(56 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and sterilization of a plate and screw system for bone fixation, with no mention of AI or ML.
No.
The device is a surgical implant (plate and screw system) for internal fixation and stabilization of fractures, which falls under reconstructive or reparative devices rather than therapeutic.
No
The device is a plating system used for surgical fixation, not for diagnosing medical conditions.
No
The device description clearly states it is a "plate and screw system" made from "Ti-6AI-4V ELI alloy," indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "surgical reduction, internal fixation, and stabilization of fractures and osteotomies of the distal radius." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "plate and screw system intended for internal fixation and stabilization of fractures and osteotomies of the distal radius." This is a physical implant used in surgery.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The device is a surgical implant used for orthopedic fixation, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Zimmer Distal Radius Plating System is intended for use in surgical reduction, internal fixation, and stabilization of fractures and osteotomies of the distal radius. Examples of distal radius fractures include but are not limited to compression fractures, intra-articular and extra-articular fractures, displaced fractures in osteopenic bone, non-unions, and malunions.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Zimmer Distal Radius Plating System is a plate and screw system intended for internal fixation and stabilization of fractures and osteotomies of the distal radius. The Zimmer Distal Radius Plating System consists of Volar, Medial and Dorsal locking plates. All the plates have screw holes which can accept either locking or non-locking screws and slots which can accept only non-locking screws. Locking screws and pegs may be inserted at 15° in any direction (30° cone) from the nominal screw hole trajectory. Thus, anatomically contoured plate design combined with locking screw technology creates fixed or variable angled constructs for use in simple or multi-fragment fractures. All the plates and screws are made from Ti-6AI-4V ELI alloy. All the plates and screws are Type II anodized except the nonlocking screws which are color anodized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
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)
Non-clinical performance and conclusions:
-Sterilization Validation: These devices have been validated to demonstrate that at a minimum gamma dose of 20kGy they can be terminally sterilized to a SAL of 10-6 or better.
-Shelf Life: Accelerated aging test conducted shows that the sterile devices included in this submission have a shelf life of 10 years
-Biocompatibility: Biocompatibility testing of the material used to manufacture plates and screws included in this submission was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
-Performance testing: Testing performed included; Dynamic/Fatigue construct testing, evaluating the torsional failure strength, driving torque and axial pull out strength for the Zimmer Distal Radius Plating System screws.
The results of non-clinical performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.
Clinical performance and conclusions:
Clinical data and conclusions were not needed to show substantial equivalence.
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
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Image /page/0/Picture/2 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter "Z" inside it. Below the circle, the word "Zimmer" is written in a font that appears to be outlined.
DEC 1 7 2013
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
510(k) Summary
Sponsor:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Contact Person:
Romil Sheth Specialist, Regulatory Affairs, Zimmer Inc. Telephone: (574) 371 - 1621 Fax: (574) 371 - 8760
Date Summary Prepared:
10/15/2013
Trade Name:
Zimmer Distal Radius Plating System
Common Name:
Classification Name
Locking Plate System
Plate, Fixation, Bone (21 CFR 888.3030); Screw, Fixation, Bone (21 CFR 888.3040)
Product Code:
and Reference:
HRS, HWC
Orthopedic/87
Classification Panel:
Predicate Device(s):
-Stryker® Leibinger Universal Distal Radius System, Stryker, K040022, cleared on March 12th, 2004 - Zimmer® Periarticular Locking Plate System, Zimmer; K040593, cleared on April 12th, 2004
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Purpose and Device Description:
Intended Use:
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
The Zimmer Distal Radius Plating System is a plate and screw system intended for internal fixation and stabilization of fractures and osteotomies of the distal radius. The Zimmer Distal Radius Plating System consists of Volar, Medial and Dorsal locking plates. All the plates have screw holes which can accept either locking or non-locking screws and slots which can accept only non-locking screws. Locking screws and pegs may be inserted at 15° in any direction (30° cone) from the nominal screw hole trajectory. Thus, anatomically contoured plate design combined with locking screw technology creates fixed or variable angled constructs for use in simple or multi-fragment fractures. All the plates and screws are made from Ti-6AI-4V ELI alloy. All the plates and screws are Type II anodized except the nonlocking screws which are color anodized.
The Zimmer Distal Radius Plating System is intended for use in surgical reduction, internal fixation, and stabilization of fractures and osteotomies of the distal radius. Examples of distal radius fractures include but are not limited to compression fractures, intra-articular and extra-articular fractures, displaced fractures, fractures in osteopenic bone, non-unions, and mal-unions.
The Zimmer Distal Radius Plating System is similar in intended use, materials, sterility, and performance characteristics to the predicate devices.
Non-clinical performance and conclusions: -Sterilization Validation: These devices have been validated to demonstrate that at a minimum gamma
dose of 20kGy they can be terminally sterilized to a SAL of 10-6 or better.
2
-Shelf Life: Accelerated aging test conducted shows that the sterile devices included in this submission have a shelf life of 10 years
-Biocompatibility: Biocompatibility testing of the material used to manufacture plates and screws included in this submission was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
-Performance testing: Testing performed included; Dynamic/Fatigue construct testing, evaluating the torsional failure strength, driving torque and axial pull out strength for the Zimmer Distal Radius Plating System screws.
The results of non-clinical performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.
Clinical performance and conclusions:
Clinical data and conclusions were not needed to show substantial equivalence.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol, with its wings forming a protective shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration ... 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
December 17, 2013
Zimmer. Incorporated Mr. Romil Sheth Specialist, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581
Re: K133246
Trade/Device Name: Zimmer Distal Radius Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 21, 2013 Received: October 22, 2013
Dear Mr. Sheth:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 (2) CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Romil Sheth
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.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address. http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ronaldflean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K133246
Device Name:
ﻣﻦ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﻠﻴﻨﻴﺔ
Zimmer Distal Radius Plating System
Indications for Use:
The Zimmer Distal Radius Plating System is intended for use in surgical reduction, internal fixation, and stabilization of fractures and osteotomies of the distal radius. Examples of distal radius fractures include but are not limited to compression fractures, intra-articular and extraarticular fractures, displaced fractures in osteopenic bone, non-unions, and malunions.
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)
Elizabeth L. Frank -S
Division of Orthopedic Devices