GPC Intraheal Intramedullary Nailing System

K203811 · Gpc Medical Limited · HSB · Feb 10, 2022 · Orthopedic

Device Facts

• Record ID: K203811
• Device Name: GPC Intraheal Intramedullary Nailing System
• Applicant: Gpc Medical Limited
• Product Code: HSB · Orthopedic
• Decision Date: Feb 10, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

GPC Intraheal Intramedullary Nailing System are provided non-sterile. GPC Intraheal Intramedullary Nailing System are indicated for treating fractures of various bones as given below: Multi Angle Femoral Nail: The indications for Use of Multi Angle Femoral Nails are as given below: - To Stabilize Femoral shaft fractures, Subtrochanteric Fractures, Ipsilateral Neck and Shaft Fracturers, Impending Pathologic Fractures, Nonunions and Malunions. Proximal Hip Stabilizing Nail 3: The indications for Use of Proximal Hip Stabilizing Nail 3 are as given below: Short Nail Indications: - Fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion . and tumor resections . Long Nail Indications: - . Indications may include fractures resulting from trauma, nonunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures. Elastic Nails: The Elastic Nail is indicated for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in paediatric or small statured patients. In paediation, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate. K-Wires: K-wires are indicated to perform as fixation and stabilization unit of bone fractures or as guide at insertion of implants into the skeletal system All implants are for single use only.

Device Story

Intramedullary nailing system for orthopedic fracture fixation; includes femoral nails, proximal hip stabilizing nails, elastic nails, K-wires, locking bolts, and cephalic screws. Implants inserted into medullary canal to stabilize bone segments; provide mechanical support during healing. Used in clinical/surgical settings by orthopedic surgeons. Output is physical stabilization of bone fractures. Benefits include restoration of skeletal alignment and support for bone union. Supplied non-sterile; requires sterilization before use.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing including static four-point bend, bending fatigue, static torsional testing, compression bending, driving torque, and pull-out tests per ASTM standards.

Technological Characteristics

Materials: Stainless Steel (ASTM F138) and Titanium (ASTM F136). Components: Intramedullary nails, locking bolts, end caps, cephalic screws, K-wires. Mechanical fixation via intramedullary insertion. Sterilization: Non-sterile, requires user sterilization. Standards: ASTM F1264, F384, F543, F136, F138.

Indications for Use

Indicated for patients requiring fixation of femoral shaft, subtrochanteric, intertrochanteric, and diaphyseal fractures; nonunions; malunions; pathological fractures; impending pathological fractures; tumor resections; and revision procedures. Applicable to pediatric or small-statured patients for elastic nails. Contraindications not specified.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Synthes Lateral Entry Femoral Nail (K040336)
• GPC Tibial Nail System Ex (K143245)
• Synthes Trochanteric Fixation Nail (TFN) SYSTEM (K011857)
• Gamma 3 Nail System (K043431)
• Synthes Elastic Intramedullary Nail (EIN) System (K971783)
• Synthes Elastic Intramedullary Nail (EIN) End Cap (K053105)
• SMT Schilling Metalltechnik GmbH (K100736)

Submission Summary (Full Text)

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February 10, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters 'FDA' in white. Further to the right, the words 'U.S. FOOD & DRUG' are written in blue, with 'ADMINISTRATION' written in a smaller font size below.

GPC Medical Limited Vikas Narang Director GPC Square, M-Block, DDA LSC, Vikas Puri, New Delhi New Delhi, Delhi 110018 India

Re: K203811

Trade/Device Name: GPC Intraheal Intramedullary Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC, JDS, HTY, JDW Dated: January 12, 2022 Received: January 14, 2022

Dear Vikas Narang:

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 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

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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 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.

For Jiping Chen. M.D., Ph.D., M.P.H. Acting Division Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K203811

Device Name GPC Intraheal Intramedullary Nailing System

Indications for Use (Describe)

GPC Intraheal Intramedullary Nailing System are provided non-sterile. GPC Intraheal Intramedullary Nailing System are indicated for treating fractures of various bones as given below:

Multi Angle Femoral Nail: The indications for Use of Multi Angle Femoral Nails are as given below:

- To Stabilize Femoral shaft fractures, Subtrochanteric Fractures, Ipsilateral Neck and Shaft Fracturers, Impending Pathologic Fractures, Nonunions and Malunions.

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> □ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K203811

Device Name GPC Intraheal Intramedullary Nailing System

### Indications for Use (Describe)

Proximal Hip Stabilizing Nail 3: The indications for Use of Proximal Hip Stabilizing Nail 3 are as given below: Short Nail Indications: -

- Fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion .
- and tumor resections .

