(90 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 features that would suggest the use of these technologies. The performance studies focus on mechanical properties of the implants.
Yes
The device is intended for fixation of fractures, non-unions, malunions, and osteotomies of various bones, which is a therapeutic purpose to aid in the healing and stabilization of skeletal injuries.
No
The device description clearly states its purpose is for "fixation of complex intra- and extra-articular fractures arid osteotomies" and "osteosynthesis," indicating it is for treatment and repair, not diagnosis.
No
The device description clearly states that the system consists of physical components such as plates, screws, and instruments made from Stainless Steel and Titanium alloy. These are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for the fixation of fractures and osteotomies of various bones in the human body. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a system of bone plates and screws made from stainless steel and titanium alloy, designed for osteosynthesis (surgical fixation of bone). This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents, calibrators, or controls
The device is a surgical implant used to stabilize bones, which falls under the category of medical devices, but specifically not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The 2.4mm Secure Locking Variable Angle Distal Radius Plate and Ø2.4 mm Secure Locking Screws, Self-Tapping are intended for fixation of complex intra- and extra-articular fractures arid osteotomies of the distal radius.
The 2.7mm/3.5mm Secure Locking Distal Humerus Medial Plate, 2.7mm/3.5mm Secure Locking Distal Humerus, Dorsolateral Plate, and 2.7mm/3.5mm Secure Locking Distal Humerus Plate, Dorsolateral With Lateral Support are indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, and nonunions of the distal humerus.
The 3.5mm Secure Locking Small Plate, 3.5mm Secure Locking T-Plate, Small with 3 Head Holes, and Ø3.5 mm Secure Locking Screws, Self-Tapping, are indicated for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula.
The 3.5 mm Secure Locking Superior-Anterior Clavicle Plate and 3.5 mm Secure Locking Superior-Anterior Clavice Plate With Lateral Extension is indicated for fixation of fractures, malunions, and ostectornies of the clavice in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.
The 3.5mm Secure Locking Olecranon Plate is indicated for fractures, osteotomies, malunions and non-unions of the olecranon.
The 3.5 mm Secure Locking Philos Proximal Humeral Internal Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.
The 4.5/5.0mm Secure Locking Narrow LC Dynamic Compression Plate is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, and fixation of nonunions or malunions in adult patients.
The 4.5mm/5.0mm Secure Locking Distal Femoral Plate is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures, nonunions and malunions, and osteotomies of the femur.
The 4.5mm/5.0mm Secure Locking Medial Proximal Tibia Plate is intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of nonunions of the medial proximal tibia and tibia shaft.
The 4.5mm/5.0mm Secure Locking L Buttress Plate and 4.5mm/5.0mm Secure Locking T Buttress Plate are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial tibia. Also, for use in fixation of non-unions and malunions.
The 3.5mm/4.5mm/5.0mm Secure Locking Distal Tibia Plates are intended treatment of non-unions, and fractures of the distal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
The Ø3.5mm CORTICAL SCREW and Ø4.5mm CORTICAL SCREW are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The Ø2.7 mm Secure Locking Screws, Self Tapping, and Ø 2.7mm Cortical Screws are intended for fractures and osteotomies of small bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The Ø5.0mm Secure Locking Screws, Self-Tapping are intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions.
The 6.5mm Cancellous Screw, 16mm Thread, 32 Thread, Ø4.0mm CANCELLOUS SCREW, Partial Thread, Full Thread, and Ø4.0mm SMALL CANCELLOUS CANNULATED SCREW, Partial Thread, Full Thread are indicated for use in hindfoot and midfoot fusions, subtalar fusions, calcaneal osteotomies, midfoot reconstruction, and ankle arthrodeses.
The 6.5mm Cancellous Cannulated Screw, 16mm Thread, 32 Thread, and 7.0mm Cancellous Cannulated Screw, 16mm Thread, 32 Thread, Full Thread, are indicated for fracture fixation of large bone fragments, such as tibial plateau fractures, ankle arthrodeses, intercondylar femur fractures; and subtalar arthrodeses.
