(145 days)
No
The device description and performance studies focus solely on the mechanical properties and dimensions of bone plates and screws, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "Osteosynthesis Plating System" indicated "for treating fractures of various bones", which directly addresses a medical condition to restore function and mitigate symptoms.
No
Explanation: The device is an osteosynthesis plating system, which is used for treating fractures and providing mechanical support, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical components (plates and screws fabricated from Stainless Steel and Titanium) and does not mention any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for treating bone fractures through osteosynthesis (surgical fixation of bones). This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details physical implants (plates and screws) made of metal, designed to be surgically inserted to stabilize bone fractures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).
The system is indicated for use in adult patients only. All implants are for single use only.
Product codes
HRS, HWC
Device Description
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws.
The plates and screws are fabricated from Stainless Steel and Titanium.
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System contains several models based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in many models available: like, Reconstruction Plates, T-Plates, Anatomical Plates and Clavicle Hook Plates.
These all are mainly divided into
- Large Fragment Plates
- . Small Fragment Plates
- Mini Fragment Plates
The number of the holes varies from 2 to 22.
The Locking screw implants are in corresponding diameter ranges from 2.4mm, 3.5mm, 5.0mm and 6.5mm diameters with lengths varying as per the requirements and minimum length: 20 mm to maximum length 150mm
The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 140mm. The non locking screws 3.5mm and 4.5mm were cleared previously in 510k number K092493
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
clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges)
Indicated Patient Age Range
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)
The performance of the plates was demonstrated using an engineering analysis of bending moment and bending stiffness based on material properties and the plate shaft dimensions.
The performance of the screws was demonstrated using an engineering analysis of pull-out strength and torque-to-failure based on material properties and the screw dimensions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K082807, K051986, K030858, K023802, K030597, K983787, K062564, K000684, K030597, K011978, K092812, K061753, K041860, K062494, K033995, K001945, K041860, K982732, K012114, K040777, K033975, K051567, K000684, K051567, K000684, K051567, K000682, K051567, K021932, K051567
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, representing the department's focus on health and human well-being. The profiles are depicted in a simple, abstract manner.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2016
GPC Medical Limited Mr. Vikas Narang Director-Exports M-Block, DDA LSC, Vikas Puri New Delhi, 110018 INDIA
Re: K153716 Trade/Device Name: GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: April 8, 2016 Received: April 11, 2016
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
1
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
forth in 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
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) K153716
Device Name
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
Indications for Use (Describe)
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for treating fractures of various bones including the clavic, scapula, long bone ( humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).
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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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
Submitter's Name:
GPC Medical Ltd.
Address:
Office:
M Block, DDA LSC, Vikas Puri, New Delhi 110018 India
Factory: A-82, Sector A-4, Tronica City, Loni, Ghaziabad, Uttar Pradesh 201102
| Contact Person Name: | Mr. Vikas Narang |
|---|---|
| Title: | Director-Exports |
| Phone Number: | +91-9810638797 |
| Dated: | 21-12-2015 |
This is a bundled submission.
Throughout the submission there is a mention of GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating 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
Proprietary Name:
-
. GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
Common or Usual Name: -
Orthopaedic Bone Plates
-
Orthopaedic Bone Screws
Classification Name:
- PLATES, FIXATION, BONE
- · SCREWS, FIXATION, BONE
| Product Code: | HRS, HWC |
|---|---|
| Device Class: | II |
| Review Pane: | Orthopaedic |
| Regulation Number: | 21 CFR 888.3030 and 21 CFR 888.3040 |
| Variants/Types: | GPC BRAND Locking Bone Plates and Screws Osteosynthesis |
| Plating System are further subdivided into following categories |
| S. No. | Category | Types |
|---|---|---|
| 01 | Large Fragment Plates | Locking Version |
| 02 | Small Fragment Plates | Locking Version |
| 03 | Mini Fragment Plates | Locking Version |
| 04 | Bone Screws | Locking and Non-Locking |
| Version |
5
Further Description of GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
Generally there are following types of bone plates used with cortical (cortex) and Locking Screws. These bone plates are generally designed on the basis of the boñe contour and anatomy.
| S. No. | Type | Subtype |
|---|---|---|
| 01 | Small and Large | |
| Fragment | T-Shaped, Hook Angled Plates. Reconstructions plates | |
| 02 | Dynamic compression | Small DCP, Narrow DCP, Lengthening Narrow, Broad |
| DCP, Lengthening Broad Plates | ||
| 03 | Mini Fragment | T-Shaped |
6
A3) Identification of the Predicate Device:
Following are the predicate device 510(k) with which we are declaring substantial equivalence:
Following is the range of variants covered with their corresponding predicate devices.