Long Nail Indications: -

- . Indications may include fractures resulting from trauma, nonunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.
Type of Use (Select one or both, as applicable)

| <span style="font-family: sans-serif;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|----------------------------------------------------------------------------------------------|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

즈 Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

Page 1 of 1

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K203811

Device Name GPC Intraheal Intramedullary Nailing System

Indications for Use (Describe)

Elastic Nails:

The Elastic Nail is indicated for fixation of diaphyseal fractures of the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures and lower extremity fractures in paediatic or small statured patients. In paediatric application, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate. K-Wires:

K-wires are indicated to perform as fixation and stabilization unit of bone fractures or as guide at insertion of implants into the skeletal system

All implants are for single use only.

| 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) |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

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## C Medical Ltd

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: | GPC Medical Limited. |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Office :GPC Square, M-Block, DDA, LSC, VikasPuri New Delhi,<br>110018 INDIA.<br>Factory : Plot C-3, Sec B-1, UPSIDC, Trans Delhi Signature City,<br>Loni, Ghaziabad, UP 201102 |
| Contact Person Name: | Mr. Vikas Narang |
| Title: | Director |
| Phone Number: | [phone] |
| Dated: | 16-12-2020 |

This is a bundled submission.

Throughout the submission there is a mention of GPC Intraheal Intramedullary Nailing 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:

- . GPC Intraheal Intramedullary Nailing System.
Common or Usual Name:

- Orthopaedic Bone Nail ●
- . Orthopaedic Bone Screw
- Orthopaedic Bone Wire

Classification Name:

- NAIL,FIXATION,BONE
- . SCREWS,FIXATION, BONE
- WIRE, FIXATION, BONE .

Product Code: HSB, HWC, JDS, HTY, JDW

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# C Medical Ltd

Device Class: Il

Review Pane: Orthopaedic

Regulation Number: 21CFR888.3020, 21CFR888.3030 and 21CFR888.3040

### Device Details:

GPC Intraheal Intramedullary Nailing System are manufactured in various shapes and sizes. The intramedullary nails are fixed with corresponding sizes of locking bolts and end caps. GPC Intraheal Intramedullary Nailing System are manufactured using stainless steel or titanium materials for surgical implant applications.

The different sizes and model numbers of GPC Intraheal Intramedullary Nailing System are based on the site of application such as fixation or reconstruction of the bones. These intramedullary nails are available in different diameters and lengths to suit the patient anatomy and size of the bones.

GPC Intraheal Intramedullary Nailing System are typically divided into following three categories:

- 1. Femoral Nails and corresponding locking bolts and end cap for fixation
- 2. Elastic Nails and corresponding end caps for fixation
- 3. K wire for fixation

The specific names of the GPC Intraheal Intramedullary Nails are as given below:

Multi Angle Femoral Nail Proximal Hip Stabilizing Nail 3 (Also called as PHN3) Elastic Nail K.Wire

### 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 |
|--------|------------------------------------|---------------------------------------------------------------------------------------------------|
| 01. | Multi Angle Femoral Nail | Synthes Lateral Entry Femoral Nail (K040336) |
| | Locking Bolts 6.5mm (Self Tapping) | Synthes Lateral Entry Femoral Nail (K040336) (Synthes LFN) |
| | Locking Bolt 4.9mm, Self Tapping | GPC Tibial Nail System Ex (K143245) and Synthes Trochanteric Fixation Nail (TFN) SYSTEM (K011857) |

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# C Medical Ltd

| 02. | Proximal Hip Stabilizing Nail 3 (Short and Long) | Gamma 3 Nail System (K043431) |
|-----|----------------------------------------------------|---------------------------------------------------------------|
| | Cephalic Screw for Proximal Hip Stabilizing Nail 3 | Gamma 3 Nail System (K043431) |
| | Locking Bolt 5.0mm | Gamma 3 Nail System (K043431) |
| 03. | Elastic Nail Titanium | Synthes Elastic Intramedullary Nail<br>(EIN) System (K971783) |
| | End Cap of Elastic Nail Titanium | Synthes Elastic Intramedullary Nail<br>(EIN) End Cap K053105 |
| 04. | K. Wire | SMT Schilling Metalltechnik GmbH<br>(K100736) |

NOTE: The end cap of each type of intramedullary nail is also part of the corresponding intramedullary nail and no separate predicate device is applicable for the end caps.

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

### Device Description of GPC Intraheal Intramedullary Nailing System:

There are following types of Bone Nails used with Locking Screws and Bolt and Wires. The Bone Nails are generally designed on the basis of the bones.

| S. No. | Type | Variants | Angles | Diameters | Lengths | Material of<br>Construction |
|--------|------------------------------------------|----------------------------------------------|------------------------------------------|----------------------|-------------------|---------------------------------|
| 1. | Multi Angle<br>Femoral<br>Nail | With Left<br>and Right<br>Versions | -- | 9mm to<br>12mm | 300mm to<br>460mm | Stainless Steel<br>and Titanium |
| 2. | Proximal<br>Hip<br>Stabilizing<br>Nail 3 | Short | 120 degree,<br>125 degree,<br>130 degree | 10mm, 11mm<br>& 12mm | 180mm to<br>220mm | Stainless Steel<br>and Titanium |
| | | Long( with<br>Left and<br>Right<br>Versions) | 120 degree,<br>125 degree,<br>130 degree | 10mm, 11mm<br>& 12mm | 300mm to<br>480mm | Stainless Steel<br>and Titanium |
| 3. | Elastic Nail<br>Titanium | -- | -- | 2.0mm to<br>4.0mm | 440mm | Titanium |

