications:
- Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Degenerative Spondylolisthesis with objective evidence of neurologic impairment
- Trauma (fracture or dislocation)
- Spinal tumor
- Failed previous fusion (pseudarthrosis)
- Spinal stenosis
- Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis
Product codes
NKB, MNI, MNH
Device Description
The Pagoda™ Pedicle Screw System consists of rods, polyaxial screws, reduction screws, monoaxial screws, set screws, transverse connectors, and offset connectors which can be variously assembled to provide immobilization of the thoracolumbar and lumbosacral spine. All components are made from Titanium Alloy (Ti6Al4V).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar and lumbosacral spine, thoracic, lumbar, and sacral/iliac spine (T1 – S1/Ileum)
Indicated Patient Age Range
skeletally mature 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical tests were conducted:
- . Static and dynamic compression testing per ASTM F1717
- . Static torsion testing per ASTM F1717
Mechanical test results demonstrate that the proposed Pagoda™ Pedicle Screw System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pangea (K052123), Tiger (K113058), Synergy Helical Flange Plug (K041449), MOSS Miami (K964024)
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.
0
510(k) Summary
| NAME OF SPONSOR: | Ortho Development® Corporation
12187 South Business Park Drive
Draper, Utah 84020 | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k) CONTACT: | Tom Haueter
Regulatory Affairs Manager
Telephone: (801) 553-9991
Facsimile: (801) 553-9993
Email: thaueter@orthodevelopment.com | |
| DATE PREPARED: | 29 May, 2013 | |
| PROPRIETARY NAME: | Pagoda™ Pedicle Screw System | |
| COMMON NAME: | Pedicle Screw Spinal System | |
| CLASSIFICATION: | 21 CFR Sec. 888.3070 Pedicle screw fixation | |
| DEVICE CLASS: | Class III | |
| DEVICE PRODUCT CODE: | NKB
MNI
MNH | |
| PREDICATE DEVICES: | Pangea (K052123)
Synthes Orthopedics | |
| | Tiger (K113058)
Corelink, LLC | |
| | Synergy Helical Flange Plug (K041449)
Interpore Cross, LLC | |
| | MOSS Miami (K964024) | |
Depuy Motech
:
Section 5, 510(k) Summary
1
Description
The Pagoda™ Pedicle Screw System consists of rods, polyaxial screws, reduction screws, monoaxial screws, set screws, transverse connectors, and offset connectors which can be variously assembled to provide immobilization of the thoracolumbar and lumbosacral spine. All components are made from Titanium Alloy (Ti6Al4V).
Indications
The Pagoda™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, noncervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1 – S1/Ileum) for the following indications:
-
- Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
-
- Degenerative Spondylolisthesis with objective evidence of neurologic impairment
-
- Trauma (fracture or dislocation)
-
- Spinal tumor
-
- Failed previous fusion (pseudarthrosis)
-
- Spinal stenosis
-
- Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis
Basis for Substantial Equivalence
Pagoda™ Pedicle Screw System was evaluated in accordance with FDA Documents, Guidance for Industry and FDA Staff; Spinol System 510(k)s, May 3, 2004, and has been found to meet criteria defined in the guidance documents.
The following non-clinical tests were conducted:
- . Static and dynamic compression testing per ASTM F1717
- . Static torsion testing per ASTM F1717
Conclusions
Based on similarities in intended use, design, materials, manufacturing methods, and packaging, Pagoda™ Pedicle Screw System has demonstrated that it is substantially equivalent to the previously cleared predicate devices. Mechanical test results demonstrate that the proposed Pagoda™ Pedicle Screw System is substantially equivalent to the predicate devices.
2
Image /page/2/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 an abstract symbol resembling an eagle or bird-like figure, composed of three curved lines that suggest wings or flowing fabric.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2013
Mr. Tom Haueter Regulatory Affairs Manager Ortho Development® Corporation 12187 South Business Park Drive Draper, Utah 84020
Re: K131785
Trade/Device Name: Ortho Development® Pagoda™ Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: June 11, 2013 Received: June 18, 2013
Dear Mr. Haueter:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Tom Haueter
forth in the quality systems (OS) 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 Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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
4
Indications for Use
510(k) Number (if known):
Device Name: Ortho Development® Pagoda™ Pedicle Screw System
Indications for Use:
The Pagoda™ Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, noncervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T) -S1/lleum) for the following indications:
-
- Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
-
- Degenerative Spondylolisthesis with objective evidence of neurologic impairment
-
- Trauma (fracture or dislocation)
-
- Spinal tumor
-
- Failed previous fusion (pseudarthrosis)
-
- Spinal stenosis
-
- Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131785