(45 days)
Not Found
No
The summary describes a mechanical implant for fracture fixation and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as an internal fixation system for hip fractures, which is a surgical intervention to stabilize a fractured bone, not a therapeutic treatment itself.
No
The DePuy Peak Fx Hip Plate is described as an implant for internal fixation of hip fractures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly lists physical components like plates, barrel assemblies, a key, and a key screw, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "internal fixation of hip fractures." This is a surgical procedure performed on the patient's body to stabilize a broken bone.
- Device Description: The device is a physical implant (plate, barrel assemblies, screws) designed to be surgically inserted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not interact with biological specimens in this way.
This device is a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
Intended Use: The DePuy Peak Fx Hip Plate is intended for internal fixation of hip fractures.
The Peak Fx Hip Plate is indicated for the following fractures of the proximal femur:
- . Basilar neck fractures
- . Intertrochanteric fractures
- . Subtrochanteric fractures
The Peak Fx Hip Plate is indicated for stable and unstable fractures in which a stable medial buttress can be reconstructed.
Product codes (comma separated list FDA assigned to the subject device)
87 KTT, KTT, HRS
Device Description
The DePuy Peak Fx Hip Plate System is comprised of plates in various lengths with two to twelve holes, barrely assemblies in various lengths with angles from 125° to 140°, a key and key screw, and a limited collapse caro.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur
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
§ 888.3030 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
510 (k) Summary
JAN - 4 2007
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46582
Establishment Registration Number: 1818910 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Rhonda Myer
Regulatory Affairs
Telephone: (574) 371-4927
Facsimile: (574) 371-4987
Electronic Mail: Rmyer7@dpyus.jnj.com |
| DATE PREPARED: | November 6, 2006 |
| PROPRIETARY NAME: | Peak Fx Hip Plate |
| COMMON NAME: | Bone Screw and Plate for Internal Fixation |
| CLASSIFICATION: | Class II device per 21 CFR 888.3030:
Single/Multiple component metallic bone fixatio
appliances and accessories |
| DEVICE PRODUCT CODE: | 87 KTT |
| SUBSTANTIALLY EQUIVALENT
DEVICES: | DePuy Captured Hip Screw System (CHS),
K813554, cleared on January 12, 1982 |
DEVICE DESCRIPTION:
The DePuy Peak Fx Hip Plate System is comprised of plates in various lengths with two to twelve holes, barrely assemblies in various lengths with angles from 125° to 140°, a key and key screw, and a limited collapse caro.
INTENDED USE AND INDICATIONS:
Intended Use: The DePuy Peak Fx Hip Plate is intended for internal fixation of hip fractures.
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Indications for Use:
The Peak Fx Hip Plate is indicated for the following fractures of the proximal femur:
- . Basilar neck fractures
- . Intertrochanteric fractures
- . Subtrochanteric fractures
The Peak Fx Hip Plate is indicated for stable and unstable fractures in which a stable medial buttress can be reconstructed.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The substantial equivalence of the DePuy Peak Fx Hip Plate is shown by its similarity in intended use, indications for use, materials and design to the existing DePuy Captured Hip Screw System (CHS), K813554, cleared on January 12, 1982.
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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 features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is in a smaller, lighter font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. % Ms. Rhonda Myer Regulatory Associate, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46582
JAN 0 4 2007
Re: K063509
Trade/Device Name: Peak Fx Hip Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, HRS Dated: November 17, 2006 Received: November 20, 2006
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, Orug, 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, TDA more 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 100-1000,
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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 (240) 276-0210 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .
Sincerely yours,
Mark N. Melkerson 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, a Johnson & Johnson company. The logo features a black circle to the left of the name "DePuy" in a stylized font. A horizontal line underlines the name, and below that, the text "a Johnson & Johnson company" is written in a smaller font. The logo is simple and professional, reflecting the company's corporate identity.
DePuy Orthopaedics, Inc.
PO Box 988 700 Orthopaedic Drive Warsaw, IN 46581-0988 USA Tel: +1 (574) 267 8143 Fax: +1 (574) 371 4987
Indications for Use Statement
| 510 (k) Number (if known): | K063509 |
|---|---|
| ---------------------------- | --------- |
Device Name:
Indications for Use:
The Peak Fx Hip Plate is indicated for the following fractures of the proximal femur:
- Basilar neck fractures .
- Intertrochanteric fractures ●
- . Subtrochanteric fractures
The Peak Fx Hip Plate is indicated for stable and unstable fractures in which a stable medial buttress can be reconstructed.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line. Continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
54000 Number.
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