EBA One Nailing System
Device Facts
| Record ID | K183666 |
|---|---|
| Device Name | EBA One Nailing System |
| Applicant | Citieffe S.R.L. |
| Product Code | HSB · Orthopedic |
| Decision Date | Nov 14, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3020 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
EBA One Nailing System standard trochanteric nail is indicated for the treatment of stable intertrochanteric fractures, pertrochanteric fractures, non-unions, mal-unions. EBA One Nailing System long trochanteric nail is indicated for the treatment of pertrochanteric fractures with extension of the fracture line to the diaphysis,pertrochanteric fractures associated with diaphyseal fractures (bifocal fractures), pathological fractures, non-unions, mal-unions.
Device Story
The EBA One Nailing System is an intramedullary fixation device used by orthopedic surgeons in clinical settings to stabilize femoral fractures. The system consists of standard and long trochanteric nails designed to provide internal fixation for various fracture types, including intertrochanteric, pertrochanteric, and diaphyseal fractures. The device is implanted surgically to provide mechanical support to the bone, facilitating healing and alignment. It serves as a structural implant to restore skeletal integrity in patients suffering from traumatic or pathological fractures, non-unions, or mal-unions.
Clinical Evidence
No clinical data provided; substantial equivalence is based on bench testing and design characteristics.
Technological Characteristics
Intramedullary fixation rod system. Materials and specifications are consistent with standard orthopedic implant requirements for Class II devices under 21 CFR 888.3020.
Indications for Use
Indicated for patients with stable intertrochanteric, pertrochanteric, diaphyseal, or pathological femoral fractures, including non-unions and mal-unions.
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.
Related Devices
- K050118 — EBI TROCHANTERIC NAIL SYSTEM · Ebi, L.P. · Feb 16, 2005
- K131005 — EBA2 FEMORAL NAILING SYSTEM · Citieffe S.R.L. · Jun 25, 2013
- K221084 — Dyna Locking Trochanteric Nail · Innosys · Mar 3, 2023
- K032244 — GAMMA 3 NAIL SYSTEM · Howmedica Osteonics Corp. · Aug 8, 2003
- K172830 — Double Medical Femoral Nail System · Double Medical Technology, Inc. · Aug 24, 2018
Submission Summary (Full Text)
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November 14, 2019
CITIEFFE S.r.l. Stefano Pullega Quality and Regulatory Manager Via Armaroli, 21 CALDERARA di RENO, 40012 ITALY
Re: K183666
Trade/Device Name: EBA One Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: October 14, 2019 Received: October 17, 2019
Dear Stefano Pullega:
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Ting Song Acting Assistant 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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## Indications for Use
510(k) Number (if known) K183666
Device Name EBA One Nailing System
## Indications for Use (Describe)
EBA One Nailing System standard trochanteric nail is indicated for the treatment of stable intertrochanteric fractures, pertrochanteric fractures, non-unions, mal-unions.
EBA One Nailing System long trochanteric nail is indicated for the treatment of pertrochanteric fractures with extension of the fracture line to the diaphysis,pertrochanteric fractures associated with diaphyseal fractures (bifocal fractures), pathological fractures, non-unions, mal-unions.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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