(47 days)
Not Found
No
The summary describes a mechanical plate and screw system for fracture fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is indicated for "temporary internal fixation of osteotomies and fractures," which inherently refers to the treatment of a medical condition.
No
Explanation: The device is described as a "plate and screw system intended for internal fracture fixation," which is a treatment modality, not a diagnostic one.
No
The device description explicitly 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 of osteotomies and fractures." This describes a surgical implant used to stabilize bones, 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 is consistent with a surgical implant, not an IVD.
- 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 those samples
- Providing information for diagnosis, monitoring, or screening
The Zimmer Periarticular Locking Plate System is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Zimmer Periarticular Locking Plate System is indicated for temporary intemal fixation of osteotomies and fractures, including:
- Comminuted fractures
- Supracondylar fractures
- Intra-articular and extra-articular condylar fractures
- Fractures in osteopenic bone
- Nonunions
- Malunions
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
This submission covers minor design modifications and line extensions of the Zimmer Periarticular Locking Plate System. The Zimmer Periarticular Locking Plate System is a plate and screw system intended for internal fracture fixation. The low-profile locking plates are anatomically contoured and have threaded holes that 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)
Non-Clinical Performance and Conclusions:
- Shelf Life - Accelerated aging testing conducted shows that the sterile devices included in this submission have a shelf life of 10 years.
- Biocompatibility - Biocompatibility testing of the subject devices was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.
- Performance Testing - Testing performed included engineering analysis, as well as dynamic/fatigue construct testing, evaluation of screw torsional failure strength, driving torque, and axial pull out strength.
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 for these devices 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 13, 2014
Zimmer. Inc. Stephen H. McKelvey, MA. RAC Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K141734 Trade/Device Name: Zimmer® Periarticular Locking Plate 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: June 26, 2014 Received: June 27, 2014
Dear Mr. Stephen H. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. Stephen H. McKelvey
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 contact the Division of Industry and Consumer Education 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. 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/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Zimmer Periarticular Locking Plate System
| Indications for Use (Describe) | |
|---|---|
| --------------------------------------- | -- |
The Zimmer Periarticular Locking Plate System is indicated for temporary internal fixation of osteotomies and fractures, including:
- Comminuted fractures
- Supracondylar fractures
- Intra-articular and extra-articular condylar fractures
- Fractures in osteopenic bone
- Nonunions
- Malunions
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside it. Below the circle, the word "zimmer" is written in blue lowercase letters.
510(k) Summary
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen H. McKelvey
Senior Project Manager, Trauma Regulatory Affairs
Telephone: (574) 372-4944
Fax: (574) 371-8760 |
| Date: | June 26, 2014 |
| Trade Name: | Zimmer® Periarticular Locking Plate System |
| Common Name: | Periarticular Locking Plates and Screws |
| Classification Names
and References: | Single/Multiple Component Metallic Bone Fixation
Appliances and Accessories (21 CFR 888.3030); Smooth
or Threaded Metallic Bone Fixation Fastener (21 CFR
888.3040) |
| Classification Panel: | Orthopedics/87, Product codes HRS, HWC |
| Predicate Device(s): | Zimmer Periarticular Locking Plate System
(K042598, K082078, K111039) |
| Purpose and Device
Description: | This submission covers minor design modifications and
line extensions of the Zimmer Periarticular Locking Plate
System. The Zimmer Periarticular Locking Plate System
is a plate and screw system intended for internal fracture
fixation. The low-profile locking plates are anatomically
contoured and have threaded holes that 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 |
4
| Comparison to Predicate Device: | The Zimmer Periarticular Locking Plate System plates and
screws covered by this submission are similar in intended
use, design, compatible screw diameters, materials, and
performance characteristics to the predicate devices. |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions: |
- . Shelf Life - Accelerated aging testing conducted shows that the sterile devices included in this submission have a shelf life of 10 years.
- . Biocompatibility - Biocompatibility testing of the subject devices was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.
- . Performance Testing - Testing performed included engineering analysis, as well as dynamic/fatigue construct testing, evaluation of screw torsional failure strength, driving torque, and axial pull out strength.
The results of non-clinical performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.
Conclusions: The non-clinical performance data presented in this submission show that the changes do not affect the safety and/or effectiveness of the subject devices and that the subject devices will perform in a substantially equivalent manner to the predicate devices.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for these devices to show substantial equivalence.