Product codes
HRS, HWC
Device Description
HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System consists of various shapes and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking selftapping screws, compression and dynamic screws. The subject device system also consists of a variety of general use instruments (Class I), which include drill bits, forceps, plate benders, and drill guides. The plates and screws are manufactured from Stainless Steel and Titanium alloy. The 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, such as:, Reconstruction Plates, T-Plates, Anatomical Plates, Clavicle Plates. These all are mainly divided into: Large Fragment Plates, Small Fragment Plates, Mini Fragment Plates. The locking screw implants are offered in corresponding diameter ranges from 2.4mm, 2.7mm, 3.5mm, 5.0mm diameters with lengths varying from a minimum length of 6 mm to maximum length of 90mm. The non-locking screw implants are offered in 2.7mm, 3.5mm and 4.5mm diameters, with lengths ranqing from 10mm to 80mm. The cancellous screw implants are 4.0mm and 6.5mm in diameter, with lengths ranging from 10 to 120 mm. The cancellous cannulated screw implants are offered in 4.0mm. 6.5mm and 7.0mm diameters and lengths ranging from 16mm to 130 mm. HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are provided non-sterile, the products must be sterilized prior to use. All implants are for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius, distal humerus, clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, femur, foot, ankle, hand, calcaneous
Indicated Patient Age Range
Adults, adolescents (12-18 years), transitional adolescents (18-21 years), children (2-12 years). For certain devices, specific age ranges are provided with the condition that growth plates have fused or will not be crossed by the plate system. For others, only adult patients are specified.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed against applicable product standards: Material Standards (ASTM F136, ASTM F138, ASTM F139) and Performance Standards (ASTM F382, ASTM F384 for bone plates; ASTM F543 for bone screws).
For Bone Plates:
As per ASTM F382 and ASTM F384: Static Four Point Bend Test: Conforms, Dynamic Four Point Bend Test: Conforms
For Bone Screws:
As per ASTMF 543: Torsional Properties: Conforms, Driving Torque: Conforms, Pull-out Test: Conforms
Clinical information was not necessary to demonstrate substantial equivalence.
Key results: The device conforms to the specified performance standards for bone plates and screws.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes 3.5 and 4.5mm Locking Compression Plate System (K082807), Synthes 3.5mm LCP Clavicle Plate System (K111540), Synthes Variable Angle LCP Elbow System (K120070), Synthes Variable Angle Locking Compression Plates Distal Radius System (K071184), Synthes 3.5mm LCP Distal Humerus System (K033995), Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plate (K032269), Synthes (USA) LCP® Proximal Humerus Plates, Long (K041860), Synthes LCP Distal Femur Plates (K062564), Synthes (USA) Medial Distal Tibia Plate (K001945), Synthes LCP Proximal Tibia Plate (K011978), Synthes Cortical Screws (K112583), Synthes (USA) 6.5 mm Cancellous Screws (K061621), Synthes 6.5mm Cannulated Screws (K021932), Synthes 7.0/7.3 cannulated cancellous screws (K962011)
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.
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October 27, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
Hospital Equipment Manufacturing Company Himanshu Sachdeva Director A19/A20, Sector 7 Noida, Uttar Pradesh 201301 India
Re: K222282
Trade/Device Name: HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, HEMC BRAND of DHS 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: July 29, 2022 Received: July 29, 2022
Dear Himanshu Sachdeva:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222282
Device Name
HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
Indications for Use (Describe)
The 2.4mm Secure Locking Variable Angle Distal Radius Plate and Ø2.4 mm Secure Locking Screws, Self-Tapping are intended for fixation of complex intra- and extra-articular fractures arid osteotomies of the distal radius.
The 2.7mm/3.5mm Secure Locking Distal Humerus Medial Plate, 2.7mm/3.5mm Secure Locking Distal Humerus, Dorsolateral Plate, and 2.7mm/3.5mm Secure Locking Distal Humerus Plate, Dorsolateral With Lateral Support are indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, and nonunions of the distal humerus.
