(29 days)
Not Found
No
The document describes a mechanical intramedullary nail system for fracture fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is an intramedullary nail system used to treat various bone fractures, non-unions, and malunions, which are conditions addressed by therapeutic interventions.
No
Explanation: The device is an intramedullary nail system designed to treat bone fractures and other orthopedic conditions. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is an intramedullary nail system made of metal, which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the surgical treatment of bone fractures and other conditions of the femur. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details an intramedullary nail system, screws, and end caps, all made of titanium alloy. These are surgical implants, not reagents or instruments used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro methods, or providing information for diagnosis, monitoring, or screening.
Therefore, the DePuy ACE® Universal and Troch Entry Femoral Nail System is a surgical implant/device used for orthopedic procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy ACE® Universal and Troch Entry Femoral Nail System is intended to treat proximal, middle and distal third fractures, severely comminuted shaft fractures extending beyond the isthmus, spiral, long oblique and segmental fractures, non-unions and malunions, lengthening of the bone, fractures with bone loss, bi-lateral fractures, pseudoarthrosis of the femoral shaft, supracondylar fractures, subtrochanteric fractures, with or without involvement of lesser trochanter, subtrochanteric/intertrochanteric combination fractures, ipsilateral femoral shaft and neck fractures, stable and unstable proximal fractures of the femur, including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, proximal or distal non-unions and malunions, leg length discrepancies secondary to femoral inequality, femur reconstruction following tumor resection, stable femoral fractures without necessity for interlocking, long subtrochanteric fractures, and revision procedures involving the replacement of implanted hardware.
In addition to the above indications, the Universal Nail, when used in the retrograde mode, is also indicated for treatment of femoral shaft fractures in obese or multiple trauma patients and supracondylar fractures, including those with severe, extra-articular comminution and/or intra-articular involvement, osteoporosis, non-unions, malunions, pathologic fractures, and those proximal to total knee prosthesis.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The DePuy ACE® Universal Nail is a revision of the ACE® AIM Femoral Nail (K871539). The Universal Nail is a slightly bowed intramedullary nail with proximal holes and distal lateral / medial holes and anterior/ posterior holes. The nail is "universal" in design, as it requires no right or left device configurations. It is designed to be inserted in either an antegrade or retrograde approach. The nail sizes include 8mm through 15mm diameters and lengths of 280mm through 500mm.
The Troch Entry Nail (TEN) is similar in design to the ACE® Trochanteric Nail System (K010780) and the ACE® Long Trochanteric Nail System (K013563). The Troch Entry Nail is a slightly bowed femoral intramedullary nail with proximal and distal holes. It is intended for antegrade insertion only. This nail includes a small proximal bend for insertion just lateral to the tip of the greater trochanter. Due to this bend, the nail designs require a right and left anatomic version. This nail system includes 9mm, 11mm and 13mm diameters in lengths of 280mm through 500mm in right and left versions.
The Nail System includes intramedullary nails, screws, and end caps. All components are manufactured from ASTM F-136 Ti 6A1-4V alloy with titanium type II anodise (TiMaxTM).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral shaft, femur, trochanteric and diaphyseal areas.
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.
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
K033329
SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy ACE®
P.O. Box 988
700 Orthopaedic Drive
Warsaw, IN 46581-0988 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Rhonda Myer
Regulatory Affairs |
| TRADE NAME: | DePuy ACE® Universal and Troch Entry
Femoral Nail Systems |
| COMMON NAME: | Intramedullary Rod |
| CLASSIFICATION: | 888.3030: Single/multiple component metallic
bone fixation appliances and accessories; Class
II |
| DEVICE PRODUCT CODE: | 87 HSB |
| SUBSTANTIALLY EQUIVALENT
DEVICES: | DePuy ACE® AIM Femoral Nail (K871539)
DePuy ACE® Trochanteric Nail System
(K010780)
DePuy ACE® Long Trochanteric Nail System |
DEVICE DESCRIPTION:
The DePuy ACE® Universal Nail is a revision of the ACE® AIM Femoral Nail (K871539). The Universal Nail is a slightly bowed intramedullary nail with proximal holes and distal lateral / medial holes and anterior/ posterior holes. The nail is "universal" in design, as it requires no right or left device configurations. It is designed to be inserted in either an antegrade or retrograde approach. The nail sizes include 8mm through 15mm diameters and lengths of 280mm through 500mm.