| S. No. | Subject Device | Predicate Device |
|---|---|---|
| 01 | 4.5mm Narrow Locking Plate | Synthes 3.5 and 4.5mm Locking |
| Compression Plate System (K082807) | ||
| 02 | 4.5mm Broad Locking Plate | Synthes 3.5 and 4.5mm Locking |
| Compression Plate System (K082807) | ||
| 03 | 4.5mm/5.0mm Broad Curved Locking Plate | Synthes 3.5 mm and 4.5 mm |
| Curved Narrow and Broad Locking | ||
| Compression Plates (K082807) | ||
| 04 | 4.5mm Reconstruction Locking Plate | Synthes 4.5 mm LCP Straight |
| Reconstruction Plate (K051986) | ||
| 05 | Proximal Femur Locking Plate | Synthes (USA) LCP Proximal Femur |
| Plate (K030858) | ||
| 06 | Locking Lateral Proximal Tibia Plate, Left | |
| and Right | Synthes LCP Proximal Tibia | |
| Plate (K023802, K030597, K983787) | ||
| 07 | 4.5mm Distal Femur Locking Plate, Left and | |
| Right | Synthes LCP Distal Femur | |
| Plates (K062564) | ||
| 08 | Locking T-Plate 3.5mm, Oblique Angled, Left | |
| and Right | Synthes Small Fragment Dynamic | |
| Compression Locking( DCL) System | ||
| (K000684) | ||
| 09 | Small Dynamic Compression Plate 3.5mm with | |
| LC Under Cuts | Synthes 3.5 (USA) Locking | |
| Compression Plate System (K082807) | ||
| 10 | 3.5mm Small 'T' Plate – 3 Head Holes | Synthes Small Fragment Dynamic |
| Compression Locking( DCL) | ||
| System(K000684) | ||
| 11 | 3.5mm Small 'T' Plate – 4 Head Holes | Synthes Small Fragment Dynamic |
| Compression Locking(DCL) | ||
| System(K000684) | ||
| 12 | Proximal Tibia Locking Plate, Left and Right | Synthes 3.5mm Titanium LCP |
| Proximal Tibia Plate (K030597) OR | ||
| Synthes LCP Proximal Tibia Plates | ||
| (K011978) | ||
| 13 | Locking Anterolateral Tibia Distal Plate 3.5mm | Synthes (USA) LCP Anterolateral |
| Distal Tibia Plate 3.5 (K092812) | ||
| 14 | Locking Clavicle Hook Plate 3.5mm, Left and Right | Synthes Clavicle Hook Plate |
| (K061753) | ||
| 15 | 3.5mm Proximal Humerus Locking Plate | Proximal humerus plate long |
| Synthes K041860 |
K062494 EBI Optilock Upper
Extremity Plating System |
| 16 | Distal Humerus Locking Plate, Size 2.7/3.5mm,
Left and Right | Synthes 3.5mm LCP Distal
Humerus System (K033995) |
| 17 | Distal Humerus Locking Plate, 2.7/3.5mm with
Lateral Support, Left and Right | Synthes 3.5mm LCP Distal
Humerus System (K033995) |
| 18 | Locking Medial Distal Tibia Plate without Tab,
Left and Right | Synthes Medial Distal Tibia Plate
(K001945) |
| 19 | Locking Philous Plate | Synthes (USA) LCP® Proximal
Humerus Plates, Long (K041860) |
| 20 | 'T' Distal Radius 2.4mm Locking Plate | K982732 or K012114 (Synthes locking
distal radius plating system) |
| 21 | Locking Distal Radius Buttress Plate 2.4mm | Synthes (USA) LCP Radial Head Plating
System (K040777) |
| 22 | Self Tapping Locking Screw 2.4mm | Synthes 2.4mm Titanium locking
screw (K033975)
K051567 APTUS Titanium Fixation
System |
| 23 | Self Tapping Locking Screw 2.7mm | Synthes Small Fragment Dynamic
Compression Locking (DCL) System
(K000684)
K051567 APTUS Titanium Fixation
System |
| 24 | Self Tapping Locking Screw 3.5mm | Synthes Small Fragment Dynamic
Compression Locking (DCL) System
(K000684)
K051567 APTUS Titanium Fixation
System |
| 25 | Self Tapping Locking Screw 5.0mm | Synthes Large Fragment Dynamic
Compression Locking (DCL) System
(K000682)
K051567 APTUS Titanium Fixation
System |
| 26 | 6.5mm Self Tapping Locking Cannulated
Screw | Synthes Cannulated Screw System
K021932
K051567 APTUS Titanium Fixation
System |
7
8
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:
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws.
The plates and screws are fabricated from Stainless Steel and Titanium.
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System contains several models based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in many models available: like, Reconstruction Plates, T-Plates, Anatomical Plates and Clavicle Hook Plates.
These all are mainly divided into
- Large Fragment Plates
- . Small Fragment Plates
- Mini Fragment Plates ●
The number of the holes varies from 2 to 22.
The Locking screw implants are in corresponding diameter ranges from 2.4mm, 3.5mm, 5.0mm and 6.5mm diameters with lengths varying as per the requirements and minimum length: 20 mm to maximum length 150mm
The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 140mm. The non locking screws 3.5mm and 4.5mm were cleared previously in 510k
Rev: 02 SECTION 5 Date: 27.04.2016 PAGE 6 OF 10
9
number K092493
These implants are supplied non-sterile, the products have to be sterilized prior to use.
10
A5). (5) A statement of the intended use of the device
Indications for Use:
· GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are provided nonsterile.
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).
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 Locking Bone Plates and Screws Osteosynthesis Plating System and predicate devices has been performed which has resulted in demonstration of similarities in dimensional and performance criteria.
| S. No. | Characteristics | Predicate Device Versus New
Device (GPC Brand) | 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 |
Following is the summary of parameters in which the comparison has been verified:
11
b1). Discussion on the non-clinical testing performed
Following are the applicable product standards considered for non-clinical standards
Material A: Standards
B: Performance Standards
Material A: 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
-
- ASTM F 136: Standard specification for wrought Titanium-6Aluminium-4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.
-
- ASTM F 138: Standard Specification for Wrought 18 chromium-14Nickel-2.5Molybdenum stainless steel bar and wire for surgical implants.
-
- ASTM F 139: Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants
We have verified the purchased material compliance to these standards and copies of the relevant test results were provided in the submission.
The performance of the plates was demonstrated using an engineering analysis of bending moment and bending stiffness based on material properties and the plate shaft dimensions.
The performance of the screws was demonstrated using an engineering analysis of pull-out strength and torque-to-failure based on material properties and the screw dimensions.
12
b2). Discussion on the clinical evaluation referenced and relied upon:
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating 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 Locking Bone Plates and Screws Osteosynthesis Plating 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 these devices can be considered safe and effective for their intended use.