The 3.5mm Secure Locking Small Plate, 3.5mm Secure Locking T-Plate, Small with 3 Head Holes, and Ø3.5 mm Secure Locking Screws, Self-Tapping, are indicated for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula.
The 3.5 mm Secure Locking Superior-Anterior Clavicle Plate and 3.5 mm Secure Locking Superior-Anterior Clavice Plate With Lateral Extension is indicated for fixation of fractures, malunions, and ostectornies of the clavice in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.
The 3.5mm Secure Locking Olecranon Plate is indicated for fractures, osteotomies, malunions and non-unions of the olecranon.
The 3.5 mm Secure Locking Philos Proximal Humeral Internal Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.
The 4.5/5.0mm Secure Locking Narrow LC Dynamic Compression Plate is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, and fixation of nonunions or malunions in adult patients.
The 4.5mm/5.0mm Secure Locking Distal Femoral Plate is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures, nonunions and malunions, and osteotomies of the femur.
The 4.5mm/5.0mm Secure Locking Medial Proximal Tibia Plate is intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of nonunions of the medial proximal tibia and tibia shaft.
The 4.5mm/5.0mm Secure Locking L Buttress Plate and 4.5mm/5.0mm Secure Locking T Buttress Plate are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial tibia. Also, for use in fixation of non-unions and malunions.
The 3.5mm/4.5mm/5.0mm Secure Locking Distal Tibia Plates are intended treatment of non-unions, and fractures of the distal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar,
3
combinations of lateral wedge and depression, and fractures with associated shaft fractures.
The Ø3.5mm CORTICAL SCREW and Ø4.5mm CORTICAL SCREW are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The Ø2.7 mm Secure Locking Screws, Self Tapping, and Ø 2.7mm Cortical Screws are intended for fractures and osteotomies of small bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The Ø5.0mm Secure Locking Screws, Self-Tapping are intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions.
The 6.5mm Cancellous Screw, 16mm Thread, 32 Thread, 04.0mm CANCELLOUS SCREW, Partial Thread, Full Thread, and Ø4.0mm SMALL CANCELLOUS CANNULATED SCREW, Partial Thread, Full Thread are indicated for use in hindfoot and midfoot fusions, subtalar fusions, calcaneal osteotomies, midfoot reconstruction, and ankle arthrodeses.
The 6.5mm Cancellous Cannulated Screw, 16mm Thread, 32 Thread, and 7.0mm Cancellous Cannulated Screw, 16mm Thread, 32 Thread, Full Thread, are indicated for fracture fixation of large bone fragments, such as tibial plateau fractures, ankle arthrodeses, intercondylar femur fractures; and subtalar arthrodeses.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K22282 - 510(k) Summary
Pre-market Notification 510(k)Summary as required by Section 807.92
General Company Information as required by 807:92(a)
a(1). The submitter's name, address, telephone number, a contact person, and the date the summary was prepared:
| 510(k) submitter | : | Hospital Equipment Mfg. Co. |
|---|---|---|
| Head office Address | : | D-313, D Block, Sector 63, Noida, Uttar Pradesh- 201301, India |
| Manufacturing Unit | ||
| Address | : | A-19/ A-20, Sector-7, Noida, District Gautam Budha Nagar, UP-201301 |
| Contact person name | : | Mr. Himanshu Sachdeva |
| Title | : | Director |
| Phone number | : | +91 9810053889 |
| Dated | : | October 25, 2022 |
This is a bundled submission.
Throughout the submission there is a mention of HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, that represents the range of products covered under this 510(k) submission.
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: HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
Common or Usual Name:
- Orthopedic Bone Plates ●
- Orthopedic Bone Screws
Classification Name:
- PLATES, FIXATION, BONE
- SCREWS, FIXATION, BONE ●
Product Code: HRS, HWC Device Class: Class II Review Panel: Orthopedic
Regulation Number: 21 CFR 888.3030 – Single/multiple component metallic bone fixation appliances and accessories and 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener
HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are further sub divided into following categories:
| S. No. | Type |
|---|---|
| 01 | Mini Fragment, Small Fragment and Large Fragment |
| 02 | Corresponding Bone Screws - Locking and Non-Locking Version |
Generally, the bone plates are used with cortical (cortex), cancellous, and locking and non-locking screws. These bone plates are generally designed on the basis of the bone contour and anatomy.
