(36 days)
Not Found
No
The document 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 osteotomies and fractures, which are therapeutic interventions.
No
Explanation: The device description states it is a "plate and screw system intended for internal fracture fixation." Its intended use is for temporary internal fixation and stabilization of osteotomies and fractures. It is a tool for treatment, not for diagnosing a condition.
No
The device description explicitly states it is a "plate and screw system intended for internal fracture fixation," which are physical hardware components.
Based on the provided information, 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 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: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
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 .
- Malunions .
Product codes
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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.
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Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter "Z" inside it, followed by the word "zimmer" in a bold, sans-serif font. The letter "Z" is black, and the word "zimmer" is also black.
| OCT 2 9 2004 | Summary of Safety and Effectiveness | |
|---|---|---|
| Submitter: | Zimmer, Inc. | |
| P.O. Box 708 | ||
| Warsaw, IN 46581-0708 | ||
| Contact Person: | Noah J. Bartsch, MS | |
| Specialist, Corporate Regulatory Affairs | ||
| Telephone: (574) 371-8552 | ||
| Fax: (574) 372-4605 | ||
| Date: | September 22, 2004 | |
| Trade Name: | Zimmer® Periarticular Locking Plates | |
| Classification Name: | Plate, Fixation, Bone | |
| Screw, Fixation, Bone | ||
| Classification Reference: | 21 CFR § 888.3030,3040 | |
| Predicate Devices: | Zimmer® Periarticular Locking Plate System | |
| K040593, cleared April 12, 2004 | ||
| Synthes Locking Condylar Plate (LCP) System – | ||
| 4.5mm LCP Condylar Plate, K000066, cleared | ||
| March 15, 2000 | ||
| Zimmer® ECT® Internal Fracture Fixation System, | ||
| Preamendments Device | ||
| Synthes LCP System - 3.5/4.5mm LCP | ||
| Metaphyseal Plate System, K033805, cleared | ||
| February 20, 2004 | ||
| Zimmer® Magna-Fx® Cannulated Screw Fixation | ||
| System, Preamendments Device | ||
| 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 | ||
| 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. | ||
| Comparison to Predicate Devices: | 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/1/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a stylized letter "Z" inside of a circle, followed by the word "zimmer" in lowercase letters. The letter "Z" and the word "zimmer" are both in a bold, sans-serif font.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged 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
OCT 2 9 2004
Mr. Noah J. Bartsch, MS Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581
Re: K042598
Trade/Device Name: Zimmer® Periarticular Locking System Regulation Number: 21 CFR 888.3030, 21 CFR 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HRS, HWC Dated: September 22, 2004 Received: September 23, 2004
Dear Mr. Bartsch:
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
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Page 2 - Mr. Noah J. Bartsch, MS
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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) 276-0120. 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 vours.
sincerely, yours,
L. Mark X. Mellum
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
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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 .
L. Mark A. Mchuson
Division of General, Restorative, and Neurological Devices
510(k) Number K042598
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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