(31 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of an intramedullary nail system, with no mention of AI or ML capabilities.
No
The device is described as an implantable intramedullary nail system intended for temporary stabilization of bone fractures, not for direct therapeutic treatment beyond stabilization.
No
The device is an orthopedic implant (intramedullary nails and screws) used for temporary stabilization of humeral fractures, not for diagnosing medical conditions.
No
The device description explicitly states that the system includes intramedullary nails and screws, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus." This describes a surgical implant used to treat bone fractures.
- Device Description: The device is described as "intramedullary nails and screws" made of a titanium alloy. This is consistent with a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (like blood, urine, or tissue) to provide information about a person's health.
IVD devices are used in vitro (outside the body) to examine specimens. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Tornier Aequalis Humeral Nail System is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).
Product codes
HSB
Device Description
The Tornier Aequalis Humeral Nail System includes intramedullary nails and screws. The Tornier Aequalis Humeral Nail is a straight, cannulated intramedullary nail with a tapered distal diameter. Nails are provided in right and left configurations with a 9mm diameter and 130mm length. The proximal end of the nail contains screw holes in four axes for proximal locking using 5mm cannulated or non-cannulated screws. The proximal end of the nail also contains a cannulated polyethylene insert with screw holes aligned with those of the nail. This insert is intended to help prevent the proximal screws from backing out. The distal end of the nail incorporates one screw hole for distal locking using 4.5mm screws. The nail and screws are manufactured from anodized Ti-6Al-4V alloy. The purpose of this 510(k) is to add 7mm or 8mm proximal diameter nails in lengths of 130mm, 210mm, 230mm, 250mm, and 270mm lengths to the predicate system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical laboratory assessment/testing was performed to evaluate the device performance per design requirements and risk analysis, including bending calculation comparisons and torque testing. All tests met the pre-established acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/1 description: The image shows the word "TORNIER" in a bold, sans-serif font, followed by a hexagon containing a stylized letter "T". The letter "T" inside the hexagon is also in a bold font and has a unique design. The overall design appears to be a logo or brand mark.
510(k) Summary
| 510(K) Owner's Name: | Tornier Inc. | |
|---|---|---|
| Address: | 10801 Nesbitt Avenue South | |
| Bloomington, Minnesota 55437 | ||
| Phone and Fax Numbers: | Phone: 952.426.7600 | |
| Fax: 952.426.7601 | ||
| Name of Contact Person: | Janell A. Colley | |
| Date Prepared: | December 5, 2013 | DEC 05 2013 |
| Trade or Proprietary Name: | Tornier Aequalis Humeral Nail System | |
| Common or Usual Name: | Intramedullary Fixation Rod | |
| Classification Name: | Product Code: HSB | |
| 21 CFR 888.3020 | ||
| Legally Marketed Device to | ||
| Which Your Firm Is | ||
| Claiming Equivalence: | Tornier Aequalis Humeral Nail System, K082754 | |
| Description of The Device: | The Tornier Aequalis Humeral Nail System includes intramedullary nails | |
| and screws. The Tornier Aequalis Humeral Nail is a straight, cannulated | ||
| intramedullary nail with a tapered distal diameter. Nails are provided in | ||
| right and left configurations with a 9mm diameter and 130mm length. The | ||
| proximal end of the nail contains screw holes in four axes for proximal | ||
| locking using 5mm cannulated or non-cannulated screws. The proximal | ||
| end of the nail also contains a cannulated polyethylene insert with screw | ||
| holes aligned with those of the nail. This insert is intended to help prevent | ||
| the proximal screws from backing out. The distal end of the nail | ||
| incorporates one screw hole for distal locking using 4.5mm screws. The | ||
| nail and screws are manufactured from anodized Ti-6Al-4V alloy: | ||
| The purpose of this 510(k) is to add 7mm or 8mm proximal diameter nails | ||
| in lengths of 130mm, 210mm, 230mm, 250mm, and 270mm lengths to the | ||
| predicate system. | ||
| Intended Use of the Device: | The Tornier Aequalis Humeral Nail System is intended to provide | |
| temporary stabilization of various types of proximal and/or diaphyseal | ||
| fractures of the humerus. Types of fractures include, but are not limited to, | ||
| non-unions, malunions, malalignments, pathological fractures, and | ||
| impending pathological fractures. Examples of specific indications | ||
| according to AO classification include Type A-Fractures, dislocated, Type | ||
| B Fractures, dislocated; Type C-Fractures, with intact humeral head, or | ||
| Humeral Fractures according to Neer-Classification (2, 3 and 4 part | ||
| fractures). | ||
| Technological | ||
| Characteristics Compared | ||
| To Predicate Device: | The technological characteristics (material, design, sizing, indications, | |
| sterilization, and failure strength) of the Tornier Aequalis Humeral Nail | ||
| System are substantially equivalent to the predicate device. | ||
| Summary of the | ||
| Nonclinical Tests | ||
| Submitted: | Non-clinical laboratory assessment/testing was performed to evaluate the | |
| device performance per design requirements and risk analysis, including | ||
| bending calculation comparisons and torque testing. All tests met the pre- | ||
| established acceptance criteria. | ||
| Conclusions Drawn From | ||
| the Nonclinical and Clinical | ||
| Tests: | Based on risk analysis and acceptable results from testing, the Tornier | |
| Aequalis Humeral Nail System was found to be substantially equivalent to | ||
| the predicate device. |
.
. .
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
December 5, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Tornier, Incorporated Ms. Janell A. Colley Regulatory Affairs Manager 10801 Nesbitt Avenue South Bloomington, Minnesota 55437
Re: K133376
Trade/Device Name: Tornier Aequalis Humeral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: November 6, 2013 Received: November 7, 2013
Dear Ms. Colley:
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
2
Page 2 - Ms. Janell A. Colley
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark Nighterson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the word "TORNIER" in a bold, sans-serif font. To the right of the word is a hexagonal shape containing a stylized letter "T" inside. The letter "T" within the hexagon is also in a bold font and has a unique design.
Statement of Indications for Use
510(k) Number: K133376
Device Name: Tornier Aequalis Humeral Nail System
Indications for Use
The Tornier Aequalis Humeral Nail System is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).
Prescription Use X
Over-The-Counter Use
DEC 0 5 2013
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/3/Picture/11 description: The image shows a logo with the text "Casey L. Hanley, Ph.D." at the top and "Division of Orthopedic Devices" at the bottom. A horizontal line separates the two lines of text. The logo appears to be a seal or emblem, possibly associated with a medical or research institution.
Fax: (952) 426-7601 Phone: (952) 426-7600 Bloomington, MN 55437 10801 Nesbitt Avenue South