ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws
Device Facts
| Record ID | K171320 |
|---|---|
| Device Name | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws |
| Applicant | Meril Healthcare Pvt. , Ltd. |
| Product Code | HRS · Orthopedic |
| Decision Date | Mar 8, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
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. ARMAR™ / ARTISTM 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™ / 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. ARMAR™ / ARTIS™ Clavical Hook Plate & MBOSS™/FIXION™ Screws is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. 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. ARMAR™ / ARTIS™ Calcaneal Plate & MBOSS™/FIXION™ Screws is intended for fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.
Device Story
Trauma system consisting of medical-grade stainless steel and titanium plates and screws; used for internal fixation and stabilization of bone fractures, osteotomies, and non-unions. Implants provided non-sterile; require steam sterilization by user. Used in clinical settings by orthopedic surgeons to provide structural support to bone fragments during healing. Output is physical stabilization of bone; clinical decision-making based on radiographic assessment of fracture type and anatomical location. Benefits include restoration of bone alignment and support for healing.
Clinical Evidence
Bench testing only. Testing included static and dynamic four-point bending (ASTM F382-99), static torsion (ASTM F543-13), and static axial pullout (ASTM F543-13). Results demonstrate mechanical strength sufficient for intended use.
Technological Characteristics
Materials: medical-grade stainless steel and titanium. Principle: internal bone fixation via plates and screws. Sterilization: steam sterilization (implants provided non-sterile). Form factor: various lengths and designs for specific anatomical sites.
Indications for Use
Indicated for temporary internal fixation and stabilization of fractures, osteotomies, nonunions, and malunions in adults, including small bones (hands/feet/radius), humerus, olecranon, ulna, tibia, calcaneus, clavicle, pelvis, and acetabulum. Includes use in osteopenic bone.
Regulatory Classification
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.
Predicate Devices
- Zimmer Bone Plates (K143331, K083654)
- Synthes Plate System (K121672, K120717, K082625)
- Synthes Ankle Trauma System (K121601, K120854)
- Synthes Distal Radius System (K110125, K102694, K953644)
- Synthes Clavicle Hook Plate (K061753)
- Synthes Pelvic Plates (K070946, K031573)
- Synthes Calcaneal Plate (K020401)
- Synthes Cortical Screws and DCL System (K112583, K000682)
- Synthes Foot and Ankle Plates (K071264, K102694, K092609, K000682)
- Synthes Cancellous Screws (K092609, K021932)
Related Devices
- K190430 — OsteoCentric Bone Plate and Screw System · Osteocentric Trauma · Mar 22, 2019
- K241599 — Signature Osteosynthesis Plate System · Signature Orthopaedic Pty , Ltd. · Feb 6, 2025
- K192619 — Pitkar Locked Plating System · S.H.Pitkar Orthotools Pvt. , Ltd. · Feb 27, 2020
- K170518 — In2Bones Fracture and Correction System · In2bones USA, LLC · Jul 14, 2017
- K181843 — MLP Special Locking Bone Plate System · Maxxion Medical, LLC / Baumer SA · Mar 4, 2019
Submission Summary (Full Text)
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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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | Expiration Date: January 31, 2017<br>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: <ul><li>comminuted fractures</li><li>supracondylar fractures</li><li>extra-articular fractures</li><li>fractures in osteopenic bone</li><li>nonunions</li><li>malunions</li></ul> 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) | |
| | <span>区</span> Prescription Use (Part 21 CFR 801 Subpart D) <span>☐</span> 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)<br>Page 1 of 1 | PSC Publishing Services (301) 443-6740<br>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<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>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) | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <span style="display:inline-block; margin-right: 5px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) <span style="display:inline-block; margin-left: 20px;">☐</span> 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<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>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, <ul><li>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.</li><li>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,</li><li>L Buttress and T Buttress Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and</li><li>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.</li></ul> |
| Type of Use (Select one or both, as applicable) | |
| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) <input type="checkbox"/> 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)<br>Page 1 of 1 | PSC Publishing Services (301) 443-6740<br>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<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement on last page. |
|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
**Indications for Use**
| 510(k) Number ( <i>if known</i> ) | K171320 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------|
| Device Name | ARMAR <sup>TM</sup> / ARTIS <sup>TM</sup> 2.4mm Plates & MBOSS <sup>TM</sup> /FIXION <sup>TM</sup> Screws |
| Indications for Use (Describe) | |
ARMAR<sup>TM</sup> / ARTIS<sup>TM</sup> 2.4mm Plates & MBOSS<sup>TM</sup>/FIXION<sup>TM</sup> 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) | <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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)<br>Page 1 of 1 | PSC Publishing Services (301) 443-6740<br>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<br>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) | |
| <div style="display:inline-block;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:inline-block;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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)<br>Page 1 of 1 | PSC Publishing Services (301) 443-6740<br>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)<br>K171320 | | | | |
| Device Name | | | | |
| ARMAR™ / ARTIS™ Metaphyseal Plate & MBOSS™/FIXION™ Screws<br>Indications for Use (Describe) | | | | |
| | | | | |
| ARMAR™ / ARTIS™ Metaphyseal Plate & MBOSS™/FIXION™ Screws indicated for fractures,<br>osteotomies, and non-unions of the radius and other small bones. Additionally, the Metaphyseal Plate<br>is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus,<br>clavicle, and scapula. | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| Type of Use (Select one or both, as applicable)<br>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<br>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<br>See PRA Statement on last page. |
| Indications for Use | |
| 510(k) Number (if known) | K171320 |
| Device Name | ARMAR <sup>TM</sup> / ARTIST <sup>TM</sup> Calcaneal Plate & MBOSS <sup>TM</sup> /FIXION <sup>TM</sup> Screws |
| Indications for Use (Describe) | |
| | ARMAR <sup>TM</sup> / ARTIST <sup>TM</sup> Calcaneal Plate & MBOSS <sup>TM</sup> /FIXION <sup>TM</sup> 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) | |
| | <span> <svg height="12" width="12"> <rect height="12" style="fill:none;stroke:#000000;stroke-width:1" width="12"></rect> <line style="stroke:#000000;stroke-width:1" x1="0" x2="12" y1="0" y2="12"></line> <line style="stroke:#000000;stroke-width:1" x1="12" x2="0" y1="0" y2="12"></line> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <svg height="12" width="12"> <rect height="12" style="fill:none;stroke:#000000;stroke-width:1" width="12"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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,<br>Survey No. 135/2/B & 174/2,<br>Muktanand Marg, Chala, Vapi-396191<br>Gujarat, India |
| Submitter's Telephone | 352-377-1140 |
| Submitter Contact | Umesh Sharma<br>umesh.sharma@merillife.com |
| Contact Person | Meredith May<br>719-337-7579<br>VP, Empirical Consulting |
| Date Summary was<br>Prepared | 24th July 2017 |
| Trade or Proprietary Name | ARMARTM / ARTIST™ Small Fragment and<br>Calcaneal Plates & MBOSS™ / FIXIONT™ Screws<br>ARMARTM / ARTISTM Humerus and Olecranon<br>Plates & MBOSSTM/FIXIONT™ Screws<br>ARMARTM / ARTISTM Tibia and Buttress Plates &<br>MBOSSTM/FIXIONTM Screws<br>ARMARTM / ARTISTM 2.4mm Plates &<br>MBOSSTM/FIXIONT™ Screws<br>ARMARTM / ARTISTM Clavical Hook Plate &<br>MBOSSTM/FIXIONT™ Screws<br>ARMARTM / ARTIST™ Metaphyseal Plate &<br>MBOSSTM/FIXIONTM Screws<br>ARMARTM / ARTISTM Calcaneal Plate &<br>MBOSSTM/FIXIONTM Screws |
| Common or Usual Name | Plate, Fixation, Bone<br>Screw, Fixation, Bone |
| Classification | Class II per 21 CFR §888.3030<br>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.
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### 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.
- 4. 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.
- 5. 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.
- 6. 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.
- 7. 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<br>Name | Manufacturer | Predicate<br>Type |
|------------------------------|---------------------------------------|--------------|-------------------|
| K143331, K083654 | Bone Plates | Zimmer | Primary |
| K121672, K120717,<br>K082625 | Plate System | Synthes | Additional |
| K121601, K120854 | Ankle Trauma System | Synthes | Additional |
| K110125, K102694,<br>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<br>System | Synthes | Additional |
| K071264, K102694,<br>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.
