(220 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system comprised of screws, rods, crosslinks, and connectors. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical properties and biocompatibility.
Yes
Explanation: The device is intended to provide immobilization of the spine as an adjunct to fusion for treating various acute and chronic instabilities or deformities, which are specific medical conditions, and it is a physical component attached to the body for a therapeutic purpose (stabilization and fusion).
No
The device description indicates that the Orthopeasia Spinal Fixation System is a surgical implant designed to provide immobilization and stabilization of the spine as an adjunct to fusion. Its components are used to build a spinal implant construct, and it is attached to the vertebral body by screw fixation. This functionality is therapeutic, not diagnostic.
No
The device description explicitly states it is a "multiple component system comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy" including screws, rods, crosslinks, and connectors. This indicates it is a hardware-based medical device.
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 the Orthopeasia Spinal Fixation System is a system of implants (screws, rods, etc.) intended to be surgically implanted into the spine to provide immobilization and stabilization. It is a physical device used in the body, not a test performed on a sample from the body.
- Lack of IVD-related terms: The text does not mention any laboratory testing, analysis of biological samples, or diagnostic purposes in the context of in vitro procedures.
Therefore, the Orthopeasia Spinal Fixation System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Orthopeasia Spinal Fixation System is intended to provide immobilization of the posterior non-cervical spine (T1-S2/Illium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities:
-
Degenerative disc disease (defied as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies):
-
Degenerative spondylolisthesis with objective evidence of neurologic impairment;
-
Trauma (i.e., fracture or dislocation);
-
Deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis);
-
Tumor;
-
Stenosis;
-
Failed previous fusion (pseudarthrosis)
The Orthopeasia Spinal Fixation System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after the attainment of a solid fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The Orthopeasia Spinal Fixation System is a temporary, multiple component system comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screw fixation to the non-cervical spine. The system consists of a variety of shapes and sizes of screws, rods, crosslinks and connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine.
The Orthopeasia Spinal Fixation System is this submission comprises of the following components,
A. Pedicle screws (Mono-axial and Poly-axial), standard, cannulated, with:
- a. Monoaxial screw diameters from 5.5mm to 8.5mm
- b. Polyaxial screw diameters from 5.5mm to 8.5mm
- c. Monoaxial length range from 20mm to 55mm
- d. Polyaxial length range from 20mm to 100mm
- e. Made up of titanium alloy (ASTM F136).
- B. Straight rods of diameter of 5.0 mm made up of cobalt chrome alloy (ASTM F1537)
- C. Crosslinks and connectors made up of titanium alloy (ASTM F136).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior non-cervical spine (T1-S2/Illium), L5-S1 vertebral joint, lumbar and sacral spine (L3 to sacrum)
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)
- Biocompatibility Evaluation: per 10993-1
- Sterilization Validation: refer to Section 14 Sterilization and Shelf Life
- Static and Dynamic Compression Bending:
- Study Type: Testing to ASTM F1717 to determine the mechanical properties of spinal implant assemblies in a vertebrectomy model under static and dynamic axial compression.
- Key Results: The results were above the range reached by implants of the additional predicate (lumbar polyaxial device).
- Static axial and torsion grip test:
- Study Type: Testing to ASTM F1798
- Key Results: The results were within the range reached by predicate devices. Therefore, the results passed.
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.
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.
0
August 30, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image 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.
Orthopeasia Co., Ltd % Joseph Azary Regulatory Consultant Aztech Regulatory & Quality LLC 543 Long Hill Avenue Shelton, Connecticut 06484
Re: K240180
Trade/Device Name: Orthopeasia Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: August 1, 2024 Received: August 1, 2024
Dear Joseph Azary:
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).
1
approvals in the device master record (21 CFR 820.181).
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
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 medical devices and radiation-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,
Image /page/1/Picture/6 description: The image shows a digital signature for Eileen Cadel. The signature includes the name "Eileen Cadel - S" in a large font on the left side of the image. On the right side, it states that the signature is digitally signed by Eileen Cadel, with a date and time stamp of 2024.08.30 14:41:21 -04'00'.
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
2
Indications for Use
Submission Number (if known)
Device Name
Orthopeasia Spinal Fixation System
Indications for Use (Describe)
The Orthopeasia Spinal Fixation System is intended to provide immobilization of the posterior non-cervical spine (T1-S2/Illium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities:
-
Degenerative disc disease (defied as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies):
-
Degenerative spondylolisthesis with objective evidence of neurologic impairment;
-
Trauma (i.e., fracture or dislocation);
-
Deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis);
-
Tumor;
-
Stenosis;
-
Failed previous fusion (pseudarthrosis)
The Orthopeasia Spinal Fixation System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after the attainment of a solid fusion.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
r-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary Traditional 510(k) Orthopeasia Spinal Fixation System
SUBMITTER/510(K) HOLDER 1.
