(88 days)
No
The summary describes a purely mechanical orthopedic implant and fixation system with no mention of AI/ML capabilities or related data/performance metrics.
No
The device is described as an orthopedic nail intended for fracture fixation, which is a structural repair rather than a therapeutic treatment in the conventional sense of treating disease.
No
The CalcaNail Orthopedic Nail is an implantable device used for fracture fixation, not for diagnosing medical conditions.
No
The device description explicitly states it is an orthopedic nail and includes physical components (titanium nail, cannulated screws) for fracture repair, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- CalcaNail Function: The CalcaNail is an orthopedic implant designed for the physical fixation of bone fractures. It is surgically implanted into the body to stabilize a broken bone.
- Lack of Specimen Analysis: The description of the CalcaNail does not involve the analysis of any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the CalcaNail Orthopedic Nail is a surgical implant/orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CalcaNail Orthopedic Nail is intended for fracture fixation in the treatment of patients with displaced articular fractures of the calcaneus.
Product codes
HSB
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calcaneus, foot and ankle
Indicated Patient Age Range
Not Found
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
Bench Testing: 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: 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
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.(b)
Classification. Class II.
0
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
1
(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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: p.donnard@fh-industrie.com
Or
Naoual RAHIMI Regulatory Affairs Representative Email: n.rahimi@fh-industrie.com
Tel number: +33.2.98.55.68.95 Fax: +33.2.98.53.42.13
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.