(147 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and design of a spinal implant system, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
This device is a pedicle screw spinal system used as an adjunct to fusion for treating spinal instabilities and deformities, which is a structural implant rather than a therapeutic device.
No
The device is a pedicle screw spinal system, intended for use as an adjunct to fusion in the treatment of various spinal instabilities and deformities. It is an implant used for physical support and treatment, not for diagnosing conditions.
No
The device description clearly outlines physical components made of Titanium (screws, rods, transverse connectors) and discusses their dimensions and mechanical properties. There is no mention of software as the primary or sole component.
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 provided text describes a surgical implant system (pedicle screws, rods, connectors) used to stabilize the spine during fusion procedures. It is physically implanted into the patient's body.
- Intended Use: The intended use clearly states it's for treating instabilities and deformities in the noncervical spine as an adjunct to fusion. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a spinal implant, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is intended for use in the noncervical spine. The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is used as an adjunct to fusion, using autograft or allograft, in the treatment of the following instabilities and deformities in skeletally mature patients:
- Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of disc confirmed by history & radiographic studies)
- Spondylolisthesis
- Trauma (Fracture or Dislocation)
- Spinal Stenosis
- Scoliosis, Kyphosis and/or lordosis
- Pseudoarthrosis
- Failed Previous Fusion
The system is indicated for use in adult patients only. All implants are for single use only.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The Monoaxial & Polyaxial screw consists of a body, bushing, and ball head screw. Inner Screw, rods and transverse connectors assemblies 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 or monoaxial screw. An increase in motion facilitates the capture of rods that are not perfectly aligned.
The Screws, Rods & Transverse Connectors are fabricated from Titanium.
The system contains several models based on the size of the device and application site such as fixation/reconstruction spine.
- . Single Lock Monoaxial Screw
- Single Lock Polyaxial Screw ●
- Transverse connector
- Rod
The diameter of these screw varies from 4mm to 7mm with length 25mm to 50mm.
The corresponding connector are small & large in size.
The diameter of Rod is 5.5mm with length 75mm to 150mm
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
noncervical spine
Indicated Patient Age Range
skeletally mature patients
adult patients only
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 was performed against ASTM F 1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. The compliance to these standards was verified.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2017
GPC Medical Limited Mr. Vikas Narang Director-Exports GPC Square, M-Block, DDA, LSC, Vikas Puri New Delhi, 110018 INDIA
Re: K163096
Trade/Device Name: GPC 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: February 20, 2017 Received: February 23, 2017
Dear Mr. Narang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163096
Device Name
GPC Brand Posterior, Non cervical Pedicle Screw Spinal System
Indications for Use (Describe)
The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is intended for use in the noncervical spine. The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is used as an adjunct to fusion, using autograft or allograft, in the treatment of the following instabilities and deformities in skeletally mature patients.
- Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of disc confirmed by history & radiographic studies)
-
- Spondylolisthesis
-
- Trauma (Fracture or Dislocation)
-
- Spinal Stenosis
-
- Scoliosis, kyphosis and/or lordosis
-
- Pseudoarthrosis
-
- Failed Previous Fusion
The system is indicated for use in adult patients only. All implants are for single use only.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Premarket 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
201102
| Submitter's Name: | GPC Medical Limited |
|---|---|
| Address: | Office: |
| GPC Square, M Block, DDA LSC, Vikas Puri, New | |
| Delhi 110018 India | |
| Factory: | |
| A-82, Sector A-4, Tronica City, Loni, Ghaziabad, Uttar Pradesh |
ContactPersonName: Mr. Vikas Narang Title: Director-Exports Phone Number: +91-9810638797 Dated: March 30, 2017
Throughout the submission, there is a mention of GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System that represents the range of products covered under this 510(k) submission
4
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
ProprietaryName:
- . GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System.
| ProductCode: | """""NKB |
|---|---|
| Device Class: | II |
| ReviewPane: | Orthopaedic |
Regulation Number:
Variants/Types: GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System are further subdividedintofollowing categories
| S.No. | Category | Variants |
|---|---|---|
| 01 | Single Lock Monoaxial Screw (with inner screw) | MAS42 and SPS42 |
| 02 | Single Lock Polyaxial Screw (with inner screw) | MAS44 and SPS44 |
| 03 | Transverse Connector | No variants |
| 04 | Rod | No variants |
5
A3) Identification of the Predicate Device:
Following are the predicate device 510(k) with which we are declaring substantial equivalence:
| S. No. | Subject Device | Primary Predicate | Additional Predicates |
|---|---|---|---|
| 01 | GPC BRAND Posterior, | ||
| Non cervical Pedicle | |||
| Screw Spinal System | Zodiac Polyaxial Spinal Fixation | ||
| System (K100685) | Scient'X MX Monoaxial Pedicle | ||
| Screw System (K042964) |
a4).A description of the device that is the subject to the premarket notification submission, such as might be found in the labeling or promotional material for the device
Device Description:
GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System
The Monoaxial & Polyaxial screw consists of a body, bushing, and ball head screw. Inner Screw, rods and transverse connectors assemblies 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 or monoaxial screw. An increase in motion facilitates the capture of rods that are not perfectly aligned.
