Pitkar Locked Plating System

K192619 · S.H.Pitkar Orthotools Pvt. , Ltd. · HRS · Feb 27, 2020 · Orthopedic

Device Facts

• Record ID: K192619
• Device Name: Pitkar Locked Plating System
• Applicant: S.H.Pitkar Orthotools Pvt. , Ltd.
• Product Code: HRS · Orthopedic
• Decision Date: Feb 27, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Pitkar Locked Plating System is indicated for fixation of fractures and non-unions of various bones including the humerus, radius, ulna, femur, tibia, fibula and clavicle, including in osteopenic bone.

Device Story

System consists of metallic bone plates, screws, and surgical instruments; used for internal fixation of fractures, osteotomies, and non-unions in long bones and clavicle. Implants are manufactured from titanium alloy; instruments from stainless steel. Provided non-sterile; requires user-performed steam sterilization. Used by orthopedic surgeons in clinical/OR settings to stabilize bone segments; promotes healing via rigid fixation. Output is physical stabilization of bone; clinical decision-making based on surgeon assessment of fracture type and patient anatomy.

Clinical Evidence

Bench testing only. Performance demonstrated via mechanical testing per ASTM F382 (static/dynamic four-point bend for plates), ASTM F384 (static/dynamic four-point bend for plates), and ASTM F543 (torsional properties, driving torque, pull-out test for screws). No clinical data provided.

Technological Characteristics

Plates/screws: Titanium Alloy (ASTM F136). Instruments: Stainless Steel (ASTM F899). Mechanical fixation via locking plate/screw interface. Non-sterile; steam sterilization required. Standalone mechanical system.

Indications for Use

Indicated for fixation of fractures, osteotomies, and non-unions of the humerus, radius, ulna, femur, tibia, fibula, and clavicle, including 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

• CARE BRAND Locking Bone Plate and Screws Osteosynthesis Plating System (K153374)
• SYNTHES LCP Distal Tibia Plates (K013248)
• SYNTHES LCP Proximal Tibia Plate (K030597)
• SYNTHES LCP Distal Femur Plates (K062564)
• SYNTHES LCP Distal Humerus Plates (K033995)
• SYNTHES LCP Proximal Humerus Plates (K011815)
• SYNTHES Locking Distal Radius Plating System (K012114)
• SYNTHES LCP Clavicle Plate System (K073186)

Submission Summary (Full Text)

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February 27, 2020

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 & 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.

S H Pitkar Orthotools Pvt Ltd. Vivek Mangalwedhekar Head of Firm Plot No. EL 32, J Block, MIDC Bhosari Pune, 411026 India

Re: K192619

Trade/Device Name: Pitkar Locked 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: September 15, 2019 Received: September 23, 2019

Dear Vivek Mangalwedhekar:

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.

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

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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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] 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)

K192619

Device Name Pitkar Locked Plating System

Indications for Use (Describe)

Pitkar Locked Plating System is indicated for fixation of fractures and non-unions of various bones including the humerus, radius, ulna, femur, tibia, fibula and clavicle, including in osteopenic bone.

| Type of Use ( <i>Select one or both, as applicable</i> ) |
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| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
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### 510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Pitkar Locked Plating System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