(K013563)
The Troch Entry Nail (TEN) is similar in design to the ACE® Trochanteric Nail System (K010780) and the ACE® Long Trochanteric Nail System (K013563). The Troch Entry Nail is a slightly bowed femoral intramedullary nail with proximal and distal holes. It is intended for antegrade insertion only. This nail includes a small proximal bend for insertion just lateral to the tip of the greater trochanter. Due to this bend, the nail designs require a right and left anatomic version. This nail system includes 9mm, 11mm and 13mm diameters in lengths of 280mm through 500mm in right and left versions.
The Nail System includes intramedullary nails, screws, and end caps. All components are manufactured from ASTM F-136 Ti 6A1-4V alloy with titanium type II anodise (TiMaxTM).
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3
1
Ko33329
INTENDED USE AND INDICATIONS:
The DePuy ACE® Universal and Troch Entry Femoral Nail System is intended to treat proximal, middle and distal third fractures, severely comminuted shaft fractures extending beyond the isthmus, spiral, long oblique and segmental fractures, non-unions and malunions, lengthening of the bone, fractures with bone loss, bi-lateral fractures, pseudoarthrosis of the femoral shaft, supracondylar fractures, subtrochanteric fractures, with or without involvement of lesser trochanter, subtrochanteric combination fractures, ipsilateral femoral shaft and neck fractures, stable and unstable proximal fractures of the femur, including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, proximal or distal non-unions and malunions, leg length discrepancies secondary to femoral inequality, femur reconstruction following tumor resection, stable femoral fractures without necessity for interlocking, long subtrochanteric fractures, and revision procedures involving the replacement of implanted hardware.
In addition to the above indications, the Universal Nail, when used in the retrograde mode, is also indicated for treatment of femoral shaft fractures in obese or multiple trauma patients and supracondylar fractures, including those with severe, extra-articular comminution and/or intra-articular involvement, osteoporosis, non-unions, malunions, pathologic fractures, and those proximal to total knee prosthesis.
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Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with two snakes coiled around it, topped with a pair of wings.
Public Health Service
NOV 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rhonda Myer Regulatory Affairs DePuy, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K033329
Trade/Device Name: DePuy ACE® Universal and Troch Entry Femoral Nail Systems Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: II Product Code: HSB Dated: October 14, 2003 Received: October 16, 2003
Dear Ms. Myer:
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 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.
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Page 2 - Ms. Rhonda Myer
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. 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 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,
Mark M. Millenn
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
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Image /page/4/Picture/0 description: The image shows the logo for DePuy ACE, a Johnson & Johnson company. The logo features a black circle followed by the words "DePuy ACE" in a bold, sans-serif font. Underneath the company name is the text "a Johnson-Johnson company" in a smaller, cursive font.
DePuy ACE
PO Box 988 700 Orthopaedic Drive Warsaw. Indiana 46581-0988 ાં નિર્મ Tel. +1 :574) 267 8143 Fax. + 1 (574) 267 7098
510(k) Number (if known): _ K033329
Device Name: DePuy ACE® Universal and Troch Entry Femoral Nail System
Intended Use and Indications:
The DePuy ACE® Universal and Troch Entry Femoral Nail System is intended to treat proximal. middle and distal third fractures, severely comminuted shaft fractures extending beyond the isthmus, spiral, long oblique and segmental fractures, non-unions and malunions, lengthening of the bone, fractures with bone loss, bi-lateral fractures, pseudoarthrosis of the femoral shaft, supracondylar fractures, subtrochanteric fractures, with or without involvement of lesser trochanter, subtrochanteric/intertrochanteric combination fractures, ipsilateral femoral shaft and neck fractures, stable and unstable proximal fractures of the femur, including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, proximal or distal non-unions and malunions, leg length discrepancies secondary to femoral inequality, femur reconstruction following tumor resection, stable femoral fractures without necessity for interlocking, long subtrochanteric fractures, and revision procedures involving the replacement of implanted hardware.
In addition to the above indications, the Universal Nail, when used in the retrograde mode, is also indicated for treatment of femoral shaft fractures in obese or multiple trauma patients and supracondylar fractures, including those with severe, extra-articular comminution and/or intra-articular involvement, osteoporosis, non-unions, malunions, pathologic fractures, and those proximal to total knee prosthesis.
Image /page/4/Picture/8 description: The image contains a signature and some text. The signature appears to be "Mark N Millam". The text below the signature includes the words "Men-Off", "General, Restorative", and "Neurological Devices". The text seems to be related to medical devices.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use
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