(308 days)
No
The 510(k) summary describes a system of bone plates and screws for fracture fixation. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies are based on mechanical testing of the implants.
Yes.
The device is indicated for "temporary internal fixation and stabilization of osteotomies and fractures," which describes a therapeutic function.
No
This device is a system of plates and screws intended for internal fixation and stabilization of osteotomies and fractures, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states the system utilizes screws and plates made of medical grade stainless steel and titanium, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the temporary internal fixation and stabilization of osteotomies and fractures in various bones. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device description details plates and screws made of medical-grade materials, designed for surgical implantation.
- 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 compatibility testing.
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
ARMAR™ / ARTIST™ Small Fragment and Calcaneal Plates & MBOSS™/FIXION™ Screws are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:
- comminuted fractures
- supracondylar fractures
- extra-articular fractures
- fractures in osteopenic bone
- nonunions
- malunions
Smaller-sized ARMAR™ / ARTISTM plates are used for small bones and small fragments of the hands and feet.
ARMAR™ / ARTIS™ Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneous.
ARMAR™ / ARTIS™ Humerus and Olecranon plates & MBOSS™/FIXION™ Screws are intended for fractures and fracture dislocations, osteotomnies, and non-unions of the distal and proximal humerus, olecranon, and ulna in adult, particularly in osteopenic bone.
Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distalhumerus. Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.
ARMAR™ / ARTISTM Tibia and Buttress Plates & MBOSS™/FIXION™ Screws are intended for fixation of the ankle in adults. Specifically, - Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia.
- Medial Distal and Proximal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
- L Buttress and T Buttress Plates are intended to buttress partial articular fractures . and bone fragments of the distal tibia, and
- Proximal Lateral Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia, a Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia.
ARMAR™ / ARTISTM 2.4mm Plates & MBOSS™/FIXION™ Screws are intended for Fixation of complex intra- and extra-articular fractures and osteotomnies of the distal radius and other small bones in adults.
ARMAR™ / ARTIS™ Clavical Hook Plate & MBOSS™/FIXION™ Screws is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
ARMAR™ / ARTISTM Metaphyseal Plate & MBOSS™/FIXION™ Screws indicated for fractures, osteotomies, and non-unions of the radius and other small bones. Additionally, the Metaphyseal Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula.
ARMAR™ / ARTIS™ Calcaneal Plate & MBOSS™/FIXION™ Screws is intended for fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Meril Healthcare Trauma System utilizes screws and plates of various lengths and designs to accommodate a variety of patient anatomies. The Trauma System utilizes medical grade stainless steel and titanium. Trauma System implant are provided clean and non-sterile with instructions for steam sterilization. The instruments are provided non-sterile and are reusable. The implants are provided nonsterile and are single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hands, feet, calcaneal, distal humerus, proximal humerus, olecranon, ulna, ankle, distal tibia, radius, lateral clavicle, acromioclavicular joint, pelvis, acetabulum, scapula.
Indicated Patient Age Range
Adult
Intended User / Care Setting
Prescription Use
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)
ARMAR™ / ARTISTM plates and MBOSS™/FIXION™ screws have been tested in the following test modes:
- Static Four-point Bending per ASTM F382-99 (2008)
- Dynamic Four-point Bending per ASTM F382-99 (2008)
- Static Torsion per ASTM F543-13
- Static Axial Pullout per ASTM F543-13
The results of this non-clinical testing show that the strength of the ARMAR™ / ARTIS™ plates and MBOSS™/FIXION™ screws are sufficient for their intended use and substantially equivalent to legally marketed predicate devices.
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.
K121672, K120717, K082625, K121601, K120854, K110125, K102694, K953644, K061753, K070946, K031573, K020401, K112583, K000682, K071264, K102694, K092609, K000682, K092609, K021932
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
§ 888.3030 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Meril Healthcare Pvt. Ltd. % Meredith May VP Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918 March 8, 2018
Re: K171320
Trade/Device Name: ARMAR™ / ARTIS™ Small Fragment and Calcaneal Plates & MBOSS™ / FIXION™ Screws ARMAR™ / ARTIS™ Humerus and Olecranon Plates & MBOSS™/FIXION™ Screws ARMARTM / ARTISTM Tibia and Buttress Plates & MBOSS™/FIXION™ Screws ARMAR™ / ARTIS™ 2.4mm Plates & MBOSS™/FIXION™ Screws ARMAR™ / ARTIS™ Clavical Hook Plate & MBOSS™/FIXION™ Screws ARMAR™ / ARTIS™ Metaphyseal Plate & MBOSS™/FIXION™ Screws ARMAR™ / ARTIS™ Calcaneal Plate & MBOSS™/FIXION™ Screws 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: January 30, 2018 Received: January 31, 2018
Dear Ms. May:
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.
