(19 days)
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No
The device description focuses on the mechanical properties and design of a fracture fixation plate, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The "DePuy ACE TiMAX™ Medial Pilon Plate" is explicitly described as a "fracture fixation plate intended for use in pilon fractures... high medial malleolar fractures, and low boot type rotational distal extra-articular tibial shaft fractures," which directly indicates its purpose in treating medical conditions.
No
Explanation: The device is a fracture fixation plate, which is a surgical implant used to stabilize broken bones, not to diagnose medical conditions.
No
The device description clearly describes a physical fracture fixation plate made of Titanium, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The DePuy ACE TiMAX™ Medial Pilon Plate is a fracture fixation plate. It is a physical implant used to stabilize broken bones.
- Intended Use: The intended use is to fix specific types of fractures in the distal tibia and medial malleolus. This is a surgical procedure performed directly on the patient's body, not on a specimen outside the body.
The description clearly indicates a surgical implant used for orthopedic procedures, which falls under the category of medical devices, but not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
- Pilon fractures distal tibial intra-articular fractures
- High medial malleolar fractures
- Low boot top type rotational distal extra-articular shaft fractures
Product codes
HSB
Device Description
The DePuy ACE TiMAX™ Medial Pilon Plate is a fracture fixation plate intended for use in pilon fractures (distal tibial intra-articular fractures), high medial malleolar fractures, and low boot type rotational distal extra-articular tibial shaft tractures. The plate profile consists of a shaft portion with compression slots, a diamond-shaped structure with three screw holes and a central cutout. There are also two k-wire guide holes for the distal metaphyseal region and a partial hole with countersink in the distal end of the cutout. The plate thickness is 1.6 mm in the shaft region and is decreased to 1 mm in the distal region to facilitate contouring and maintaining anatomic reduction of the fracture. The plate is supplied with a form along the long axis of the plate and the surgeon is expected to complete the contouring to match the individual patient anatomy. The open architecture of the distal region allows easy contouring by the surgeon to accommodate the anatomical topography of the distal tibia and also to promote fracture healing. The screw holes have been designed to allow low profile interaction with the heads of the following screws: 3.5mm cortical screw and 4.0mm cancellous screw. The plate is a universal plate and can be used on the right or left tibia. The DePuy ACE TiMAX™ Medial Pilon Plate is manufactured from Titanium 6A1-4V ELI (per ASTM standard F136).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal tibial, medial malleolar
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
DePuy ACE TiMAX" Medial Pilon Plate is a minor modification to the DePuy ACE TiMAX" Pilon Plate and has been shown to have similar strength and bending properties.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
DePuy ACE TiMAX™ Pilon Plate
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
FEB 1 1999
Image /page/0/Picture/1 description: The image shows the logo for DePuy ACE. Below the logo, the text "K990120" is written in a handwritten style. The logo consists of a black circle followed by the text "DePuy ACE" in a bold, sans-serif font.
510(k) SUMMARY
NAME OF FIRM:
510(k) CONTACT PERSON:
TRADE NAME:
COMMON NAME:
CLASSIFICATION:
DEVICE CODE:
87HRS
SUBSTANTIALLY EQUIVALENT DEVICE:
DePuy ACE TiMAX™ Pilon Plate
fixation appliances and accessories.
DePuy ACE Medical Company 2260 East El Segundo Boulevard
Regulatory Affairs Specialist DePuy ACE Medical Company
DePuy ACE TiMAX™ Medial Pilon Plate
888.3030 Single/multiple component metallic bone
El Segundo, CA 90245
Kathleen Dragovich
Bone Fixation Plate
INTENDED USE:
- · Pilon fractures distal tibial intra-articular fractures
- High medial malleolar fractures
- · Low boot top type rotational distal extra-articular shaft fractures
DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:
The DePuy ACE TiMAX™ Medial Pilon Plate is a fracture fixation plate intended for use in pilon fractures (distal tibial intra-articular fractures), high medial malleolar fractures, and low boot type rotational distal extra-articular tibial shaft tractures. The plate profile consists of a shaft portion with compression slots, a diamond-shaped structure with three screw holes and a central cutout. There are also two k-wire guide holes for the distal metaphyseal region and a partial hole with countersink in the distal end of the cutout. The plate thickness is 1.6 mm in the shaft region and is decreased to 1 mm in the distal region to facilitate contouring and maintaining anatomic reduction of the fracture.
The plate is supplied with a form along the long axis of the plate and the surgeon is expected to complete the contouring to match the individual patient anatomy. The open architecture of the distal region allows easy contouring by the surgeon to accommodate the anatomical topography of the distal tibia and also to promote fracture healing. The screw holes have been designed to allow low profile interaction with the heads of the following screws: 3.5mm cortical screw and 4.0mm cancellous screw. The plate is a universal plate and can be used on the right or left tibia.
The DePuy ACE TiMAX™ Medial Pilon Plate is manufactured from Titanium 6A1-4V ELI (per ASTM standard F136).
DePuy ACE TiMAX" Medial Pilon Plate is a minor modification to the DePuy ACE TiMAX" Pilon Plate and has been shown to have similar strength and bending properties.
Based on the above information, DePuy ACE Medical Company firmly believes that the new DePuy ACE TiMAX™ Medial Pilon Plate is substantially equivalent to the DePuy ACE TiMAX™ Pilon Plate.
2
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem featuring a stylized depiction of an eagle or bird with three wing-like lines above a wavy line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1999 FEB
Mr. Paul Doner Director, Regulatory and Clinical Affairs DePuy Ace Medical Company 2260 East El Segundo Boulevard El Segundo, California 90245-4694
Re: K990120 DePuy ACE TiMAX™ Medical Pilon Plate Requlatory Class: II Product Code: HSB Dated: January 12, 1999 January 13, 1999 Received:
Dear Mr. Doner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Paul Doner
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Stepten Rhodes
elia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo for DePuy ACE. The logo consists of a black circle followed by the text "DePuy ACE" in a bold, sans-serif font. The letters are all capitalized, and the "TM" symbol is present in the bottom right corner of the "E" in "ACE."
| 510(k) Number (if known) | |
|---|---|
DePuy ACE TiMAX™ Medial Pilon Plate Device Name:
Indications for Use:
- Pilon fractures distal tibial intra-articular fractures
- High medial malleolar fractures
- Low boot top type rotational distal extra-articular shaft fractures
Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K990120 |
|---|---|
| --------------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter | |
|---|---|---|---|
| ------------------------------------------ | ---------------------------------------------------------------------------- | ---- | ------------------ |