(70 days)
Not Found
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.
No
The device is a fracture fixation plate intended to stabilize calcaneal fractures, which is a supportive and corrective function, not directly therapeutic in itself.
No
The device is a fracture fixation plate designed to assist surgeons in managing calcaneal fractures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical fracture fixation plate made of Titanium, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist the surgeon in the management of... fractures of the calcaneus." This describes a surgical implant used to fix bone fractures.
- Device Description: The description details a "fracture fixation plate" made of titanium, designed to be surgically implanted to stabilize bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plates are designed to assist the surgeon in j the management of:
- Intra-articular fractures of the calcaneus .
- Extra-articular fractures of the calcaneus .
Product codes
HRS
Device Description
The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate is a fracture fixation plate intended for both intraarticular and extra-articular fractures of the calcaneus. The plate profile is an enclosed box structure with a smaller anterior section, larger posterior section, a distal to posterior angled strut for additional strength and 12 anatomically relevant screw hole locations. The plate thickness is 1mm and provides a low profile fit to reduce peroneal tendon irritation. The open architecture of the plate allows easy contouring by the surgeon to accommodate the anatomical topography of the calcaneous and also to promote fracture healing. The enclosed box structure has been shown in biomechanical testing to be stronger in intra and extra articular fractures of the calcaneous as well as analysis of the tuberosity shifting laterally and distally due to loading from the talus. The screw holes are also contourable, designed to allow low profile interaction with the heads of the following screws: 3.5mm cortical screw, 4.0mm cancellous screw, and the periarticular screw. The plate has countersinks on both sides to allow universal application of the plate; the same plate may be used on either the right or left side. The plate will be offered in two sizes: small and large. The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate is manufactured from Titanium 6Al-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
calcaneus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
The enclosed box structure has been shown in biomechanical testing to be stronger in intra and extra articular fractures of the calcaneous as well as analysis of the tuberosity shifting laterally and distally due to loading from the talus.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
2 9 1998
510(k) SUMMARY
NAME OF FIRM:
510(k) CONTACT PERSON:
TRADE NAME:
COMMON NAME:
CLASSIFICATION:
DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate
Bone Fixation Plate
DePuv ACE Medical Company
Regulatory Affairs Specialist DePuy ACE Medical Company
El Segundo, CA 90245
Kathleen Dragovich
2260 East El Segundo Boulevard
888.3030 Single/multiple component metallic bone fixation appliances and accessories
DEVICE CODE:
SUBSTANTIALLY EQUIVALENT DEVICE:
Synthes Calcaneal Plates
INTENDED USE:
The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plates are designed to assist the surgeon in the management of:
87HRS
· Intra-articular fractures of the calcaneus
Extra-articular fractures of the calcaneus .
DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:
The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate is a fracture fixation plate intended for both intraarticular and extra-articular fractures of the calcaneus. The plate profile is an enclosed box structure with a smaller anterior section, larger posterior section, a distal to posterior angled strut for additional strength and 12 anatomically relevant screw hole locations. The plate thickness is 1mm and provides a low profile fit to reduce peroneal tendon irritation. The open architecture of the plate allows easy contouring by the surgeon to accommodate the anatomical topography of the calcaneous and also to promote fracture healing. The enclosed box structure has been shown in biomechanical testing to be stronger in intra and extra articular fractures of the calcaneous as well as analysis of the tuberosity shifting laterally and distally due to loading from the talus. The screw holes are also contourable, designed to allow low profile interaction with the heads of the following screws: 3.5mm cortical screw, 4.0mm cancellous screw, and the periarticular screw. The plate has countersinks on both sides to allow universal application of the plate; the same plate may be used on either the right or left side. The plate will be offered in two sizes: small and large. The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate is manufactured from Titanium 6Al-4V ELI (per ASTM standard F136).
The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate is similar in design and function to the Synthes Calcaneal Plate (510(k) approval K915818).
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The 29 1998
Mr. Paul Doner Director, Regulatory and Clinical Affairs DePuy ACE Medical Company 2260 East El Segundo Boulevard El Segundo, California 90245-4694
K981775 Re : DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate Regulatory Class: II Product Code: HRS Dated: May 18, 1998 May 20, 1998 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
●DePuyACE™
510(k) Number (if known) _ K 981775
DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate Device Name:
Indications For User:
The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plates are designed to assist the surgeon in j the management of:
- Intra-articular fractures of the calcaneus .
- Extra-articular fractures of the calcaneus .
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use | X | OR | Over-The-Counter |
|---|---|---|---|
| (Per 21 CFR 801.109) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K981775 |
|---|---|
| --------------- | --------- |