1
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| See PRA Statement on last page. | |
| Indications for Use | |
| 510(k) Number (if known) | K171320 |
| Device Name | ARMAR™ / ARTIST™ Small Fragment and Calcaneal Plates & MBOSS™/FIXION™ Screws |
| Indications for Use (Describe) | |
| ARMAR™ / ARTIST™ Small Fragment and Calcaneal Plates & MBOSS™/FIXION™ Screws are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as: comminuted fracturessupracondylar fracturesextra-articular fracturesfractures in osteopenic bonenonunionsmalunions Smaller-sized ARMAR™ / ARTIST™ plates are used for small bones and small fragments of the hands and feet. | |
| ARMAR™ / ARTIST™ Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneous. | |
| Type of Use (Select one or both, as applicable) | |
| 区 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) | |
| FORM FDA 3881 (9/13) | |
| Page 1 of 1 | PSC Publishing Services (301) 443-6740 |
| EF | |
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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page. |
| ------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number (if known) | K171320 |
|---|---|
| Device Name | ARMARTM / ARTISTM Humerus and Olecranon Plate & MBOSSTM/FIXIONT™ Screws |
| Indications for Use (Describe) |
ARMARTM / ARTIST™ Humerus and Olecranon plates & MBOSSTM/FIXIONT™ Screws are intended
for fractures and fracture dislocations, osteotomnies, and non-unions of the distal and proximal
humerus, olecranon, and ulna in adult, particularly in osteopenic bone.
Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted
supracondylar fractures, osteotomies, malunions and non-unions of the distalhumerus. Olecranon and
Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the
olecranon and proximal ulna.
| 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) |
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)
| FORM FDA 3881 (9/13) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------- |
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."
4
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page. |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | |
| 510(k) Number (if known) | K171320 |
| Device Name | ARMARTM / ARTISTM Tibia and Buttress Plates & MBOSS™/FIXION™ Screws |
| Indications for Use (Describe) | ARMAR™ / ARTIST™ Tibia and Buttress Plates & MBOSS™/FIXION™ Screws are intended for fixation of the ankle in adults. Specifically, Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia.Medial Distal and Proximal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,L Buttress and T Buttress Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, andProximal Lateral Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia, a Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia. |
| 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) | |
| 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) | |
| FORM FDA 3881 (9/13)
Page 1 of 1 | PSC Publishing Services (301) 443-6740
EF |
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. "
5
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page. |
| ------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number ( if known ) | K171320 |
|---|---|
| Device Name | ARMAR TM / ARTIS TM 2.4mm Plates & MBOSS TM /FIXION TM Screws |
| Indications for Use (Describe) |
ARMARTM / ARTISTM 2.4mm Plates & MBOSSTM/FIXIONTM Screws are intended for Fixation of
complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones
in adults.
