(31 days)
No
The device description and intended use are solely focused on a mechanical intramedullary nail for bone fixation. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML.
Yes
The device is described as an "intramedullary nail" for "internal fixation of tibial fractures," which directly addresses a health condition (fractures) and aims to restore function, aligning with the definition of a therapeutic device.
No
Explanation: The provided text describes the DePuy Ace™ VersaNail Tibial Nail as an intramedullary nail for internal fixation of tibial fractures and reconstructive surgeries. Its purpose is to physically stabilize bones, not to diagnose medical conditions or analyze data to detect diseases.
No
The device description clearly describes a physical intramedullary nail made of metal, which is a hardware component, not software.
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, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The DePuy Ace™ VersaNail Tibial Nail is a physical implantable device (an intramedullary nail) used for the internal fixation of bone fractures. It is surgically inserted into the tibia to stabilize broken bones.
- Lack of Specimen Analysis: The description and intended use clearly indicate that this device does not involve the analysis of any specimens taken from the body. It is a mechanical device used directly on the bone.
Therefore, based on the provided information, the DePuy Ace™ VersaNail Tibial Nail falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The DePuy Ace™ VersaNail Tibial Nail is indicated for the internal fixation of tibial fractures including transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, fractures with bone loss, bone transport, open fractures, corrective osteotomies, pathologic fractures, pseudarthrosis of the tibial shaft, nonunions, malunions, metaphyseal fractures and epiphyseal fractures.
The Tibial Nail is intended for bone fixation in the management of fractures and reconstructive surgeries.
Non-weight bearing bone fixation is indicated in the following conditions:
- Transverse, oblique, spiral, segmental and comminuted fractures;
- Fractures with bone loss and bone transport;
- Open fractures, pathologic fractures;
- Corrective osteotomies;
- Pseudarthrosis of the tibial shaft;
- Nonunions, malunions, metaphyseal and epiphyseal fractures.
Product codes
87 HSB
Device Description
The DePuy Ace™ VersaNail Tibial Nail is a cannulated intramedullary nail available in diameters of 8mm, 9mm, 11mm, 12mm and 13mm, and lengths of 24.0cm to 43.5cm. There are two holes on the proximal end and three holes on the distal end of the nail that allow for cortical bone screw locking. Screw hole diameters are 5.97mm at the proximal and distal ends respectively. The proximal end of the nail also features a 13mm medial/lateral (M/L) slot for dynamization, and an 8-degree bend with a bend radius of approximately 2.25mm. The distal end also has a bend radius of approximately 2.25mm and has a bullet tip. The DePuy Ace™ VersaNail Tibial Nail is intended for intramedullary fixation of tibial fractures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibial shaft
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)
Not Found
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
AUG - 8 2003
K 032097
page 1 of 1
SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Ace™ Orthopaedics, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, IN 46581-0988 |
|-------------------------------------|-------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Tiffani Rogers
Clinical Research Specialist, Clinical/Regulatory
Affairs |
| TRADE NAME: | DePuy Ace™ Versa Nail Tibial Nail |
| COMMON NAME: | Intramedullary Rod |
| CLASSIFICATION: | 888.3020: Rod, Fixation, Intramedullary and
Accessories; Class II |
| DEVICE PRODUCT CODE: | 87 HSB |
| SUBSTANTIALLY EQUIVALENT
DEVICE: | DePuy Ace™ Bio Win Tibial Nail, K013430 |
DEVICE DESCRIPTION:
The DePuy Ace™ VersaNail Tibial Nail is a cannulated intramedullary nail available in diameters of 8mm, 9mm, 11mm, 12mm and 13mm, and lengths of 24.0cm to 43.5cm. There are two holes on the proximal end and three holes on the distal end of the nail that allow for cortical bone screw locking. Screw hole diameters are 5.97mm at the proximal and distal ends respectively. The proximal end of the nail also features a 13mm medial/lateral (M/L) slot for dynamization, and an 8-degree bend with a bend radius of approximately 2.25mm. The distal end also has a bend radius of approximately 2.25mm and has a bullet tip. The DePuy Ace™ VersaNail Tibial Nail is intended for intramedullary fixation of tibial fractures.
INTENDED USE AND INDICATIONS:
The DePuy Ace™ VersaNail Tibial Nail is indicated for the internal fixation of tibial fractures including transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, fractures with bone loss, bone transport, open fractures, corrective osteotomies, pathologic fractures, pseudarthrosis of the tibial shaft, nonunions, malunions, metaphyseal fractures and epiphyseal fractures.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Ace™ VersaNail Tibial Nail has the same indications and contraindications as the DePuy Ace™ Bio Win Tibial Nail cleared in K013430 with a similar design. The sole differences between the two designs are: modification of the proximal hole pattern; increase in cannulation; modification of the distal hole pattern; the removal of the optional bioresorbable window available with the DePuy Ace™ Bio Win nail and a smaller size, 24.0cm, will be available for smaller stature adults. The proximal and distal ends of the nail were modified to accommodate the use of a new jig bolt instrument and a ball nose guide wire instead of the exchange tube and nail driving wire used with the DePuy Ace™ Bio Win nail.
1
Image /page/1/Picture/1 description: The image shows a circular seal or logo. The seal features a stylized design of three curved lines, possibly representing wings or waves, on the right side. The text curves around the top and bottom of the circle, but the text is not legible due to the image quality. The overall impression is that of an official emblem or symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2003
Ms. Tiffani D. Rogers Clinical Research Specialist Clinical/Regulatory Affairs Depuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581
Re: K032097
Trade/Device Name: DePuy Ace™ VersaNail Tibial Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: July 1, 2003 Received: July 16, 2003
Dear Ms. Rogers:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
2
Page 2 - Ms. Tiffani D. Rogers
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
o Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known) Ko
Device Name DePuy Ace™ VersaNail Tibial Nail
Inter.ded Use and Indications:
The Tibial Nail is intended for bone fixation in the management of fractures and reconstructive surgeries.
Non-weight bearing bone fixation is indicated in the following conditions:
- Transverse, oblique, spiral, segmental and comminuted fractures; ●
- Fractures with bone loss and bone transport; ●
- Open fractures, pathologic fractures;
- Corrective osteotomies;
- Pseudarthrosis of the tibial shaft; ●
- Nonunions, malunions, metaphyseal and epiphyseal fractures.
#서비스========================================================================================================================================================================= Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use A o
Miriam C. Provost
eneral. Restorative and Neurological De
510(k) Number K032697