(133 days)
Medtronic CD HORIZON® Spinal System (K090390)
Not Found
No
The summary describes a traditional spinal fusion system consisting of implants and instruments, with no mention of AI or ML capabilities.
No.
A therapeutic device is one that treats a disease or condition. This device, the GoPLF! Posterior Lateral Fusion System, is an implantable system of pedicle screws and rods designed to provide immobilization and stabilization of spinal segments as an adjunct to spinal fusion. While it addresses issues like degenerative disc disease or spinal stenosis, its primary function is to stabilize the spine, supporting surgical fusion rather than actively treating or delivering therapy.
No
Explanation: This device is a surgical fixation system consisting of implants (pedicle screws and rods) and instruments used to stabilize spinal segments as an adjunct to fusion. It is not used for diagnosing medical conditions but for treatment.
No
The device description explicitly states that the system consists of "implants and instruments," which are physical hardware components.
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.
- Device Description: The GetSet Surgical GoPLF! Posterior Lateral Fusion System is described as a system of implants (pedicle screws, rods) and instruments used for surgical fixation of the spine. It is physically implanted into the body.
- Intended Use: The intended use is for posterior, non-cervical fixation as an adjunct to fusion in the treatment of various spinal conditions. This is a surgical procedure, not a diagnostic test performed on a sample.
The information provided clearly indicates a surgical implant system, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The GetSet Surgical GoPLF! Posterior Lateral Fusion System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.
The GoPLF! Posterior Lateral Fusion System is for prescription use only and is to be used in an open, posterior approach, and can be used with autograft and/or allograft.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The GetSet Surgical GoPLF! Posterior Lateral Fusion System is offered sterile and consists of implants and instruments.
The GoPLF! Posterior Lateral Fusion System Implants consist of a variety of sizes of pedicle screws, and rods designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients. The pedicle screws are intended to be inserted bilaterally into the pedicles of each vertebral segment, connected with the rod, and intended for spinal fusion at the selected level. The system conforms to patient anatomy for placement in the thoracolumbar human spine and for iliosacral fixation.
The GoPLF! Posterior Lateral Fusion System is offered with GetSet GoPLF! general and system-specific instruments as accessories. The method of use of the instruments is provided in the Surgical Technique Guide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical fixation; thoracolumbar human spine; iliosacral fixation
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)
There are no clinical data generated and held by the manufacturer, i.e., no premarketing or post-market clinical studies or animal studies have been performed. The following information is provided in support of substantial equivalence.
Biocompatibility: The biological evaluation was assessed for potential effects according to ISO 10993-1. The GetSet Surqical GoPLF! Posterior Lateral Fusion devices are manufactured from Ti-6AI-4V ELI conforming to ASTM standard F136. The evaluation was based on product-specific tests and on published literature data. The results show that implants made of Ti-6AI-4V ELI have a high demonstrable biological safety. No concerns arose that would preclude clinical use of GoPLF! Posterior Lateral Fusion System. The instruments are classified as externally communicating medical devices with tissue/bone contact and less than 24 hours contact. All used materials have a medical grade. The requirements of the ISO 10993 standard are fulfilled.
Pyrogenicity / Endotoxin Testing: The bacterial endotoxin test was performed utilizing worst case subject implants to verify that the subject implants meet the acceptance criteria of , Bacterial Endotoxins Test, and EP Ch 2.6.14 Bacterial Endotoxins as recommended in ISO 10993-11:2009 Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity.
Mechanical Testing: To demonstrate equivalence to the predicate device, the CD HORIZON® Spinal System, testing was performed according to ASTM F1717-15, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model". The GoPLF! Pedicle Screw System is geometrically and mechanically equivalent to the predicate device.
Magnetic Resonance Safety Testing: Nonclinical testing has demonstrated that the GetSet Surgical GoPLF! Posterior Lateral Fusion Device range is "MR Conditional" in accordance with the ASTM F2503-20 standard definitions.
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.
Medtronic CD HORIZON® Spinal System (K090390)
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
January 11, 2021
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GetSet Surgical, SA % Carolyn Guthrie Director of Regulatory & Quality Kapstone Medical, LLC 520 Elliot St. Charlotte, North Carolina 28202
Re: K202505
Trade/Device Name: GetSet Surgical GoPLF! Posterior Lateral Fusion System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: January 6, 2021 Received: January 7, 2021
Dear Carolyn Guthrie:
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 mediation-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,
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
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
GetSet Surgical GoPLF! Posterior Lateral Fusion System
Indications for Use (Describe)
The GetSet Surgical GoPLF! Posterior Lateral Fusion System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.
The GoPLF! Posterior Lateral Fusion System is for prescription use only and is to be used in an open, posterior approach, and can be used with autograft and/or allograft.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ 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 is a logo for GetSet Surgical. The word "Get" is in gray, and the word "Set" is in green. The word "Surgical" is in small gray letters below the word "Set". To the left of the word "Get" is a green graphic of three people holding hands in a circle.
Traditional 510(k) Submission GetSet Surgical GoPLF! Posterior Lateral Fusion System
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.
1. Date of Preparation:
November 17, 2020
2. Applicant
GetSet Surgical, SA Route de la Corniche 4 1066 Epalinges Switzerland Contact: Ole Stoklund, CEO Phone: +31 733035535.