| 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) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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) | |
|---|---|
| ------------------------------------------------------------------------------ | -- |
| FORM FDA 3881 (9/13)
Page 1 of 1 | PSC Publishing Services (301) 443-6740
EF |
| ------------------------------------- | ---------------------------------------------- |
|---|
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. "
6
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | Form Approved: OMB No. 0910-0120 |
|---|---|
| Expiration Date: January 31, 2017 | |
| Indications for Use | See PRA Statement on last page. |
| 510(k) Number (if known) | K171320 |
| Device Name | ARMARTM / ARTISTM Clavical Hook Plate & MBOSS™/FIXION™ Screws |
| Indications for Use (Describe) | ARMARTM / ARTISTM Clavical Hook Plate & MBOSS™/FIXION™ Screws is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. |
| 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) |
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) | |
|---|---|
| ------------------------------------------------------------------------------ | -- |
| FORM FDA 3881 (9/13)
Page 1 of 1 | PSC Publishing Services (301) 443-6740
EF |
| ------------------------------------- | ---------------------------------------------- |
|---|
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. "
7
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | |||
|---|---|---|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 | |||
| Indications for Use | See PRA Statement on last page. | |||
| 510(k) Number (if known) | ||||
| K171320 | ||||
| Device Name | ||||
| ARMAR™ / ARTIS™ Metaphyseal Plate & MBOSS™/FIXION™ Screws | ||||
| Indications for Use (Describe) | ||||
| ARMAR™ / ARTIS™ Metaphyseal Plate & MBOSS™/FIXION™ Screws indicated for fractures, | ||||
| osteotomies, and non-unions of the radius and other small bones. Additionally, the Metaphyseal Plate | ||||
| is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, | ||||
| clavicle, and scapula. | ||||
| Type of Use (Select one or both, as applicable) | ||||
| 2 Prescription Use (Part 21 CFR 801 Subpart D) | ||||
| 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) | ||||
| FORM FDA 3881 (9/13) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | ||
| EF | ||||
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
8
information unless it displays a currently valid OMB number.
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| See PRA Statement on last page. | |
| Indications for Use | |
| 510(k) Number (if known) | K171320 |
| Device Name | ARMAR TM / ARTIST TM Calcaneal Plate & MBOSS TM /FIXION TM Screws |
| Indications for Use (Describe) | |
| ARMAR TM / ARTIST TM Calcaneal Plate & MBOSS TM /FIXION TM Screws is intended for fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus. | |
| 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) |
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)
| FORM FDA 3881 (9/13) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
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."
9
| Submitter's Name | Meril Healthcare Pvt. Ltd. |
|---|---|
| Submitter's Address | First Floor, H1-H3, Meril Park, |
| Survey No. 135/2/B & 174/2, | |
| Muktanand Marg, Chala, Vapi-396191 | |
| Gujarat, India | |
| Submitter's Telephone | 352-377-1140 |
| Submitter Contact | Umesh Sharma |
| umesh.sharma@merillife.com | |
| Contact Person | Meredith May |
| 719-337-7579 | |
| VP, Empirical Consulting | |
| Date Summary was | |
| Prepared | 24th July 2017 |
| Trade or Proprietary Name | ARMARTM / ARTIST™ Small Fragment and |
| Calcaneal Plates & MBOSS™ / FIXIONT™ Screws | |
| ARMARTM / ARTISTM Humerus and Olecranon | |
| Plates & MBOSSTM/FIXIONT™ Screws | |
| ARMARTM / ARTISTM Tibia and Buttress Plates & | |
| MBOSSTM/FIXIONTM Screws | |
| ARMARTM / ARTISTM 2.4mm Plates & | |
| MBOSSTM/FIXIONT™ Screws | |
| ARMARTM / ARTISTM Clavical Hook Plate & | |
| MBOSSTM/FIXIONT™ Screws | |
| ARMARTM / ARTIST™ Metaphyseal Plate & | |
| MBOSSTM/FIXIONTM Screws | |
| ARMARTM / ARTISTM Calcaneal Plate & | |
| MBOSSTM/FIXIONTM Screws | |
| Common or Usual Name | Plate, Fixation, Bone |
| Screw, Fixation, Bone | |
| Classification | Class II per 21 CFR §888.3030 |
| Class II per 21 CFR §888.3040 | |
| Product Code | HRS, HWC |
| Classification Panel | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: I.
The Meril Healthcare Trauma System utilizes screws and plates of various lengths and designs to accommodate a variety of patient anatomies. The Trauma System utilizes medical grade stainless steel and titanium. Trauma System implant are provided clean and non-sterile with instructions for steam sterilization. The instruments are provided non-sterile and are reusable. The implants are provided nonsterile and are single use only.
10
II. INDICATIONS FOR USE
1. ARMAR™ / ARTIS™ Small Fragment and Calcaneal Plates & MBOSS™ / FIXION™ Screws
ARMAR™ / ARTIS™ Small Fragment and Calcaneal Plates & MBOSS™/FIXION™ Screws are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:
- . comminuted fractures
- supracondylar fractures ●
- extra-articular fractures
- fractures in osteopenic bone
- nonunions
- malunions
Smaller-sized ARMAR™ / ARTISTM plates are used for small bones and small fragments of the hands and feet.
