ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )
Device Facts
| Record ID | K112982 |
|---|---|
| Device Name | ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL ) |
| Applicant | Small Bone Innovations, Inc. |
| Product Code | HSB · Orthopedic |
| Decision Date | Apr 2, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3020 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The SBi Anatomic Ankle Arthrodesis Interlocking Nail System intended for tibiotalocalcaneal arthrodesis of the ankle following: Post traumatic and degenerative arthritis involving both ankle and subtalar joints, osteoarthritis, Rheumatoid arthritis, Pseudoarthrosis, Severe foot/ankle deformity, or Instability and skeletal defects after tumor resection. These include neuro-osteoarthroplasty (Charcot's foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, and for distal tibia fracture non-unions when used concomitantly with tibiotalocalcaneal pathology.
Device Story
SBi Anatomic Ankle Arthrodesis Interlocking Nail System consists of intramedullary implants, associated instruments, and trays. Implants are inserted into the medullary canal of long bones to provide fixation for tibiotalocalcaneal arthrodesis. Used by orthopedic surgeons in clinical/surgical settings. System provides mechanical stabilization of the ankle and subtalar joints to facilitate fusion. Benefits include correction of deformity, stabilization of skeletal defects, and management of complex arthritic or post-traumatic conditions. Implants are single-use; offered sterile or non-sterile.
Clinical Evidence
No clinical data. Evidence provided via bench testing: fatigue testing, cadaver implantation evaluations, finite element analysis, and engineering/dimensional analysis.
Technological Characteristics
Intramedullary fixation rod. Implants made of TiAl6V4 titanium (ASTM F136). Instruments/trays made of Aluminum, stainless steel, PEEK, POM, and composite materials. Single-use. Sterile or non-sterile.
Indications for Use
Indicated for patients requiring tibiotalocalcaneal arthrodesis due to post-traumatic/degenerative arthritis (ankle/subtalar), rheumatoid arthritis, osteoarthritis, pseudoarthrosis, severe foot/ankle deformity, instability/skeletal defects post-tumor resection, Charcot's foot, avascular necrosis of the talus, failed joint replacement, failed ankle fusion, or distal tibia fracture non-unions with concomitant tibiotalocalcaneal pathology.
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
- Stryker T2 Ankle Arthrodesis Nail (K051590)
- Synthes Titanium Cannulated Hindfoot Arthrodesis Nail Expert System (K051678)
Related Devices
- K221031 — Arthrex DualCompression Hindfoot Fusion Nail Implant System · Arthrex, Inc. · Dec 20, 2022
- K102413 — FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL · Vilex, Inc. · Nov 14, 2011
- K192163 — TTC Phantom® Intramedullary Nail System · Paragon 28, Inc. · Jan 31, 2020
- K141571 — ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM · Orthofix Srl · Nov 12, 2014
- K163589 — SIGN IM Nail · Sign Fracture Care International · Jul 20, 2017
Submission Summary (Full Text)
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K112982 1/2
APR - 2 2012
## 510(k) Premarket Notification Summary of Safety and Effectiveness
Submission Information
| Manufacturer: | Small Bone Innovations, Inc.<br>1380 South Pennsylvania Avenue<br>Morrisville, PA 19067<br>Ph: 215-428-1791 Fax: 215-428-1795 |
|---------------|-------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Small Bone Innovations, Inc.<br>Joseph Eble<br>1380 South Pennsylvania Avenue |
Morrisville, PA 19067
Date: October 4, 2011
Proprietary Name: SBi Anatomic Ankle Arthrodesis Interlocking Nail System
Classification name/Identification: Class II, 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
Product Code: HSB
Common/Usual Name and Reference Number: Intramedullary fixation rod - 21 CFR 888.3020
Substantial Equivalence: Documentation is provided which demonstrated the SBi Anatomic Ankle Arthrodesis Interlocking Nail System to be substantially equivalent to other legally marketed devices.
Device Description: The SBi Anatomic Ankle Arthrodesis Interlocking Nail System consists of implants, associated instruments, and trays. The implants are made of implantable grade titanium while the instrument components and trays are made of several materials: Aluminum, stainless steel, PEEK, POM, and composite materials.
Intended Use: The SBi Anatomic Ankle Arthrodesis Interlocking Nail System intended for tibiotalocalcaneal arthrodesis of the ankle following: Post traumatic and degenerative arthritis involving both ankle and subtalar joints, osteoarthritis, Rheumatoid arthritis, Pseudoarthrosis, Severe foot/ankle deformity, or Instability and skeletal defects after tumor resection. These include neuro-osteoarthroplasty (Charcot's foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, and for distal tibia fracture non-unions when used concomitantly with tibiotalocalcaneal pathology.
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The implants are intended for single use only and will be offered sterile and non-sterile.
Materials: The implants are made from implantable grade TiAl6V4 titanium (ASTM F136) while the instrument components and trays are made of several materials: Aluminum, stainless steel, PEEK, POM, and composite materials.
Predicate Devices: The subject devices are equivalent to Stryker T2 Ankle Arthrodesis Nail (K051590) and Synthes Titanium Cannulated Hindfoot Arthrodesis Nail Expert System (K051678).
Non-clinical data: Fatigue testing, cadaver implantation evaluations, literature search and evaluation, finite element analysis, and an engineering/dimensional analysis were performed in order to support substantial equivalence.
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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services (HHS) of the United States. The logo features a stylized caduceus symbol, which is a winged staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Small Bone Innovations, Inc. % Mr. John Minier 1380 South Pennsylvania Ave. Morrisville, PA 19067
APR - 2 2012
Re: K112982
Trade/Device Name: SBi Anatomic Ankle Arthrodesis Interlocking Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: February 2, 2012 Received: February 7, 2012
Dear Mr. Minier:
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 (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
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Page 2 - Mr. John Minier
forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Pen Berts nes ligir
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
## Enclosure
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## 4 Statement of Indications for Use
510(k) Number: 长川2982
Device Name: SBi Anatomic Ankle Athrodesis Interlocking Nail System
Indications For Use:
The SBi Anatomic Ankle Athrodesis Interlocking Nail System is indicated for tibiotalocalcaneal arthrodesis of the ankle following:
- Post traumatic and degenerative arthritis involving both ankle and subtalar joints,
- Rheumatoid arthritis,
- Osteoarthritis,
- Pseudoarthrosis,
- Severe foot/ankle deformity, or
- Instability and skeletal defects after tumor resection.
These include neuro-osteoarthroplasty (Charcot's foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, and for distal tibia fracture non-unions when used concomitantly with tibiotalocalcaneal pathology.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Dision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
112482 510(k) Number
