(90 days)
Not Found
No
The summary describes a physical orthopedic plate and does not mention any software, algorithms, or data processing related to AI/ML.
No.
The device is an orthopedic plate used to assist in the management of calcaneus fractures, which is a supportive and reparative function rather than direct therapy.
No
Explanation: The device, the DePuy ACE Calcaneal Peri-Articular Plate, is described as a plate designed to assist surgeons in managing calcaneal fractures. This indicates its function as a surgical implant or aid, not a tool for diagnosing medical conditions.
No
The device description clearly describes a physical plate structure 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The DePuy ACE Calcaneal Peri-Articular Plates are surgical implants designed to fix bone fractures. They are physically placed within the body during surgery.
- Intended Use: The intended use is to assist surgeons in managing calcaneal fractures, which is a surgical procedure, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The Calcaneal Peri-Articular Plate is designed to assist the surgeon in the management of the following:
- Intra-articular fractures of the calcaneus ●
- . Extra-articular fractures of the calcaneus
Product codes (comma separated list FDA assigned to the subject device)
87 HRS
Device Description
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 a number of anatomically relevant screw hole locations. The plate provides a low profile fit to reduce peroneal tendon irritation.
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)
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
§ 888.3030 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
Image /page/0/Picture/0 description: The image shows a handwritten sequence of characters and numbers. The first line contains the characters 'K' and the numbers '993465'. The second line contains the numbers '1', '08', and '2'.
Image /page/0/Picture/1 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo consists of a black circle to the left of the word "DePuy" in a bold, sans-serif font. A horizontal line underlines the word "DePuy". Below the line, the text "a Johnson & Johnson company" is written in a smaller, serif font.
JAN 1 1 2000
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Arlene C. Saull, RAC
Sr. Submissions Associate
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, IN 46581-0988 |
| TRADE NAME: | DePuy ACE Calcaneal Peri-Articular Plate |
| COMMON NAME: | Bone Fixation Plate |
| CLASSIFICATION: | Class II, per 21 CFR, 888.3030: Single/multiple
component metallic bone fixation appliances and
accessories. |
| DEVICE PRODUCT CODE: | 87 HRS Plate, Fixation, Bone |
| SUBSTANTIALLY EQUIVALENT DEVICES: | DePuy ACE Calcaneal Peri-Articular Plate
Synthes Calcaneal Plate |
INTENDED USE AND DEVICE DESCRIPTION:
The Calcaneal Peri-Articular Plate is designed to assist the surgeon in the management of the following:
- Intra-articular fractures of the calcaneus ●
- . Extra-articular fractures of the calcaneus
1
Image /page/1/Picture/0 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo consists of a black circle to the left of the name "DePuy" in a bold, sans-serif font. Below the name is a horizontal line, and below that is the text "a Johnson+Johnson company" in a smaller, serif font. The logo is simple and professional, and it clearly identifies the company and its parent company.
2wt a
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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 a number of anatomically relevant screw hole locations. The plate provides a low profile fit to reduce peroneal tendon irritation.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The subject devices are essentially identical (except for size) to the predicate DePuy ACE calcaneal plate devices cleared by 510(k) on July 29, 1998, in that both are made from the same material; the indications remain the same and the design is essentially the same. The subject DePuy ACE calcaneal plates are similar in design and function to the predicate Synthes Calcaneal Plate (510(k) K915818). Based on the information provided in this premarket notification, DePuy considers the subject devices to be substantially equivalent to the existing DePuy ACE Calcaneal Plates and the Synthes calcaneal plates.
R:\Clinical\reg\510\1999\ACE Calcaneal PerimeterPlate\7S&ESummary
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 2000
Ms. Arlene C. Saull, RAC Senior Regulatory Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
K993465 Re:
Trade Name: DePuy ACE Calcaneal Peri-Articular Plate Regulatory Class: II Product Code: HRS Dated: October 12, 1999 Received: October 13, 1999
Dear Ms. Saull:
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 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 (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 action. In addition, FDA may publish further announcements 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.
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
3
Page 2 - Ms. Arlene C. Saull, RAC
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Russell W. Sage
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS
| 510(k) Number (if known) | K993465 |
|---|---|
| -------------------------- | --------- |
DePuy ACE Calcaneal Peri-Articular Plate Device Name
Indications for Use:
The DePuy ACE Calcaneal Peri-Articular Plates are designed to assist the surgeon in the management of:
10월6월부출일부분전문조국제조사노트------------------------------------
- Intra-articular fractures of the calcaneus ●
- Extra-articular fractures of the calcaneus ●
R:\ClinicalVeg\510\1999\ACE CalcancalPe
Concurrence of CDRH, Office of Device Evaluation:
Vernel // Dager sir Jrs
(Division Sign-Off) Division of General Restorative Devices 510(k) Number .
Image /page/4/Picture/11 description: The image shows the words "Prescription Use" in a bold, serif font. To the right of the words, there is a large "X" that appears to be marking the "Prescription Use" option. The "X" is drawn with thick lines and extends slightly beyond the baseline of the text. The image suggests that the item in question is intended for prescription use.
OR
Over-The Counter Use (Per 21 CFR 801.109)