(90 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a standard intramedullary nail, with no mention of AI or ML capabilities.
Yes
The device is a VersaNail™ intended for use in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia, addressing various medical conditions such as arthrosis, avascular necrosis, and deformities. This aligns with the definition of a therapeutic device designed to cure, mitigate, treat, or prevent disease.
No
Explanation: The device description and intended use clearly state that the VersaNail™ is an intramedullary nail designed for surgical intervention (fusions and treatment of trauma) in the hindfoot and distal tibia, addressing various orthopaedic conditions. It is a treatment device, not one used for diagnosis.
No
The device description clearly states it is a physical intramedullary nail made of Ti-6AL-4V alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- VersaNail™ Function: The VersaNail™ is an implantable surgical device used to stabilize bones during fusion procedures in the hindfoot and distal tibia. It is a physical device inserted into the body, not a tool for analyzing biological samples.
The provided information clearly describes a surgical implant for orthopedic procedures, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The VersaNail™ is intended for use in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia. Indications include: revision after failed ankle arthrodesis with subtalar involvement; absent talus (tibiocalcaneal arthrodesis); post traumatic or primary arthrosis involving both ankle and subtalar joints; rheumatoid hindfoot; avascular necrosis of the talus; previously infected arthrosis, second degree; failed total ankle arthroplasty. Indications also include non-union ankle arthrodesis; osteoarthritis; post-traumatic and degenerative arthritis; neuroarthropathy or neuropathic ankle deformity; neuromuscular disease with severe deformity and Charcot foot.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The VersaNail™ is a straight, cannulated intramedullary nail available in diameters of 10 and 12 mm and lengths of 15, 20, 25 and 30 cm. Holes in the nail allow for proximal and distal locking. The VersaNail™, the end cap and the screws are all manufactured from Ti-6AL-4V alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hindfoot, distal tibia, ankle, subtalar joints
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K974781, K003797, K982953, K991790, K983942
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k): ACE® VersaNail™
KONSILS
page
10 t
510(k) Summary
| Name of Sponsor: | DePuy ACE®, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Est. Reg. No. 1818910 | DEC 1 8 2002 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| 510(k) Contact: | Dina L. Weissman, J.D.
Legal consultant, Regulatory Affairs
Phone: (574) 371-4905
FAX: (574) 371-4987 | |
| Trade Name: | ACE® VersaNail™ | |
| Common Name: | Intramedullary Fixation Rod | |
| Classification: | Class II Device per 21 CFR 888.3020:
Rod, Fixation, Intramedullary and Accessories | |
| Device Product Code: | 87HSB | |
| Substantially Equivalent Devices: | ACE® AIM® Titanium Supracondylar Nail
ACE® AIM® TTC Fusion Nail
Biomet Ankle Arthrodesis Nail
Encore® UltiMax Ankle Fusion Rod
Smith and Nephew Intramedullary Nail | K974781
K003797
K982953
K991790
K983942 |
| Device Description: | The VersaNail™ is a straight, cannulated intramedullary nail
available in diameters of 10 and 12 mm and lengths of 15, 20, 25
and 30 cm. Holes in the nail allow for proximal and distal
locking. The VersaNail™, the end cap and the screws are all
manufactured from Ti-6AL-4V alloy. | |
| Intended use: | The VersaNail™ is intended for use in tibiotalocalcaneal
fusions and treatment of trauma to the hindfoot and distal
tibia. | |
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023115
page 2 of 2
510(k) Summary (continued)
Indications include: revision after failed ankle arthrodesis with Indications for use: subtalar involvement; absent talus (tibiocalcaneal arthrodesis); post traumatic or primary arthrosis involving both ankle and subtalar joints; rheumatoid hindfoot; avascular necrosis of the talus; previously infected arthrosis, second degree; failed total ankle arthroplasty. Additional indications also include nonunion ankle arthrodesis; osteoarthritis; post-traumatic and degenerative arthritis; neuroarthropathy or neuropathic ankle deformity; neuromuscular disease with severe deformity and Charcot foot.
This submission covers these additional indications for use: non-union ankle arthrodesis; osteoarthritis; post-traumatic and degenerative arthritis; neuroarthropathy or neuropathic ankle deformity; neuromuscular disease with severe deformity and Charcot foot.
These indications have been cleared previously for the Biomet Ankle Arthrodesis Nail, the Smith and Nephew Intramedullary Nail and/or the Encore® UltiMax Ankle Fusion Rod.
Based on similarities of design, commonly used materials, Substantial equivalence: identical sterilization processes, and indications for use, DePuy believes the ACE® VersaNail™ to be substantially equivalent to the following FDA cleared devices: the ACE AIM® Titanium Supracondylar Nail, the ACE® AIM® TTC Fusion Nail, the Biomet Ankle Arthrodesis Nail, the Smith and Nephew Intramedullary Nail and the Encore® UltiMax Ankle Fusion Rod.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three wavy lines extending from the head, representing the flow of ideas and services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the figure.
Public Health Service
Food and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2002
Ms. Dina L. Weissman, J.D. Legal Consultant, Regulatory Affairs DePuy ACE, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988.
Re: K023115
Trade/Device Name: ACE® VersaNail™ Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 18, 2002 Received: September 19, 2002
Dear Ms. Weissman:
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);
3
Page 2 - Ms. Dina L. Weissman, J.D.
labeling (21 CFR Part 801): 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.
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) 594-4659. Additionally, for questions on the promotion and advertising of your device, 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). 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.
Muriam C. Provost
forCelia 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
4
510(k) Number (if known):
ACE® VersaNail Device Name:
Indications for Use:
The VersaNail™ is intended for use in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia. Indications include: revision after failed ankle arthrodesis with subtalar involvement; absent talus (tibiocalcaneal arthrodesis); post traumatic or primary arthrosis involving both ankle and subtalar joints; rheumatoid hindfoot; avascular necrosis of the talus; previously infected arthrosis, second degree; failed total ankle arthroplasty. Indications also include non-union ankle arthrodesis; osteoarthritis; post-traumatic and degenerative arthritis; neuroarthropathy or neuropathic ankle deformity; neuromuscular disease with severe deformity and Charcot foot.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Muriane C. Provost
ivision Sign-Off) Vivision of General, Restorative and Neurological Devices
Number K0231/5