| 1. Submitter: | S H Pitkar Orthotools Pvt Ltd.<br>Plot No. EL 32, J Block, MIDC Bhosari<br>Pune<br>Maharashtra 411026<br>India |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Vivek Mangalwedhekar<br>Head of Firm<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | 27-Feb-20 |
| 2. Device Name: | Pitkar Locked Plating System |
| Common or Usual Name: | Orthopedic Bone Plate<br>Orthopedic Bone Screw |
| Classification Name: | Plates, Fixation, Bone<br>Screws, Fixation, Bone |
| Product Code: | HRS- Single/multiple component metallic bone<br>fixation appliances and accessories (21 CFR<br>888.3030)<br>HWC -Smooth or threaded metallic bone<br>fixationfastener (21 CFR 888.3040) |
| Regulatory Class: | ll |
| 3. Primary Predicate Device(s): | CARE BRAND Locking Bone Plate and Screws<br>Osteosynthesis Plating System - K153374 |
| Other Predicate Devices : | SYNTHES LCP Distal Tibia Plates - K013248<br>SYNTHES LCP Proximal Tibia Plate - K030597<br>SYNTHES LCP Distal Femur Plates - K062564<br>SYNTHES LCP Distal Humerus Plates - K033995<br>SYNTHES LCP Proximal Humerus Plates -<br>K011815<br>SYNTHES Locking Distal Radius Plating System-<br>K012114<br>SYNTHES LCP Clavicle Plate System - K073186 |
| 4. Device Description: | The purpose of this submission is to request<br>clearance for the new Pitkar Locked Plating<br>System. The Pitkar Locked Plating System<br>implants are designed to address fractures of the<br>humerus, radius, ulna, femur, tibia, fibula, and<br>clavicle. The system is comprised of plates, screws<br>and instruments to facilitate the installation of the<br>implants. The plates and screws are manufactured<br>from Titanium Alloy per ASTM F136. Implants and<br>instruments will be provided in non-sterile<br>configuration and will require steam sterilization<br>prior to use. |
| 5. Indications for Use: | The Pitkar Locked Plating System is indicated for<br>fixation of fractures osteotomies and non-unions of<br>various bones including the humerus, radius, ulna femur, tibia, fibula, and clavicle, including<br>osteopenic bone. |

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- 6. Summary of Technological Characteristics and comparison to predicate device
The rationale for substantial equivalence is based on consideration of the following characteristics:

Design Features: The design features for the Pitkar Locked Plating System is similar to the Primary predicate system device- CARE BRAND Locking Bone Plate and Screws Osteosynthesis Plating System - K153374

Materials & Chemical Compostion:The Pitkar Locked Plating System plates and screws are manufactured from Titanium Alloy (per ASTM F136). Implant grade titanium alloys are commonly used materials in orthopedic implants & instruments are manufactured from Standard Specification For Wrought Stainless Steels For Surgical Instruments (ASTM F899 -2012) similar to the Primary predicate system device- CARE BRAND Locking Bone Plate and Screws Osteosynthesis Plating System - K153374

Sterilization: The implants and instruments are offered to the user in the non-sterile configuration. The non-sterile implants and instruments will be required to be steam sterilized by the user prior to use. The non- sterile packaging configuration is similar to the Primary predicate devices - CARE BRAND Locking Bone Plate and Screws Osteosynthesis Plating System - K153374

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### 7. Summary of Performance Data (Nonclinical and/or Clinical)

### Non-Clinical Tests:

The device performance of Pitkar Locked Plating System has been demonstrated against following applicable standards

- ASTM F 382 ●
- ASTM F 384 ●
- ASTM F 543 .

#### For Bone Plates as per ASTM F 382 & ASTM F 384

- Static Four Point Bend Test ●
- . Dynamic Four Point Bend Test

## For Bone Screws as per ASTM F 543

- Torsional Properties ●
- . Driving Torque
- Pull-Out test ●

### Biocompatibility:

Pitkar Locked Plating System devices are comprised of the same material and have the same manufacturing, body contact, and sterilization properties as other commercially available devices and materials with a long history of clinical use in orthopedic implants. Therefore, the Pitkar Locked Plating System devices meets the ISO 10993-1 standard requirements for biocompatibility and no further characterization testing is required.

8. Conclusion: From the data available, we can justify that the Pitkar Locked Plating System is safe as effective and perform as same indications for use as that of already marketed predicate devices identified in point 3 of 510(k) summary i.e Primary predicate devices CARE BRAND Locking Bone Plate and Screws Osteosynthesis Plating System - K153374

Hence Pitkar Locked Plating System can be considered safe and effective for inteded use.