CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 17, 2016 Ortho Care Mr. Rajeev Chhabra Managing Partner 3/10 Kirti Nagar Industrial Area New Delhi, 110015 INDIA Re: K153374 Trade/Device Name: CARE BRAND Locking Bone Plate and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: April 19, 2016 Received: April 21, 2016 Dear Mr. Chhabra: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing {1}------------------------------------------------ (21 CFR Part 807); labeling (21 CFR Parts 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. ## Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K153374 Device Name CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System Indications for Use (Describe) CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System are provided non-sterile. CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for treating fractures of various bones including the clavis, scapula, long bone ( humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges). CARE Brand of DHS/DCS Plating System is used to provide fixation of fractures to the proximal femur shaft and generally indicated for use in trochanteric, pertrochanteric, intertrochanteric fractures. The system is indicated for use in adult patients only. All implants are for single use only. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### Premarket Notification 510(k) Summary as required by Section 807.92 General Company Information as required by 807:92 (a) (a.1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared Submitter's Name: Ortho Care Address: Office: 3/10 Kirti Nagar Industrial Area, New Delhi-110015 India Factory: Plot Number A-31, Sector A-4, Tronica City, Loni, Ghaziabad, 201102 India | Contact Person Name: | Mr. Rajeev Chhabra | |----------------------|--------------------| | Title: | Managing Partner | | Phone Number: | +91-9810038246 | | Dated: | 05-11-2015 | #### This is a bundled submission. Throughout the submission there is a mention of CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System that represents the range of products covered under this 510(k) submission. {4}------------------------------------------------ ### a.2: The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known #### Proprietary Name: - . CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System ### Common or Usual Name: - Orthopaedic Bone Plates - Orthopaedic Bone Screws #### Classification Name: - PLATES, FIXATION, BONE - · SCREWS, FIXATION, BONE Product Code: HRS, HWC Device Class: ll Review Pane: Orthopaedic Regulation Number: 21 CFR 888.3030 and 21 CFR 888.3040 #### Variants/Types: CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System are further subdivided into following categories | S. No. | Category | Types | |--------|--------------------------------------------------------------------------------------|------------------------------------| | 01 | Dynamic Hip Screw Type /Dynamic<br>Condylar Screw Type DHS and<br>Compression Screws | Non-Locking Version | | 02 | Large Fragment Plates | Locking Version | | 03 | Small Fragment Plates | Locking Version | | 04 | Mini Fragment Plates | Locking Version | | 05 | Bone Screws | Locking and Non-Locking<br>Version | {5}------------------------------------------------ Further Description of CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System Generally there are following types of bone plates used with cortical (cortex) and Locking Screws. These bone plates are generally designed on the basis of the bone contour and anatomy. The Dynamic Hip Screw Plate and Dynamic Condylar Type Plates are used with Dynamic Hip Screw combined with Compression Screw and shaft with cortical (cortex) screws. | S. No. | Type | Subtype | |--------|-----------------------------------------------------------|--------------------------------------------------------------------------------| | 01 | Dynamic Hip Screw Type<br>/Dynamic Condylar Screw<br>Type | Dynamic Hip Screw Plate, Dynamic Condylar Screw Plate | | 02 | Small and Large<br>Fragment | T-Shaped, Hook, Angled Plates. Reconstructions plates | | 03 | Dynamic compression | Small DCP, Narrow DCP, Lengthening Narrow, Broad DCP, Lengthening Broad Plates | | 04 | Mini Fragment | T-Shaped | {6}------------------------------------------------ ### A3) Identification of the Predicate Device: Following are the predicate device 510(k) with which we are declaring substantial equivalence: Following is the range of variants covered with their corresponding predicate devices. | S. No. | Subject Device | Predicate Device | |--------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | Dynamic Hip Screw Plate (with Dynamic Compression<br>Holes) (Long Barrel) | Synthes Limited Contact-Dynamic Hip Screw<br>Implant (LC-DHS)" for K923613 | | | Dynamic Hip Screw Plate (with Dynamic Compression<br>Holes) (Short Barrel) | Synthes Titanium Limited Contact-Dynamic<br>Hip Screw Implant (Ti LC-DHS)" for K953607 | | 2. | Dynamic Condylar Plate with Dynamic Compression<br>Holes (Barrel length 25 mm) | Synthes dynamic condylar screw or d.c.s.