(612 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of the pedicle screw system, with no mention of AI or ML.
Yes
The device is a pedicle screw fixation system intended for immobilization and stabilization of spinal segments as an adjunct to fusion for treating various spinal conditions, which clearly falls under the definition of a therapeutic device.
No
This device is a pedicle screw fixation system intended to immobilize and stabilize spinal segments, functioning as an implant for treatment rather than a diagnostic tool.
No
The device description explicitly states it consists of physical components like screws, rods, body, bushing, and ball head, fabricated from Titanium alloy. It is a hardware implant system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "pedicle screw fixation system intended for immobilization and stabilization of spinal segments... as an adjunct to fusion." This describes a surgical implant used in vivo (within the body) to treat structural issues of the spine.
- Device Description: The description details the physical components of the system (screws, rods, etc.) and their material (Titanium alloy). This aligns with a surgical implant, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. The purpose is mechanical support and stabilization.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is a pedicle screw fixation system intended for 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:
Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
Spondylolisthesis
Trauma (e.g., fracture or dislocation)
Deformity or curvature (e.g., scoliosis, kyphosis, and/or lordosis)
Tumor
Spinal stenosis
Pseudarthrosis
Failed previous fusion
Paediatric Use:
When used for posterior non-cervical screw fixation in paediatric patients, the GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, it is intended to treat paediatric patients diagnosed with the following conditions:
Spondylolisthesis
Spondylolysis
Fracture caused by tumor and/or trauma.
Paediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
Product codes
NKB
Device Description
The posterior non-cervical pedicle screw spinal system consists of a body, bushing, and ball head screw. Inner Screw, rods complete the spinal construct. The body portion of the screw rotates about the ball head on the screw, which provides increased motion over a fixed post of the polyaxial screw. An increase in motion facilitates the capture of rods that are not perfectly aligned.
The Screws, Rods are fabricated from Titanium alloy.
These implants are supplied non-sterile; the products have to be sterilized prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature patients, paediatric 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)
Non-clinical testing performed for material standards (ASTMF136) and performance standards (ASTM F1717 for static compression bending, static torsion, dynamic compression bending; ASTM F1798 for axial grip, flexion-extension). Clinical information was not necessary to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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October 10, 2024
Greens Surgicals Pvt. Ltd. Dr. Vinay Kumar Director Plot No. 508-512, Savli Industrial Estate, GIDC Manjusar Vadodara. Gujarat 391 775 India
Re: K230325
Trade/Device Name: GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: September 9, 2024 Received: September 9, 2024
Dear Dr. Kumar:
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"
1
(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).
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 approvals in the device master record (21 CFR 820.181).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
2
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,
Ronald P. Jean -S
for 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
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Indications for Use
510(k) Number (if known) K230325
Device Name
GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System
Indications for Use (Describe)
The GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is a pedicle screw fixation system intended for 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: · Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and
radiographic studies)
- · Spondylolisthesis
- · Trauma (e.g., fracture or dislocation)
- · Deformity or curvature (e.g., scoliosis, kyphosis, and/or lordosis)
- Tumor
- · Spinal stenosis
- · Pseudarthrosis
- · Failed previous fusion
Paediatric Use:
When used for posterior non-cervical screw fixation in paediatric patients, the GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is indicated as an adjunct to treat adolescent idiopathic scoliosis. Additionally, it is intended to treat paediatric patients diagnosed with the following conditions:
- · Spondylolisthesis
- · Spondylolysis
- · Fracture caused by tumor and/or trauma.
Paediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
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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Pre-market Notification 510(k) Summary as required by Section 807.92
General Company Information as required by 807:92(a)
(a.1)The submitter's name, address, telephone number, a contact person, and the date the summary was prepared
| 510(k) submitter | : | Greens Surgicals Pvt. Ltd. |
|---|---|---|
| Head office Address | : | TF-1 E & F, Third Floor, Lotus Aura-I, |
| Near IOCL Petrol Pump, | ||
| Sama Savli Main Road, Vadodara - 390 008 | ||
| Gujarat, INDIA | ||
| Manufacturing Unit Address | : | Plot No. 508-512, Savli Industrial Estate, |
| GIDC Manjusar, Vadodara - 391 775 | ||
| Gujarat, INDIA | ||
| Contact person name | : | Dr. Vinay Kumar |
| Title | : | Director |
| Phone number | : | +91 9099757575 |
| Dated | : | 09-09-2024 |
Throughout the submission there is a mention of GREENS Brand Posterior, Non cervical Pedicle Screw Spinal System that represents the range of products covered under this 510(k) submission
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a.2: The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
Proprietary Name:
- . GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System.