3. Official Correspondent
Kapstone Medical LLC 520 Elliot St. Charlotte, NC 28202
4. Contact Person:
Carolyn Guthrie Email: cguthrie@kapstonemedical.com Phone: +1 704-737-2866
5. Device Name
Trade Name: GetSet Surgical GoPLF! Posterior Lateral Fusion System Common Name: Pedicle Screw System Regulation Description: Thoracolumbosacral Pedicle Screw System Requlations Number: 21 CFR 888.3070 Product Code: NKB Classification: Class II Panel: Orthopedic
6. Primary Predicate Device
Medtronic CD HORIZON® Spinal System (K090390)
4
Image /page/4/Picture/1 description: The image shows the logo for GetSet Surgical. The word "Get" is in gray, and the word "Set" is in green. The word "Surgical" is in smaller green font below the word "Set". To the left of the word "Get" is a green graphic of three people holding hands in a circle.
Traditional 510(k) Submission GetSet Surgical GoPLF! Posterior Lateral Fusion System
7. Indications for Use:
The GetSet Surgical GoPLF! Posterior Lateral Fusion System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.
The GoPLF! Posterior Lateral Fusion System is for prescription use only and is to be used in an open, posterior approach and can be used with autograft and/or allograft.
8. Device Description
8.1 Product Names
GetSet Surgical (GetSet) GoPLF! Posterior Lateral Fusion System (Pedicle screws, rods, and instruments)
8.2 Intended Performance
The GetSet Surgical GoPLF! Posterior Lateral Fusion System is offered sterile and consists of implants and instruments.
The GoPLF! Posterior Lateral Fusion System Implants consist of a variety of sizes of pedicle screws, and rods designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients. The pedicle screws are intended to be inserted bilaterally into the pedicles of each vertebral segment, connected with the rod, and intended for spinal fusion at the selected level. The system conforms to patient anatomy for placement in the thoracolumbar human spine and for iliosacral fixation.
The GoPLF! Posterior Lateral Fusion System is offered with GetSet GoPLF! general and system-specific instruments as accessories. The method of use of the instruments is provided in the Surgical Technique Guide.
9. Technological Characteristics
As was established in this submission, the subject device GoPLF! Posterior Lateral Fusion System is substantially equivalent to the predicate device, cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate device through comparison in areas including design, intended use, material composition, function and sterilization method.
5
Image /page/5/Picture/1 description: The image is a logo for GetSet Surgical. The word "Get" is in gray, and the word "Set" is in green. The word "Surgical" is in small gray letters below the word "Set". To the left of the word "Get" is a graphic of three people in green and gray.
10. Performance Data
There are no clinical data generated and held by the manufacturer, i.e., no premarketing or post-market clinical studies or animal studies have been performed. The following information is provided in support of substantial equivalence.
10.1 Biocompatibility
The subject device GoPLF! Posterior Lateral Fusion System is classified as an implant device with tissue/bone contact and permanent contact. Therefore, according to ISO 10993-1 the biological evaluation was assessed for potential effects. The GetSet Surqical GoPLF! Posterior Lateral Fusion devices are manufactured from Ti-6AI-4V ELI conforming to ASTM standard F136. The evaluation was based on product-specific tests and on published literature data. The results show that implants made of Ti-6AI-4V ELI have a high demonstrable biological safety. No concerns arose that would preclude clinical use of GoPLF! Posterior Lateral Fusion System. The instruments are classified as externally communicating medical devices with tissue/bone contact and less than 24 hours contact. All used materials have a medical grade. The requirements of the ISO 10993 standard are fulfilled.
10.2 Pyrogenicity / Endotoxin Testing
The bacterial endotoxin test was performed utilizing worst case subject implants to verify that the subject implants meet the acceptance criteria of ≤ 20 EU/kit. Testing was successfully performed, and it was confirmed that the GoPLF! Posterior Lateral Fusion System meets the acceptance criteria of ≤ 20 EU/kit according to USP. General Chapter , Bacterial Endotoxins Test, and EP Ch 2.6.14 Bacterial Endotoxins as recommended in ISO 10993-11:2009 Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity.
10.3 Mechanical Testing
To demonstrate equivalence to the predicate device, the CD HORIZON® Spinal System, testing was performed according to ASTM F1717-15, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model". The GoPLF! Pedicle Screw System is geometrically and mechanically equivalent to the predicate device.
Magnetic Resonance Safety Testing 10.4
Nonclinical testing has demonstrated that the GetSet Surgical GoPLF! Posterior Lateral Fusion Device range is "MR Conditional" in accordance with the ASTM F2503-20 standard definitions.
6
Image /page/6/Picture/1 description: The image is a logo for GetSet Surgical. The logo features the word "Get" in gray and the word "Set" in green. To the left of the word "Get" is a green graphic of three people holding hands in a circle. Below the word "Set" is the word "Surgical" in small gray letters.
11 Conclusion
The GoPLF! Posterior Lateral Fusion System and the predicate device Medtronic CD HORIZON® Spinal System (K090390) have the same "Indications for Use," are available by prescription only, and are provided sterile. Any technical differences, which were identified, do not result in new questions of safety or effectiveness.
Through assessment of technological characteristics, indications for use and performance data, it can be concluded that GoPLF! Posterior Lateral Fusion System is is substantially equivalent to the CD HORIZON® Spinal System.