<br>K840954 | | 3. | Dynamic Hip Screw, Ø 12.5mm with Compression<br>Screw | Synthes Limited Contact-Dynamic Hip Screw<br>Implant (LC-DHS)" for K923613 | | | | Synthes Titanium Limited Contact-Dynamic<br>Hip Screw Implant (Ti LC-DHS)" for K953607 | | 4. | LCP Curved Narrow Plates | Synthes 3.5 mm and 4.5 mm<br>Curved Narrow and Broad Locking<br>Compression Plates<br>(LCP) (K092609) | | 5. | Narrow Locking Plate For 4.5mm/5.0mm Screws | Synthes 3.5 and 4.5mm Locking<br>Compression Plate System (K082807) | | 6. | Locking Reconstruction Plate 4.5mm | Synthes 4.5 mm LCP Straight<br>Reconstruction Plate (K051986) | | 7. | LCP Curved Broad Plates | Synthes 3.5 mm and 4.5 mm<br>Curved Narrow and Broad Locking<br>Compression Plates<br>(LCP) (K092609) | | 8. | Broad Locking Plate For 4.5mm/5.0mm Screws | Synthes 3.5 and 4.5mm Locking<br>Compression Plate System (K082807) | | 9. | Locking distal femur plate - right<br>Locking distal femur plate - left | Synthes LCP Distal Femur<br>Plates (K062564) | | 10. | Proximal Lateral Tibia Locking Plate Left<br>Proximal Lateral Tibia Locking Plate Right | K030597 Synthes 3.5 Titanium LCP<br>Proximal Tibia Plate (For Titanium)<br>Synthes LCP Proximal Tibia<br>Plate (K011978) (For Stainless Steel) | | 11. | Locking Femoral Proximal Lateral Plates L/R 5 Holes<br>To 13 Holes, Left<br>Locking Femoral Proximal Lateral Plates L/R 5 Holes<br>To 13 Holes, Right | Synthes (USA) LCP Proximal Femur Plate<br>and Screws (K030858) | | 12. | Locking Humeral Distal Dorsal Plates L/R Without<br>Support 2.7/3.5, Left & Right | Synthes 3.5mm LCP Distal<br>Humerus System (K033995) | | 13. | Locking Humeral Distal Dorsal Plates L/R With Lateral<br>Support 2.7/3.5, Left & Right | Synthes 3.5mm LCP Distal<br>Humerus System (K033995) | | 14. | Distal Tibial Locking Plate 2.7/3.5, Left | Synthes Medial Distal Tibia Plate<br>(K001945) | | 15 | Distal Tibial Locking Plate 2.7/3.5, Right | Synthes Medial Distal Tibia Plate<br>(K001945) | | 16. | Locking philos proximal humeral plate - Long<br>Locking philos proximal humeral plate - Short | Synthes (USA) LCP® Proximal Humerus<br>Plates, Long (K041860) | | 17. | Small Locking Plate For Dia 3.5mm Screws | Synthes 3.5 and 4.5mm Locking<br>Compression Plate System with expended<br>indications (K082807) | | 18. | Locking Proximal Humeral Plate - long<br>Locking Proximal Humeral Plate - short | Proximal humerus plate long<br>Synthes K041860 | | 19. | Locking T-Plate Oblique angled For Dia 3.5mm<br>Screws, Left | Synthes Small Fragment Dynamic<br>Compression Locking(DCL) System<br>(K000684) | | 20 | Locking T-Plate Oblique angled For Dia 3.5mm<br>Screws, Right | Synthes Small Fragment Dynamic<br>Compression Locking(DCL) System<br>(K000684) | | 21. | Locking T-Plate Right Angle FOR Dia 3.5mm Screws,<br>3 Hole Head | Synthes Small Fragment Dynamic<br>Compression Locking(DCL)<br>System(K000684) | | 22 | Locking T-Plate Right Angle FOR Dia 3.5mm Screws,<br>4 Hole Head | Synthes Small Fragment Dynamic<br>Compression Locking(DCL)<br>System (K000684) | | 23. | LCP Proximal Tibial Plate 3.5, Left | Synthes 3.5mm Titanium LCP Proximal<br>Tibia Plate (K030597) OR Synthes LCP<br>Proximal Tibia Plates (K011978) | | 24 | LCP Proximal Tibial Plate 3.5, Right | Synthes 3.5mm Titanium LCP Proximal<br>Tibia Plate (K030597) OR Synthes LCP<br>Proximal Tibia Plates (K011978) | | 25. | LCP Clavicle Hook Plate, Left | Synthes Clavicle Hook Plate<br>(K061753) | | 26 | LCP Clavicle Hook Plate, Right | Synthes Clavicle Hook Plate<br>(K061753) | | 27. | Locking Distal Dorsal Radius T-Plates 2.7mm, 3Holes | K012114 (Synthes locking distal radius<br>plating system) | | 28 | Locking Distal Dorsal Radius T-Plates 2.7mm, 4Holes | LCP Radial Head Plating System<br>(K040777) | | 29. | Locking Compression EXTRA-ARTICULAR VOLAR<br>DISTAL RADIUS PLATES 2.4 HEAD 4HOLES, Left<br>and Right with Shaft having 3 Holes, 4 Holes and 5<br>Holes | LCP Radial Head Plating<br>System (K040777) | | 30. | Locking Head Screw, Dia - 2.4mm - Self Tapping | Synthes<br>2.4mm titanium locking screw<br>(K040777) | | 31. | Locking Head Screw, Dia - 2.7mm - Self Tapping | Synthes LCP Modular Foot plate<br>(K050110) | | 32. | Locking Head Screw, Dia - 3.5mm - Self Tapping | Synthes Small Fragment Dynamic<br>Compression Locking (DCL) System<br>(K000684) | | 33. | Locking Head Screw, Dia - 5.0mm - Self Tapping | Synthes Large Fragment Dynamic<br>Compression Locking (DCL) System<br>(K000682) | | 34. | Cortex Screw Ø 3.5mm, Self Tapping | Synthes Cortical Screws K112583 | | 35. | Cortex Screw Ø 4.5mm, Self Tapping | Synthes Cortical Screws (K112583) | {7}------------------------------------------------ {8}------------------------------------------------ a4). A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or promotional material for the device {9}------------------------------------------------ #### Device Description: CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws, compression and dynamic screws. The plates and screws are fabricated from Stainless Steel and Titanium. 