Common or Usual Name:
· Thoracolumbosacral pedicle screw system
Product Code: NKB
Device Class: II
Review Panel: Orthopaedic
Regulation Name and Number: 21CFR 888.3070; Thoracolumbosacral pedicle screw system
Description of GREENS BRAND Posterior, Non cervical Pedicle Screw Spinal System
Polyaxial Screw: This screw is used in various spinal fixations in conjunction with other hardware to create a rigid construct. The polyaxial screw consists of a body, bushing, and ball head screw.
Inner screw, Rod complete the spinal construct. The body portion of the screw rotates about the ball head on the screw, which provides increased motion over a fixed post of the polyaxial screw. An increase in motion facilitates the capture of rods that are not perfectly aligned.
Straight Rods: Rods are used to connect pedicle screws and create a rigid structure.
Inner Screw: Inner screws are used to secure the bone screw and rod interface
A3) Identification of the Predicate Device:
Following are the predicate devices with which we are declaring substantial equivalence :
Primary predicate device: Stryker Xia 4.5mm Evolution Polyaxial Screw (K121342) Additional predicate devices: CD HORIZON® Multi- Axial Screw (K152457) Zimmer Vital Polyaxial Screw (K150896)
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a4). A description of the device that is the subject of the premarket notification submission,
such as might be found in the labeling or promotional material for the device
Device Description:
GREENS BRAND Posterior, Non cervical Pedicle Screw Spinal System
The posterior non-cervical pedicle screw spinal system consists of a body, bushing, and ball head screw. Inner Screw, rods complete the spinal construct. The body portion of the screw rotates about the ball head on the screw, which provides increased motion over a fixed post of the polyaxial screw. An increase in motion facilitates the capture of rods that are not perfectly aligned.
The Screws, Rods are fabricated from Titanium alloy.
These implants are supplied non-sterile; the products have to be sterilized prior to use.
A5). A statement of the intended use of the device
Indications for Use:
The GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is a pedicle screw fixation system intended for 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:
- . Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- . Spondylolisthesis
- Trauma (e.g., fracture or dislocation) .
- Deformity or curvature (e.g., scoliosis, kyphosis, and/or lordosis) .
- . Tumor
- Spinal stenosis .
- Pseudarthrosis .
- Failed previous fusion .
Paediatric Use:
When used for posterior non-cervical screw fixation in paediatric patients, the GREENS BRAND
7
Posterior, Non-cervical Pedicle Screw Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, it is intended to treat paediatric patients diagnosed with the following conditions:
- Spondylolisthesis .
- . Spondylolysis
- Fracture caused by tumor and/or trauma. .
Paediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
a6). Summary of Technological Characteristics as compared to the predicate devices:
Substantial equivalence including comparison with predicate devices
A comparison between the GREENS BRAND Posterior, Non cervical Pedicle Screw Spinal System and predicate devices has been performed which has demonstrated substantial equivalence of indications for use, material, mechanical performance, and dimensions compared to predicate devices.
b1). Discussion on the non-clinical testing performed
Following are the applicable product standards considered for non-clinical standards
A:Material Standards
B: Performance Standards
A: Material Standards
We have complied to following material standard
- ASTMF136: Standard specification for wrought Titanium-6 Aluminium-4 Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.
B: Performance Standards:
The device performance of subject devices has been demonstrated using the following performance testing:
ASTM F1717
- Static compression bending .
- Static torsion ●
- Dynamic compression bending ●
ASTM F1798
8
- Axial grip ●
- Flexion-extension .
b2). Discussion on the clinical evaluation referenced and relied upon:
Clinical information was not necessary to demonstrate substantial equivalence.
CONCLUSION:
General, Safety and Performance conclusion:
From the available data we can justify that the GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is substantially equivalent to previously cleared predicate devices identified in a3.of this 510(k) summary.