(25 days)
Not Found
No
The summary describes a mechanical plate and screw system for fracture fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is indicated for "temporary internal fixation and stabilization" of various types of fractures and nonunions/malunions, which is a therapeutic intervention.
No
The device is described as a "plate and screw system intended for internal fracture fixation," which clearly indicates it is a therapeutic device used for physical stabilization of fractures, not for diagnosing medical conditions.
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:
- Intended Use: The intended use clearly states "temporary internal fixation and stabilization of osteotomies and fractures". This describes a surgical implant used to physically support and stabilize bone, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a "plate and screw system intended for internal fracture fixation". This further reinforces its role as a physical implant for bone repair.
- Lack of IVD Characteristics: An IVD device would typically involve:
- Analyzing samples (blood, urine, tissue, etc.).
- Providing information about a patient's health status, disease, or condition.
- Using reagents or other materials to perform a test.
The provided information describes a surgical implant, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / 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 .
- Malunions .
Product codes
HRS
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)
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
Image /page/0/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo consists of a large, bold letter "Z" inside of a circle, followed by the word "zimmer" in a smaller, sans-serif font. The logo is black and white.
IAN 2 】 2005
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Laura D. Williams, RAC
Manager, Corporate Regulatory Affairs
Telephone: (574) 372-4523
Fax: (574) 372-4605 |
| Date: | December 23, 2004 |
| Trade Name: | Zimmer® Periarticular Locking Plate System |
| Classification Name: | Plate, Fixation, Bone
Screw, Fixation, Bone |
| Classification Reference: | 21 CFR § 888.3030,3040 |
| Predicate Device: | Zimmer Periarticular Locking Plate System,
K040593, cleared April 12, 2004 |
| 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 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. |
| Comparison to Predicate Device: | The Zimmer Periarticular Locking Plate System has
the same intended use, has similar performance
characteristics, operates using the same fundamental
scientific technology, is manufactured from the
same materials using the same processes, and is
similar in design to the predicate device. |
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Image /page/1/Picture/1 description: The image contains the word "zimmer" in bold, sans-serif font. To the left of the word is a circular logo. The logo contains a stylized letter "Z" inside of a circle.
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized eagle with its wings spread.
JAN 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laura D. Williams, RAC Manager, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581
Re: K043560
Trade/Device Name: Zimmer® Periarticular Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: December 23, 2004 Received: December 27, 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.
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Page 2 - Ms. Laura D. Williams, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegill maneting of substantial equivalence of your device to a legally prematics noticate 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 If you desire specific at 1240) 276-0115. Also, please note the regulation entitled, eonidor the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general intermation on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark A. Melleuson
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 .
- Malunions .
Mark A. Milkerer
Division of General, Restorative, and Neurological Devices
510(k) Number K043560
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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