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: like, Reconstruction Plates, T- Plates, Anatomical Plates, Clavicle Hook Plates. These all are mainly divided into - DHS/DCS Plates. - Large Fragment Plates - Small Fragment Plates - Mini Fragment Plates The number of the holes varies from 2 to 22. The Locking screw implants are in corresponding diameter ranges from 2.4mm, 2.7mm, 3.5mm, 5.0mm diameters with lengths varying as per the requirements and minimum length: 6 mm to maximum length 90mm. The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 74mm. CARE Brand of DHS/DCS Plating System consist of DHS/DCS Plates, lag Screw, compression screw, and 4.5 Cortex screw (Standard and Self Tapping). The DHS plates are available with barrel length 25mm (short barrel) and 38mm (Standard barrel angels varies from 130° to 150°. The DHS/DCS Screw is available in total length from 50 to 120 mm. thread length 22mm. shaft diameter of 12.5. The thread of DHS/DCS Screw has a buttress type. The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 36mm and outer diameter 3.8 mm. These devices are not indicated for use in spine. These implants are supplied non-sterile, the products have to be sterilized prior to use. {10}------------------------------------------------ #### A5). (5) A statement of the intended use of the device #### Indications for Use: • CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System are provided non-sterile. CARE 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). CARE Brand of DHS/DCS Plating System is used to provide fixation of fractures to the proximal femur shaft and generally indicated for use in trochanteric, intertrochanteric fractures. The system is indicated for use in adult patients only. All implants are for single use only. #### A6). Summary of Technological Characteristics as compared to the predicate devices: #### Substantial equivalence including comparison with predicate devices A comparison between the CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS 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<br>Device (Care Brand) | Remarks | |--------|-----------------------------|-------------------------------------------------------------------------------------|------------| | 01 | Indications for use | Similar intended use in New Device and<br>Predicate device | Equivalent | | 02 | Material | Same material used in New Device and<br>Predicate device | Equivalent | | 03 | Performance<br>Standards | Same performance standards used in both<br>New Device as well as predicate device | Equivalent | | 04 | Sterilization | Same method of sterilization used in both<br>New Device as well as Predicate device | Equivalent | | 05 | Dimensional<br>Verification | Same dimensions found in both New<br>Device as well as Predicate device | Equivalent | #### Following is the summary of parameters in which the comparison has been verified: {11}------------------------------------------------ #### b1). Discussion on the non-clinical testing performed Following are the applicable product standards considered for non-clinical standards - 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 - 1. ASTM F 136: Standard specification for wrought Titanium-6Aluminium-4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications. - 2. ASTM F 138: Standard Specification for Wrought 18 chromium-14Nickel-2.5Molybdenum stainless steel bar and wire for surgical implants. - 3. ASTM 139: Standard Specification for Wrought 18Chromium-14Nickel-F 2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants We have verified the purchased material compliance to these standards and copies of the relevant test results were provided in the submission. #### B: Performance Standards: The device performance of CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System has been demonstrated against following applicable standards - . ASTM F 382, - . ASTM F 384 and - ASTM F 543. #### For Bone Plates: As per ASTM F 382 and ASTM F 384 Static Four Point Bend Test: Conforms, Dynamic Four Point Bend Test: Conforms #### For Bone Screws: As per ASTM F 543 : Torsional Properties: Conforms, Driving Torque : Conforms, Pull-out Test: Conforms {12}------------------------------------------------ #### b2). Discussion on the clinical evaluation referenced and relied upon: CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System are of similar design and pattern as well as similar intended use. Clinical information was not necessary to demonstrate substantial equivalence. #### CONCLUSION: #### General, Safety and Performance conclusion: From the available data available we can justify that the CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System are as safe, as effective and perform as same indications for use as that of already marketed predicate devices identified in a3. of 510(k) summary. Hence these devices can be considered safe and effective for their intended use.