The Screws, Rods &Transverse Connectors are fabricated from Titanium.
The system contains several models based on the size of the device and application site such as fixation/reconstruction spine.
- . Single Lock Monoaxial Screw
- Single Lock Polyaxial Screw ●
- Transverse connector
- Rod
The diameter of these screw varies from 4mm to 7mm with length 25mm to 50mm.
The corresponding connector are small & large in size.
The diameter of Rod is 5.5mm with length 75mm to 150mm
These implants are supplied non-sterile; the products have to be sterilized prior to use.
Further Description of GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System
6
Monoaxial Bone Screw: This screw is used in various spinal fixations in conjunction with otherhardware to create a rigid construct. The monoaxial screw consists of a body and ball head screw.
Polyaxial Bone 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 and transverse connector assemblies 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 or monoaxial screw. An increase in motion facilitates the capture of rods that are not perfectly aligned. Inner screws are used to secure the bone screw and rod interface
Straight Rods: Rods are used to connect pedicle screws and create a rigid structure.
Transverse Connectors: Connectors are used to connect to rods together to create a more rigid construct.
The diameter of these screw varies from 4mm to 7mm with length 25mm to 50mm.
The corresponding connector are small & large in size.
The diameter of Rod is 5.5mm with length ranging from 75mm to 150mm
The inner screw is of standard size throughout the range of monoaxial and polyaxial screws.
Sizes of the Subject Devices for both Design I & Design II:
Transverse Connector: Design I and Design II
Straight Rod:
5.5mm Dia:75mm, 80mm, 100mm, 125mm, 150mm
Monoaxial screw:
4.5mm Dia: 25mm, 30mm, 35mm, 40mm, 45mm, 50mm
5.5mm Dia: 25mm, 30mm, 35mm, 40mm, 45mm, 50mm
6.0mm Dia: 25mm, 30mm, 35mm, 40mm, 45mm, 50mm
7.0mm Dia: 25mm, 30mm, 35mm, 40mm, 45mm, 50mm
Polyaxial Screws:
7
4.5mm Dia: 25mm, 30mm, 35mm, 40mm, 45mm, 50mm
5.5mm Dia: 25mm, 30mm, 35mm, 40mm, 45mm, 50mm
6.0mm Dia: 25mm, 30mm, 35mm, 40mm, 45mm, 50mm
7.0mm Dia: 25mm. 30mm. 35mm. 40mm. 45mm. 50mm
A5).(5)A statement of the intended use of the device
Indications for Use:
The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is intended for use in the noncervical spine. The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is used as an adjunct to fusion, using autograft or allograft, in the treatment of the following instabilities and deformities in skeletally mature patients:
-
- Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of disc confirmed by history & radiographic studies)
-
- Spondylolisthesis
-
- Trauma (Fracture or Dislocation)
-
- Spinal Stenosis
-
- Scoliosis, Kyphosis and/or lordosis
-
- Pseudoarthrosis
-
- Failed Previous Fusion
The system is indicated for use in adult patients only. All implants are for single use only.
a6). Summary of Technological Characteristics as compared to the predicate devices:
Substantial equivalence including comparison with predicate devices
A comparison between the GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System
And predicate devices has been performed which has resulted in demonstration of similarities in dimensional and performance criteria.
8
Following is the summary of parameters in which the comparison has been verified:
| S.No. | Characteristics | Predicate Device Versus New
Device (GPCBrand) | Remarks |
|-------|-----------------------------|----------------------------------------------------------------------------------------|------------|
| 01 | Indications for use | Similar intended use in New Device
and Predicate device | Equivalent |
| 02 | Material | Same material used in New Device and
Predicate device | Equivalent |
| 03 | Performance
Standards | Same performance standards used in both
New Device as well as predicate device | Equivalent |
| 04 | Sterilization | Same method of sterilization used in
both New Device as well as Predicate
device | Equivalent |
| 05 | Dimensional
Verification | Same dimensions found in both New
Device as well as Predicate device. | Equivalent |
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:
The material standards are the essential part to be complied to first, as it is the basis of manufacturing metallic surgical implants.
We have complied to following material standards
-
- ASTMF136:Standard specification for wrought Titanium-6Aluminium-4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.
9
B:Performance Standards:
The device performance of GPC BRAND Pedicle Screw System has been demonstrated against following applicable standards
- ASTM F 1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
We have verified the compliance to these standards and copies of the relevant test results were provided in the submission.
b2). Discussion on the clinical evaluation referenced and relied upon:
GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System are of similar design and pattern as well as similar intended use. Clinical information was not necessary to demonstrate substantial equivalence.
CONCLUSION:
General, Safety and Performance conclusion:
From the available data available we can justify that the GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System are as safe, as effective and perform as same indications for use as that of already marketed predicate devices identified in a3.of 510(k) summary.
Hence this system can be considered substantially equivalent to the identified predicates.