5
a(3). Identification of the Predicate Devices:
The following are a list of the 510(k) predicate devices with which we are declaring substantial equivalence:
| No. | Primary Predicate Device |
|---|---|
| 1 | Synthes 3.5 and 4.5mm Locking Compression Plate System (K082807) |
| No. | Other Predicate Devices |
| 2 | Synthes 3.5mm LCP Clavicle Plate System (K111540) |
| 3 | Synthes Variable Angle LCP Elbow System (K120070) |
| 4 | Synthes Variable Angle Locking Compression Plates Distal Radius System (K071184) |
| 5 | Synthes 3.5mm LCP Distal Humerus System (K033995) |
| 6 | Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plate (K032269) |
| 7 | Synthes (USA) LCP® Proximal Humerus Plates, Long (K041860) |
| 8 | Synthes LCP Distal Femur Plates (K062564) |
| 9 | Synthes (USA) Medial Distal Tibia Plate (K001945) |
| 10 | Synthes LCP Proximal Tibia Plate (K011978) |
| 11 | Synthes Cortical Screws (K112583) |
| 12 | Synthes (USA) 6.5 mm Cancellous Screws (K061621) |
| 13 | Synthes 6.5mm Cannulated Screws (K021932) |
| 14 | Synthes 7.0/7.3 cannulated cancellous screws (K962011) |
a(4). A description of the device that is the premarket notification submission, such as might be found in the labeling or promotional material for the device:
Device Description:
HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System consists of various shapes and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking selftapping screws, compression and dynamic screws. The subject device system also consists of a variety of general use instruments (Class I), which include drill bits, forceps, plate benders, and drill guides.
The plates and screws are manufactured from Stainless Steel and Titanium alloy.
The 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, such as:, Reconstruction Plates, T-Plates, Anatomical Plates, Clavicle Plates.
These all are mainly divided into:
- . Large Fragment Plates
- Small Fragment Plates ●
- Mini Fragment Plates .
The locking screw implants are offered in corresponding diameter ranges from 2.4mm, 2.7mm, 3.5mm, 5.0mm diameters with lengths varying from a minimum length of 6 mm to maximum length of 90mm.
The non-locking screw implants are offered in 2.7mm, 3.5mm and 4.5mm diameters, with lengths ranqing from 10mm to 80mm.
The cancellous screw implants are 4.0mm and 6.5mm in diameter, with lengths ranging from 10 to 120 mm. The cancellous cannulated screw implants are offered in 4.0mm. 6.5mm and 7.0mm diameters and lengths ranging from 16mm to 130 mm.
HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are provided non-sterile, the products must be sterilized prior to use. All implants are for single use only.
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a(5). A statement of the intended use of the device.
HEMC 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).
Indications for Use:
The 2.4mm Secure Locking Variable Angle Distal Radius Plate and Ø2.4 mm Secure Locking Screws, Self-Tapping are intended for fixation of complex intra- and extra-articular fractures arid osteotomies of the distal radius.
The 2.7mm/3.5mm Secure Locking Distal Humerus Medial Plate, 2.7mm/3.5mm Secure Locking Distal Humerus. Dorsolateral Plate. and 2.7mm/3.5mm Secure Locking Distal Humerus Plate. Dorsolateral With Lateral Support are indicated for intra-articular fractures of the distal humerus. comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.
The 3.5mm Secure Locking Small Plate, 3.5mm Secure Locking T-Plate, Small with 3 Head Holes, and Ø3.5 mm Secure Locking Screws, Self-Tapping, are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula.
The 3.5 mm Secure Locking Superior-Anterior Clavicle Plate and 3.5 mm Secure Locking Superior-Anterior Clavicle Plate With Lateral Extension is indicated for fixation of fractures, malunions, nonunions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.