Orthopeasia Co., Ltd. 33/15 Moo 10, Theparak Road Bangpla, Bangplee, Samutprakarn TH-10540 Thailand
Submission Contact
Joseph Azary Aztech Regulatory & Quality LLC 543 Long Hill Avenue Shelton, CT 06484
Email: jazary@erols.com Alternate Email: jazary@aztechregulatory.com
Telephone: (203) 242-6670
Date Prepared: August 29, 2024
Reason for 510(k): New device / Initial Submission
2. DEVICE NAME
| Proprietary Name: | Orthopeasia Spinal Fixation System |
|---|---|
| Classification Name: | Thoracolumbosacral Pedicle Screw System |
| Common Name: | Thoracolumbosacral Pedicle Screw System |
| Classification Regulation: | 21 CFR 888.3070 |
| Product Code: | NKB |
| Classification: | Class 2 |
| Medical Specialty (Panel): | Orthopedic |
4
| Type of Predicate | Device Name | Manufacturer | 510(k)
Number |
|-------------------------|------------------------------------|-------------------|-----------------------------|
| | | | Product Code |
| Primary | Firebird Spinal
Fixation System | Orthofix, Inc | K130932
NKB, KWP,
OSH |
| Additional
Predicate | LOPSA IS Spinal
Fixation System | Corentec Co., Ltd | K200267
NKB, KWQ |
3. PREDICATE DEVICES
4. DEVICE DESCRIPTION
The Orthopeasia Spinal Fixation System is a temporary, multiple component system comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screw fixation to the non-cervical spine. The system consists of a variety of shapes and sizes of screws, rods, crosslinks and connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine.
The Orthopeasia Spinal Fixation System is this submission comprises of the following components,
A. Pedicle screws (Mono-axial and Poly-axial), standard, cannulated, with:
- a. Monoaxial screw diameters from 5.5mm to 8.5mm
- b. Polyaxial screw diameters from 5.5mm to 8.5mm
- c. Monoaxial length range from 20mm to 55mm
- d. Polyaxial length range from 20mm to 100mm
- e. Made up of titanium alloy (ASTM F136).
- B. Straight rods of diameter of 5.0 mm made up of cobalt chrome alloy (ASTM F1537)
- C. Crosslinks and connectors made up of titanium alloy (ASTM F136).
న. INDICATIONS FOR USE
The Orthopeasia Spinal Fixation System is intended to provide immobilization and stabilization of the posterior non-cervical spine (T1-S2/Illium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities:
5
- 트 Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies);
- . Degenerative spondylolisthesis with objective evidence of neurologic impairment;
- Trauma (i.e., fracture or dislocation);
- ' Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis):
- Tumor;
- 트 Stenosis;
- I Failed previous fusion (pseudoarthrosis)
The Orthopeasia Spinal Fixation System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5 - S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after the attainment of a solid fusion.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The subject device has similar indications, materials, components, sterility status, single use, dimensions and instrumentation as compared to predicate devices. The differences include some minor differences in the wording of the indications for use, the additional predicate can be used for pediatric, and the subject devices are offered in longer lengths. Based on the testing to consensus standards (including worst case) and comparison to predicate devices, we conclude the differences do not impact safety or efficacy of the devices.
The minor differences include that primary predicate (Firebird) has a subset that can be used for pediatric patients, whereas the Firebird and Orthopeasia systems are for skeletally mature patients.
The technological design features of the subject Orthopeasia Spinal Fixation System is substantially equivalent to the predicate devices. The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function, and technology and it was demonstrated that they are substantially equivalent.
6
7. PERFORMANCE TESTING
The Orthopeasia devices were subjected to a variety of testing including:
- -Biocompatibility Evaluation per 10993-1 (refer to Section ાં ર ISO Biocompatibility)
- Sterilization Validation (refer to Section 14 Sterilization and Shelf Life) -
In addition to the above referenced testing, the device was subjected to the testing outlined below.
| Test Name | Test Description and
Objective | Test Results / Summary |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Static and
Dynamic
Compression
Bending | Testing to ASTM F1717 to
determine the mechanical
properties of spinal implant
assemblies in a vertebrectomy
model under static and
dynamic axial compression. | The results were above the range reached by implants of
the additional predicate (lumbar polyaxial device). |
| Static axial and
torsion grip test | Testing to ASTM F1798 | The results were within the range reached by predicate
devices. Therefore, the results passed. |
8. CONCLUSION
The information presented supports substantial equivalence of the Orthopeasia Spinal Fixation System to the predicate device based on similarities in intended use, design, principles of operation and performance specifications.
The company concluded that based on testing, compliance to consensus standards, the indications for use, technological characteristics, and comparison to predicate devices, Orthopeasia Co., Ltd. found that the subject device is substantially equivalent to the predicate devices.