ARMARTM / ARTIS™ Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneous.
2. ARMAR™ / ARTISTM Humerus and Olecranon Plates દ્ધ MBOSS™/FIXION™ Screws
ARMAR™ / ARTIS™ Humerus and Olecranon plates & MBOSS™/FIXION™ Screws are intended for fractures and fracture dislocations, osteotomnies, and non-unions of the distal and proximal humerus, olecranon, and ulna in adult, particularly in osteopenic bone.
Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distalhumerus. Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.
3. ARMARTM / ARTISTM Tibia and Buttress Plates & MBOSS™/FIXION™ Screws
ARMARTM / ARTISTM Tibia and Buttress Plates & MBOSS™/FIXION™ Screws are intended for fixation of the ankle in adults. Specifically,
- . Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia.
- . Medial Distal and Proximal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
- L Buttress and T Buttress Plates are intended to buttress partial articular fractures . and bone fragments of the distal tibia, and
- Proximal Lateral Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia, a Distal Tibia T Plates and
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Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia.
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- ARMAR™ / ARTISTM 2.4mm Plates & MBOSS™/FIXION™ Screws ARMAR™ / ARTIS™ 2.4mm Plates & MBOSS™/FIXION™ Screws are intended for Fixation of complex intra- and extra-articular fractures and osteotomnies of the distal radius and other small bones in adults.
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- ARMARTM / ARTISTM Clavical Hook Plate & MBOSS™/FIXION™ Screws ARMAR™ / ARTIS™ Clavical Hook Plate & MBOSS™/FIXION™ Screws is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
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- ARMAR™ / ARTISTM Metaphyseal Plate & MBOSS™/FIXION™ Screws ARMARTM / ARTISTM Metaphyseal Plate & MBOSS™/FIXION™ Screws indicated for fractures, osteotomies, and non-unions of the radius and other small bones. Additionally, the Metaphyseal Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula.
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- ARMAR™ / ARTISTM Calcaneal Plate & MBOSS™/FIXION™ Screws ARMARTM / ARTIS™ Calcaneal Plate & MBOSS™/FIXION™ Screws is intended for fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.
III. TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are similar between the subject and predicates:
- Indications for use ●
- Materials of manufacture
- Structural support mechanism ●
- Principle of operation ●
- Sizes ●
| 510k Number | Trade or Proprietary or Model
Name | Manufacturer | Predicate
Type |
|------------------------------|---------------------------------------|--------------|-------------------|
| K143331, K083654 | Bone Plates | Zimmer | Primary |
| K121672, K120717,
K082625 | Plate System | Synthes | Additional |
| K121601, K120854 | Ankle Trauma System | Synthes | Additional |
| K110125, K102694,
K953644 | Distal Radius System | Synthes | Additional |
| K061753 | Clavicle Hook Plate | Synthes | Additional |
Table 5-1: Predicate Devices
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| K070946, K031573 | Pelvic Plates | Synthes | Additional |
|---|---|---|---|
| K020401 | Calcaneal Plate | Synthes | Additional |
| K112583, K000682 | Cortical Screws and DCL | ||
| System | Synthes | Additional | |
| K071264, K102694, | |||
| K092609, K000682 | Foot and Ankle Plates | Synthes | Additional |
| K092609, K021932 | Cancellous Screws | Synthes | Additional |
IV. PERFORMANCE DATA
ARMAR™ / ARTISTM plates and MBOSS™/FIXION™ screws have been tested in the following test modes:
- Static Four-point Bending per ASTM F382-99 (2008) ●
- Dynamic Four-point Bending per ASTM F382-99 (2008) .
- Static Torsion per ASTM F543-13 ●
- Static Axial Pullout per ASTM F543-13 ●
The results of this non-clinical testing show that the strength of the ARMAR™ / ARTIS™ plates and MBOSS™/FIXION™ screws are sufficient for their intended use and substantially equivalent to legally marketed predicate devices.
V. CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the ARMAR™ / ARTIS™ plates and MBOSS™/FIXION™ screws are substantially equivalent to the predicate devices.