CalcaNail Orthopedic Nail

K150463 · Fournitures Hospitalieres Industrie · HSB · May 22, 2015 · Orthopedic

Device Facts

• Record ID: K150463
• Device Name: CalcaNail Orthopedic Nail
• Applicant: Fournitures Hospitalieres Industrie
• Product Code: HSB · Orthopedic
• Decision Date: May 22, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CalcaNail Orthopedic Nail is intended for fracture fixation in the treatment of patients with displaced articular fractures of the calcaneus.

Device Story

CalcaNail Orthopedic Nail is an intramedullary fixation device for treating displaced articular fractures of the calcaneus. System comprises a 10mm titanium nail (45-55mm lengths) and 5mm cannulated screws (24-80mm lengths). Used by orthopedic surgeons in clinical settings for internal fracture fixation. Device provides mechanical stability to bone fragments to facilitate healing. Output is physical stabilization of the calcaneus. Benefits include improved fracture rigidity compared to traditional cannulated screws and locking plates, as demonstrated by biomechanical testing.

Clinical Evidence

Bench testing only. Biomechanical study using 14 human calcaneal and talar bones compared CalcaNail to Synthes locking plate (K991407); results showed improved primary stability with CalcaNail. Engineering simulation compared moments of inertia against FHI cannulated screws (K070617), demonstrating greater rigidity for the CalcaNail.

Technological Characteristics

Titanium intramedullary nail (10mm diameter, 45-55mm lengths) and cannulated screws (5mm diameter, 24-80mm lengths). Mechanical fixation device. No energy source or software components.

Indications for Use

Indicated for patients with displaced articular fractures of the calcaneus requiring fracture fixation.

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 calcaneal locking plate (K991407)
• FHI cannulated screws (K070617)
• NewDeal Panta Nail (K091788)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 22, 2015

Fournitures Hospitalieres Industrie Ms. Patricia Donnard Regulatory Affairs Manager 6 rue Nobel- ZI de Kernevez 29000 Quimper France

Re: K150463

Trade/Device Name: CalcaNail Orthopedic Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: February 11, 2015 Received: February 23, 2015

Dear Ms. Donnard:

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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Lori A. Wiggins -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K150463

Device Name CalcaNail Orthopedic Nail

Indications for Use (Describe)

The CalcaNail Orthopedic Nail is intended for fracture fixation in the treatment of patients with displaced articular fractures of the calcaneus.

| 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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### 510(k) Summary CalcaNail Orthopedic Nail K150463

May 20, 2015

#### 1. Submitter

Fournitures Hospitalieres Industrie (FHI) ZI de Kernevez – 6 rue Nobel 29000 QUIMPER – FranceFH Orthopedics Establishment Registration # 3003898228 Owner/Operator # 9025586

Contacts: Patricia Donnard Regulatory Affairs Manager Email: [e-mail]

#### Or

Naoual RAHIMI Regulatory Affairs Representative Email: [e-mail]

Tel number: +33.2.98.55.68.95 Fax: [phone]

#### 2. Name of Device

Proprietary Name: CalcaNail Orthopedic Nail

Common Name: Orrthopedic Nail

Device Classification: Intramedullary Fixation Rod

Product Code: 87 HSB (Rod, Fixation, Intramedullary and Accessories)

These devices have been placed in Class II as per 21 CFR Regulation Number 888.3020 and assigned the Product Code 87 HSB.

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## 3. Predicate Devices

The components of the CalcaNail Orthopedic Nail are substantially equivalent to the following legally marketed devices:

- Synthes calcaneal locking plate K991407 O
- FHI cannulated screws K070617 O
- NewDeal Panta Nail K091788 O

This statement is based on the similarity of the subject device to the predicate devices in one or more of intended use, materials, design and principles of operation.

### 4. Device Description

The CalcaNail is orthopaedic nail for the repair of articular fractures of the calcaneus. The device consists of an orthopedic titanium 10 mm nail available in 3 lengths (45 mm, 50 mm and 55 mm) for fracture repair. The system also includes a series of 5 mm cannulated screws for fixation available in 17 lengths (24 mm - 80 mm)

#### 5. Intended Use

The CalcaNail Orthopedic Nail is intended for fracture fixation in the treatment of patients with displaced articular fractures of the calcaneus.

#### 6. Comparison to Predicate Devices

The CalcaNail System has been carefully compared to legally marketed devices with respect to intended use and safety and effectiveness. The Synthes calcaneal locking plate K991407, FHI cannulated screws K070617, NewDeal Panta Nail K091788 are all indicated for use in the foot and ankle including the calcaneous. All devices are manufactured from titanium and/or stainless steel and are available with delivery instruments for proper use.

Seven pairs of (total of 14) enzymatically corroded human calcaneal and talar bones were fixed either by the CalcaNail Orthopedic Screw or Synthes locking plate (K991407) for biomechanical testing. The results of this published testing showed that the primary stability at the chosen experimental set-up of a standardized calcaneal fracture was better with the CalcaNail than with the standard Synthes calcaneal locking plate.

Engineering simulation was used to compare the moments of inertia of the smallest crosssections of the CalcaNail nail comparing this to the currently marketed FHI cannulated screws (K070617). The analysis performed demonstrated the CalcaNail provided much greater rigidity than the cannulated screws used routinely in rear foot deformity surgery.

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## 7. Summary of Substantial Equivalence

Based on the descriptive information and analysis provided FH Industrie has determined that the CalcaNail Calcaneal Nail is substantially equivalent to the predicate devices presented. The bench testing and device description confirms that the subject CalcaNail demonstrate no new issues of safety or effectiveness in treating calcaneal fractures.