(35 days)
Not Found
No
The summary describes a mechanical plate and screw system for fracture fixation and does not mention any AI/ML components or functionalities.
No
Therapeutic devices are generally defined as devices that treat or prevent a disease or condition. This device is used for temporary internal fixation and stabilization of fractures and osteotomies, which is a structural support function rather than a direct therapeutic action on a disease process.
No
The device is described as a plate and screw system for temporary internal fixation and stabilization of osteotomies and fractures, which is a treatment modality, not a diagnostic one.
No
The device description clearly states it is a "plate and screw system intended for internal fracture fixation," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text clearly describes a "plate and screw system intended for internal fracture fixation." This is a surgical implant used to stabilize bones within the body.
- Intended Use: The intended use is for "temporary internal fixation and stabilization of osteotomies and fractures." This is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
The description of the device and its intended use firmly place it in the category of a surgical implant for orthopedic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Zimmer Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Zimmer Periarticular Locking Plate System is a plate and screw system intended for internal fracture fixation. The low-profile periarticular locking plate is anatomically contoured and has threaded holes which accept locking screws to create a stable, fixed angle construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.
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.
Zimmer ECT® Internal Fracture Fixation System, Preamendment Device, Synthes Locking Distal Radius Plating System, K012114, Synthes Distal Radius Plate System, K982732
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.
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Image /page/0/Picture/0 description: The image contains the word "zimmer" in a stylized font. To the left of the word is a circular logo with a stylized letter "Z" inside. The logo and the word "zimmer" are both in black and white. The font used for the word "zimmer" is bold and slightly condensed.
K040593
Traditional 510(k) Premarket Notification
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Laura D. Williams, RAC
Sr. Associate, Regulatory Affairs
Telephone: (574) 372-4523
Fax: (574) 372-4605 |
| Date: | March 5, 2004 |
| Trade Name: | Zimmer® Periarticular Locking Plates |
| Classification Name: | Plate, Fixation, Bone
Screw, Fixation, Bone |
| Classification Reference: | 21 CFR § 888.3030,3040 |
| Predicate Device: | Zimmer ECT® Internal Fracture Fixation System,
Preamendment Device |
| | Synthes Locking Distal Radius Plating System,
K012114, cleared 9-28-01 |
| | Synthes Distal Radius Plate System, K982732,
cleared 10-8-98 |
| Device Description: | The Zimmer Periarticular Locking Plate System is a
plate and screw system intended for internal
fracture fixation. The low-profile periarticular
locking plate is anatomically contoured and has
threaded holes which accept locking screws to
create a stable, fixed angle construct. |
| Intended Use: | The Zimmer Periarticular Locking Plate System is
indicated for temporary internal fixation and
stabilization of osteotomies and fractures, including
comminuted fractures, supracondylar fractures,
intra-articular and extra-articular condylar fractures,
fractures in osteopenic bone, nonunions, and
malunions. |
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Image /page/1/Picture/0 description: The image contains the logo for Zimmer. The logo consists of a large, bold letter 'Z' enclosed in a circle, followed by the lowercase word 'zimmer'. The 'Z' is black, and the word 'zimmer' is also black and in a sans-serif font.
| Comparison to Predicate Device: | The Zimmer Periarticular Locking Plate System has
the same intended use, has similar performance
characteristics, is manufactured from similar
materials using similar processes, and is similar in
design to the predicate devices. |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | The results of non-clinical (laboratory) performance
testing demonstrate that the device is safe and
effective. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
APR 1 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laura D. Williams, RAC Senior Associate, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K040593
Trade/Device Name: Zimmer® Periarticular Locking Plate System Regulation Numbers: 21 CFR 888.3030, 21 CFR 888.3040 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: HRS, HWC Dated: March 5, 2004 Received: March 8, 2004
Dear Ms. Williams:
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.
3
Page 2 -- Ms. Laura D. Williams, RAC
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 A. Milkum
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
4
Indications for Use
510(k) Number (if known):
Device Name:
Zimmer® Periarticular Locking Plate System
Indications for Use:
The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:
- Comminuted fractures .
- Supracondylar fractures .
- . Intra-articular and extra-articular condylar fractures
- Fractures in osteopenic bone .
- Nonunions e
- Malunions t
Mark N. Millikan
al. Restorative, Divisi and Neurologica Devices
510(k) Number K040593
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)
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