(285 days)
Not Found
No
The 510(k) summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is an implantable system intended to provide immobilization and stabilization of spine segments to treat various spinal conditions, functioning as a therapeutic intervention.
No
The device description indicates it is an implantable system for immobilization and stabilization of spine segments, not for diagnosis.
No
The device description clearly states it is an "implantable system" consisting of physical components like pedicle screws, modular tulips, spinal rods, and set screws, all made of implantable-grade titanium. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Pisces Spinal System Function: The Pisces Spinal System is an implantable surgical device. Its purpose is to provide structural support and immobilization to the spine within the patient's body as an adjunct to fusion. It does not perform any diagnostic tests on bodily samples.
The description clearly outlines a system of screws, rods, and other components designed for surgical implantation to stabilize the spine. This falls under the category of surgical implants, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Pisces Spinal 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, non-cervical pedicle fixation of the thoracic, lumbar, sacrum and iliac spine (T1-Sacrum/Ilium) 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
The Pisces Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft or allograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, sacrum and iliac spine (T1-Sacrum/Ilium) 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
Device Description
The Pisces Spinal System is an implantable system intended to provide immobilization and stabilization of spine segments. The subject device is a modular pedicle screw assembly that consists of pedicle screws with solid and cannulated options, modular tulips in standard, reduction, and extended tab configurations, spinal rods, and set screws. All components are made of implantable-grade titanium.
The modular tulip is an assembly which consists of a tulip body, a saddle, and a locking ring. The top of the tulip body receives a locking set screw which secures the tulip body assembly to an ø5.5mm or ø6.0mm rod and pedicle screw when tightened.
The pedicle screw has a spherical head which the tulip assembly snaps onto either before or after surgical insertion. The 5.5mm or 6.0mm rod is inserted into the tulip assembly. After assembly of multiple pedicle screws, a set screw is inserted into the tulip and locked to a predetermined locking torque, immobilizing the construct. For the 20mm reduction and 90mm extended tab tulips, the guide tabs are removed from the construct following final lock. 20mm reduction tabs can be used to provide length for rod reduction while 90mm tab tulips facilitate minimally invasive surgeries (MIS). All implants are provided sterile for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical pedicle fixation of the thoracic, lumbar, sacrum and iliac spine (T1-Sacrum/Ilium)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Sterilization: Pisces Spinal System is gamma radiation sterilized and was validated to a sterility assurance level of 10-6 in accordance with ISO 11137-1: 2006, Am1: 2013, and ISO 11137-2:2013. Validation results indicate that the Pisces Spinal System complies with the standards.
Shelf Life: The packaging for Pisces Spinal System was validated in accordance with ISO 11607-1: 2006 and ISO 11607-2: 2006. Validation results indicate that the packaging for the Pisces Spinal System complies with the standards.
Biocompatibility: The Pisces Spinal System contact materials were verified in accordance with ISO 10993-1: 2009 and ANSI/AAMI ST72:2011. Validation results indicated that the patient contact materials comply with the standard.
Mechanical Testing:
- Static Compression Testing per ASTM F1717
- Dynamic Compression Testing per ASTM F1717
- Static Torsion Testing per ASTM F1717
- Flexion-Extension Testing per ASTM F1798
- Static Anterior-Posterior Loading Testing per ASTM F1798
Bacterial Endotoxin Testing: Bacterial endotoxin testing is performed per ANSI/AAMI ST72:2011 using the limulus amebocyte lysate (LAL) pyrogen testing methodology at a test limit of 20 EU/device. Testing met the predetermined acceptance criteria. Routine monitoring of endotoxins in the manufacturing process is performed quarterly.
Clinical Testing: None provided for basis of substantial equivalence.
Key results: The results of these activities demonstrate that the Pisces Spinal System is as safe, as effective, and performs as well as or better than legally marketed predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pagoda Pedicle Screw System (K131785), Ibis Pedicle Screw System (K142146)
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
Image /page/0/Picture/0 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 is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
July 14, 2021
Ortho Development Corporation Darlene Hull Director of Regulatory & Clinical Affairs 12187 South Business Park Drive Draper, Utah 84020
Re: K203023
Trade/Device Name: Pisces Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: June 4, 2021 Received: June 7, 2021
Dear Darlene Hull:
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. 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 located 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.
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
1
801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 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 (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,
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203023
Device Name Pisces Spinal System
Indications for Use (Describe)
The Pisces Spinal 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, non-cervical pedicle fixation of the thoracic, lumbar, sacrum and iliac spine (T1-Sacrum/Ilium) 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
| 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)
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Image /page/3/Picture/1 description: The image shows the logo for Ortho Development. The logo is purple and includes the word "ORTHO" in large letters, with the word "DEVELOPMENT" underneath in smaller letters. The image also includes the text "K203023" and "Page 1 of 5" in the upper right corner.