The 3.5mm Secure Locking Olecranon Plate is indicated for fractures, osteotomies, malunions and nonunions of the olecranon.
The 3.5 mm Secure Locking Philos Proximal Humeral Internal Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.
The 4.5/5.0mm Secure Locking Narrow LC Dynamic Compression Plate is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, and fixation of nonunions or malunions in adult patients.
The 4.5mm/5.0mm Secure Locking Distal Femoral Plate is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures, nonunions and malunions, and osteotomies of the femur.
The 4.5mm/5.0mm Secure Locking Medial Proximal Tibia Plate is intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of nonunions and malunions of the medial proximal tibia and tibia shaft.
The 4.5mm/5.0mm Secure Locking L Buttress Plate and 4.5mm/5.0mm Secure Locking T Buttress Plate are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. Also, for use in fixation of non-unions and malunions.
The 3.5mm/4.5mm/5.0mm Secure Locking Distal Tibia Plates are intended treatment of non-unions, malunions, and fractures of the distal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
The Ø3.5mm CORTICAL SCREW and Ø4.5mm CORTICAL SCREW are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
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The Ø2.7 mm Secure Locking Screws, Self-Tapping, and Ø 2.7mm Cortical Screws are intended for fractures and osteotomies of small bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The Ø5.0mm Secure Locking Screws, Self-Tapping are intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions.
The 6.5mm Cancellous Screw, 16mm Thread, 32 Thread, Ø4.0mm CANCELLOUS SCREW, Partial Thread, Full Thread, and Ø4.0mm SMALL CANCELLOUS CANNULATED SCREW, Partial Thread, Full Thread are indicated for use in hindfoot fusions, subtalar fusions, calcaneal osteotomies, midfoot reconstruction, and ankle arthrodeses.
The 6.5mm Cancellous Cannulated Screw, 16mm Thread, 32 Thread, Full Thread, and 7.0mm Cancellous Cannulated Screw. 16mm Thread, 32 Thread, are indicated for fracture fixation of large bones and large bone fragments, such as tibial plateau fractures, ankle arthrodeses, intercondylar femur fractures; and subtalar arthrodeses.
a(6). Summary of Technological Characteristics as compared to the predicate devices:
Substantial equivalence including comparison with predicate devices
A comparison between the HEMC 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 (HEMC 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:
b(1). Discussion on the non-clinical testing performed:
Following are the applicable product standards considered for non-clinical standards: A:Material Standards B: Performance Standards
A: Material Standards:
The material standards are the essential part to be complied to first, as it is the basis of manufacturing metallic surgical implants.
We have complied to following material standards:
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- ASTM F136: Standard specification for wrought Titanium-6 Aluminium-4 Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.
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- ASTM F138: Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum
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stainless steel bar and wire for surqical implants.
- ASTM F139: Standard Specification for Wrought 18Chromium-14Nickel-3.
2.5MolvbdenumStainlessSteel 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.
B: Performance Standards:
The device performance of HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System has been demonstrated against the following applicable standards and FDA guidance documents to demonstrate substantial equivalence to the predicate devices:
- . ASTM F382: Standard Specification and Test Method for Metallic Bone Plates ,
- ASTM F384: Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture ● Fixation Devices
- . ASTM F543: Standard Specification and Test Methods for Metallic Medical Bone Screws.
- . FDA quidance document, "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway" (December 2020)
- . FDA guidance document, "Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway " (April 2022)
For Bone Plates:
As per ASTM F382 and ASTM F384: Static Four Point Bend Test: Conforms, Dynamic Four Point Bend Test: Conforms
For Bone Screws:
As per ASTMF 543: Torsional Properties: Conforms, Driving Torque: Conforms, Pull-out Test: Conforms
b(2). Discussion on the clinical evaluation referenced and relied upon:
HEMC 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 data available we can justify that the HEMC 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 Section a(3). of this 510(k) summary.
Hence, these devices can be considered substantially equivalent to the predicate devices.