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### PC Medical Ltd

| 4. | K. Wire<br>Diameter 1.0mm to 4.5mm with length: 100 to 300mm | With Partial Thread, Single Side Trocar, Both Side Trocar | -- | 1.0-4.5mm | 100mm to 300mm | Stainless Steel and Titanium |
|----|--------------------------------------------------------------|-----------------------------------------------------------|----|-----------|----------------------------------------------------------------------------------------------------|------------------------------|
| 5. | Locking Bolts 4.9 mm, self-tapping | -- | -- | 4.9mm | 26-60mm(<br>2mm<br>increment),<br>(64-80mm) 4<br>mm<br>increment<br>(80-100mm)<br>5mm<br>increment | Stainless Steel and Titanium |
| 6. | Self Tapping Locking Bolts 6.5mm | -- | -- | 6.5mm | 60mm to 130mm in 5 mm increments | Stainless Steel and Titanium |
| 7. | Locking Bolts 5.0 mm, self-tapping | -- | -- | 5.0mm | 26mm to 60mm with 2mm increment and 60 to 120mm with 5 mm increment | Stainless Steel and Titanium |
| 8. | Cephalic Screw | -- | -- | 10.5mm | 70mm-130mm with 5mm increments | Stainless Steel and Titanium |

These implants are supplied non-sterile, the products have to be sterilized prior to use.

A5).A statement of the intended use of the device

### Indications for Use:

GPC Intraheal Intramedullary Nailing System are provided non-sterile.

GPC Intraheal Intramedullary Nailing System are indicated for treating fractures of various bones as given

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# edical Lt

below:

### Multi Angle Femoral Nail: The indications for Use of Multi Angle Femoral Nails are as given below:

-To Stabilize Femoral shaft fractures, Subtrochanteric Fractures, Ipsilateral Neck and Shaft Fracturers,

Impending Pathologic Fractures, Nonunions and Malunions.

### Proximal Hip Stabilizing Nail 3: The indications for Use of Proximal Hip Stabilizing Nail 3 are as given below:

Short Nail Indications: -

•Fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections

- Long Nail Indications:-
•Indications may include fractures resulting from trauma, nonunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.

### Elastic Nails:

The Elastic Nail is indicated for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in paediatric or small statured patients. In paediation, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.

### K-Wires:

K-wires are indicated to perform as fixation and stabilization unit of bone fractures or as guide at insertion of implants into the skeletal system

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 GPC Intraheal Intramedullary Nailing System and predicate devices has been performed which has resulted in demonstration of similarities in dimensional and performance criteria.

Following is the summary of parameters in which the comparison has been verified:

| S. No. | Characteristics | Predicate Device Versus New (GPC Intraheal<br>Intramedullary Nailing System) | Remarks on<br>Equivalence |
|--------|------------------------------|------------------------------------------------------------------------------|---------------------------|
| 01 | Regulatory<br>Classification | Same Classification and<br>Regulation Number | Equivalent |
| 02 | Indications for use | Similar intended use in New Device<br>and Predicate device | Equivalent |

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| 03 | Material | Both the predicate and subject<br>devices use material meant for<br>surgical implant application | Equivalent |
|----|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 04 | Performance<br>Standards | Same performance standards used<br>in both New Device as well as<br>predicate device | Equivalent |
| 05 | Sterilization | Same method of sterilization used<br>in both New Device as well as<br>Predicate device | Equivalent |
| 06 | Dimensional<br>Verification | Similar dimensions found in both<br>New<br>Device as well as Predicate device<br>The minor differences that exist, do<br>not raise any safety concerns. | Equivalent |

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. ASTMF136: Standard specification for wrought Titanium-6 VanadiumELI (Extra low interstitial) Alloy for surgical implant applications.

2. Stainless Steel 316L and Stainless Steel 316LVM

The purchased material are in compliance to these standards.

B: Performance Standards:

The device performance of GPC Intramedullary Nailing System has been demonstrated against following applicable standards

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# edical Lt

### For Intramedullary Nails:

- The testing performed As per ASTMF1264 and ASTM F 384 ●
Static Four Point Bend Test: Conforms

Bending Fatique Properties: Conforms

Static Torsional Testing: Conforms

Compression Bending: Conforms

### For Bone Screws:

- The Testing Performed As per ASTMF 543: . Torsional Properties: Conforms, Driving Torque :Conforms, Pull-out Test: Conforms
### For Bone Wires:

Tensile Testing as per ASTM F 136 and ASTM F 138: Conforms

b2). Discussion on the clinical evaluation referenced and relied up on:

GPC Intraheal Intramedullary Nailing System are of similar design and pattern as well as similar intended use as that of predicate devices which are in market already and in clinical use. Therefore Clinical information was not necessary to demonstrate substantial equivalence.

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# GPC Medical Ltd

### CONCLUSION:

General, Safety and Performance conclusion:

From the available data available we can justify that the GPC Intraheal Intramedullary Nailing System are as safe, as effective and perform as same indications for use as that of already marketed predicate devices identified in a 3.of 510(k) summary.

Hence these devices can be considered safe and effective for their intended use.