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
| Name of the Sponsor | Ortho Development® Corporation |
|---|---|
| 12187 South Business Park Drive | |
| Draper, Utah 84020 | |
| 510(k) Primary Contact | Darlene Hull |
| Director of Regulatory & Clinical Affairs | |
| Telephone: (801) 619-3499 | |
| Email: dhull@orthodevelopment.com | |
| Date Prepared: | September 30, 2020 |
| Submission Type: | Traditional 510(k) |
| Proprietary Name: | Pisces Spinal System |
| Common Name: | Thoracolumbosacral Pedicle Screw System |
| Classification: | 21 CFR 888.3070 |
| Device Class: | Class II |
| Product Code: | NKB |
| Primary Predicate: | Pagoda Pedicle Screw System (K131785) |
| Secondary Predicate: | Ibis Pedicle Screw System (K142146) |
4
Image /page/4/Picture/1 description: The image shows the logo for Ortho Development. The logo consists of a purple circle with three curved lines emanating from the left side, followed by the word "ORTHO" in purple block letters. Below the word "ORTHO" is the word "DEVELOPMENT" in a smaller, lighter font. In the upper right corner of the image, the text "K203023 Page 2 of 5" is visible.
Device Description:
The Pisces Spinal System is an implantable system intended to provide immobilization and stabilization of spine segments. The subject device is a modular pedicle screw assembly that consists of pedicle screws with solid and cannulated options, modular tulips in standard, reduction, and extended tab configurations, spinal rods, and set screws. All components are made of implantable-grade titanium.
The modular tulip is an assembly which consists of a tulip body, a saddle, and a locking ring. The top of the tulip body receives a locking set screw which secures the tulip body assembly to an ø5.5mm or ø6.0mm rod and pedicle screw when tightened.
The pedicle screw has a spherical head which the tulip assembly snaps onto either before or after surgical insertion. The 5.5mm or 6.0mm rod is inserted into the tulip assembly. After assembly of multiple pedicle screws, a set screw is inserted into the tulip and locked to a predetermined locking torque, immobilizing the construct. For the 20mm reduction and 90mm extended tab tulips, the guide tabs are removed from the construct following final lock. 20mm reduction tabs can be used to provide length for rod reduction while 90mm tab tulips facilitate minimally invasive surgeries (MIS). All implants are provided sterile for single use only.
Indication for Use:
The Pisces Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft or allograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, sacrum and iliac spine (T1-Sacrum/Ilium) 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)
5
Image /page/5/Picture/1 description: The image shows a logo for a company called "Ortho Development". The logo is purple and gray. The text "K203023 Page 3 of 5" is in the upper right corner of the image.
6. Spinal stenosis
-
- Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis
Comparison of Technological Characteristics:
The Pisces Spinal System is technologically similar to the already cleared predicate device Pagoda Pedicle Screw System and Ibis Pedicle Screw System in terms of Indication for use/intended use, material, technological characteristics, mechanical performance, and principle of operation.
Performance Data
Sterilization
Pisces Spinal System is gamma radiation sterilized and was validated to a sterility assurance level of 10-6 in accordance with the following standards:
- . ISO 11137-1: 2006, Am1: 2013, Sterilization of health care products -Requirements for validation and routine control - Radiation sterilization; and
- ISO 11137-2:2013, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
Validation results indicate that the Pisces Spinal System complies with the standards.
Shelf Life
The packaging for Pisces Spinal System was validated in accordance with the following standards:
- . ISO 11607-1: 2006 Packaging for terminally sterilized medical devices - Part 1: requirements for materials, sterile barrier systems and packaging systems; and
- . ISO 11607-2: 2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
6
Image /page/6/Picture/1 description: The image shows the logo for "Ortho Development". The logo is purple and features a stylized image of three curved lines on the left. To the right of the image is the word "ORTHO" in large, bold letters. Below the word "ORTHO" is the word "DEVELOPMENT" in smaller letters. Above the logo is the text "K203023 Page 4 of 5".
Validation results indicate that the packaging for the Pisces Spinal System complies with the standards.
Biocompatibility
The Pisces Spinal System contact materials were verified in accordance with the following standards:
- ISO 10993-1: 2009, Biological evaluation of medical devices Part 1: Evaluation ● and testing within a risk management process.
- . ANSI/AAMI ST72:2011
Validation results indicated that the patient contact materials comply with the standard.
Mechanical Testing
The following mechanical testing were performed on the Pisces Spinal System
- Static Compression Testing per ASTM F1717 ●
- Dynamic Compression Testing per ASTM F1717 ●
- Static Torsion Testing per ASTM F1717
- . Flexion-Extension Testing per ASTM F1798
- . Static Anterior-Posterior Loading Testing per ASTM F1798
Bacterial Endotoxin Testing
Bacterial endotoxin testing is performed per ANSI/AAMI ST72:2011 using the limulus amebocyte lysate (LAL) pyrogen testing methodology at a test limit of 20 EU/device. Testing met the predetermined acceptance criteria. Routine monitoring of endotoxins in the manufacturing process is performed quarterly.
Clinical Testing
None provided for basis of substantial equivalence
Substantial Equivalence Conclusion:
Verification and Validation activities were conducted to establish the performance of the Pisces Spinal System. The results of these activities demonstrate that the Pisces Spinal System is as safe, as effective, and performs as well as or better than legally marketed predicates.
7
12187 So. Business Park Drive Draper, Utah 8402 801-553-9991/ fax 553-999 Orthodevelopment.com
Image /page/7/Picture/1 description: The image shows the logo for Ortho Development. The logo is purple and includes the company name. The text "K203023 Page 5 of 5" is located in the upper right corner of the image.
Based on similarities in indications for use/intended use, material, technological characteristics, mechanical performance, and principle of operation, the Pisces Spinal System is considered substantially equivalent to the previously cleared predicate devices.