(134 days)
Not Found
No
The summary describes a mechanical fixation device (screws) and focuses on material properties, sterilization, shelf life, and mechanical performance testing. There is no mention of AI/ML, image processing, or data-driven algorithms.
Yes
The device is described as a "temporary internal fixation device" designed to "stabilize fractures during the normal healing process," which directly implies a therapeutic function by aiding the body's recovery.
No
The device is described as "Temporary internal fixation devices" and its purpose is "to stabilize fractures during the normal healing process," which indicates a therapeutic or supportive function rather than a diagnostic one.
No
The device description and performance studies clearly indicate this is a physical medical device (screws for internal fixation) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Temporary internal fixation devices are designed to stabilize fractures during the normal healing process." This describes a device used within the body to support bone healing, not a test performed outside the body on samples to diagnose or monitor a condition.
- Device Description: The description focuses on the physical characteristics and materials of screws used for internal fixation.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Using reagents or assays
The device described is a surgical implant used for orthopedic purposes.
N/A
Intended Use / Indications for Use
Temporary internal fixation devices are designed to stabilize fractures during the normal healing process.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Zimmer® Periarticular Plating System - Screws are similar in intended use, type of materials, and performance characteristics to the predicate devices (Zimmer Periarticular Locking Plate System - K042598, cleared 10/29/2004). The proposed screws are provided sterile vs. non-sterile.
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)
Non-Clinical Performance and Conclusions:
- . Sterilization Validation - To demonstrate that at a minimum gamma dose of 20kGy the devices can be terminally sterilized to a SAL greater than or equal to 10-6.
- . Shelf Life - Accelerated aging showed that the product has a shelf life of 10 years.
- . Sterile Packaging - To withstand normal distribution and storage conditions and maintain the sterile barrier properties throughout the specified product shelf life.
- . Biocompatibility - Biocompatibility testing on the screw material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
Providing these screws pre-sterilized did not change the intended use or the fundamental scientific technology of any of the devices. Each sterile device uses the same operating principle and incorporates the same basic labeling.
The results of either engineering evaluations and/or nonclinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.
Engineering evaluations included any differences between screw diameters, partial thread vs. full threads, starting load, bending or fatigue failure, material strength and the elimination of locking threads on the drive heads. Screw testing/analysis performed included: cross-sectional analysis, fatigue failure, insertion torque and torque to failure.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
KIII447(1/2)
Image /page/0/Picture/1 description: The image shows the date "OCT - 5 2011". The month is October, the day is the 5th, and the year is 2011. The text is in a simple, sans-serif font and is horizontally aligned.
P.O. Box 708 Warsaw. IN 46581-0708 574 267-6131
Image /page/0/Picture/3 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter Z inside of it. Below the circle is the word "zimmer" in a lowercase, sans-serif font.
510(k) Summary
Warsaw. IN 46581-0708
Zimmer, Inc.
P.O. Box 708
August 22, 2011
CFR 888.3040
non-sterile.
Sponsor:
Contact Person:
Stephen H. McKelvey Senior Project Manager. Trauma Regulatory Affairs Telephone: (574) 372-4944 Fax: (574) 371-8760
Zimmer® Periarticular Plating System - Screws
Zimmer Periarticular Locking Plate System
Smooth or threaded metallic bone fixation fastener - 21
Temporary internal fixation devices are designed to stabilize fractures during the normal healing process.
Temporary internal fixation devices are designed to stabilize fractures during the normal healing process.
The Zimmer® Periarticular Plating System - Screws are
Periarticular Locking Plate System - K042598, cleared 10/29/2004). The proposed screws are provided sterile vs.
characteristics to the predicate devices (Zimmer
Non-Clinical Performance and Conclusions:
similar in intended use, type of materials, and performance
Temporary Internal Fixation Devices
Date:
Trade Name:
Common Name:
Classification Names and References:
Predicate Devices:
Device Description:
Intended Use:
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
- . Sterilization Validation - To demonstrate that at a minimum gamma dose of 20kGy the devices can be terminally sterilized to a SAL greater than or equal to 10-6.
1
KI11447 (2/2
- . Shelf Life - Accelerated aging showed that the product has a shelf life of 10 years.
- . Sterile Packaging - To withstand normal distribution and storage conditions and maintain the sterile barrier properties throughout the specified product shelf life.
- . Biocompatibility - Biocompatibility testing on the screw material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
Providing these screws pre-sterilized did not change the intended use or the fundamental scientific technology of any of the devices. Each sterile device uses the same operating principle and incorporates the same basic labeling.
The results of either engineering evaluations and/or nonclinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.
Engineering evaluations included any differences between screw diameters, partial thread vs. full threads, starting load, bending or fatigue failure, material strength and the elimination of locking threads on the drive heads. Screw testing/analysis performed included: cross-sectional analysis, fatigue failure, insertion torque and torque to failure.
In summary, the sterile devices described in this submission are substantially equivalent to their predicates.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The eagle is facing to the right. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer. Inc. % Mr. Stephen McKelvey Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
OCT - 5 2011
Re: K111447
Trade/Device Name: Zimmer® Periarticular Plating System - Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 22, 2011 Received: August 23, 2011
Dear Mr. McKelvey:
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 (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Mr. Stephen McKelvey
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Safetv/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/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,
Mark N. Melkers Director
Division of Surgical. Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K1|||447
Device Name:
Zimmer® Periarticular Plating System - Screws
Indications for Use:
Temporary internal fixation devices are designed to stabilize fractures during the normal healing process.
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)
Michael Alves to MX
(Division Sign-Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111947