(37 days)
Not Found
No
The summary describes standard surgical implants (plates and screws) for fracture fixation and does not mention any AI/ML components or functionalities.
Yes
The device, consisting of plates and screws, is intended for "temporary internal fixation and stabilization of fractures and osteotomies," which are medical conditions, and helps in the "normal healing process," thus providing a therapeutic benefit.
No
Explanation: The device is indicated for internal fixation and stabilization of fractures and osteotomies, which are therapeutic interventions, not diagnostic ones.
No
The device description explicitly states that the system consists of temporary implants (plates and screws) and instrumentation, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for "temporary internal fixation and stabilization of fractures and osteotomies of the distal radius" and "complex extra-articular fractures and osteotomies of the calcaneus." This describes a surgical implant used within the body to treat bone fractures.
- Device Description: The description confirms the devices are "temporary implants (plates and screws)" for managing "periarticular bone fractures." Again, this points to a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, which is the defining characteristic of an IVD. The text does not describe any diagnostic function or analysis of biological samples.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Periarticular Plating System Small Distal Volar Radial Radius and Small Distal Volar Ulnar Radius plates are indicated for temporary internal fixation and stabilization of fractures and osteotomies of the distal radius, including associated carpal fusions.
Periarticular Plating System Calcaneal plates are indicated for complex extra-articular fractures and osteotomies of the calcaneus.
Periarticular Plating System screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Zimmer Periarticular Plating System consists of temporary implants (plates and screws) and instrumentation for the management of periarticular bone fractures through interfragmentary compression and bone plating. Bone screws are provided for use with or without bone plates for fractures. This submission covers non-sterile versions of previously cleared sterile Zimmer Periarticular Plating System screws and various sizes of the following sterile plates: Distal Volar Radial Radius, Distal Volar Ulnar Radius, Lateral Calcaneal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius, calcaneus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 – Engineering analysis demonstrates the devices are safe and effective and substantially equivalent to the predicate devices.
Conclusions: The non-clinical performance data presented in this submission show 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.
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.
Zimmer Periarticular Plating System Screws (K111447), Synthes Distal Radius Plate System (K982732), Synthes Calcaneal Plate (K020401)
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.
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Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized 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
October 22, 2014
Zimmer, Incorporated Mr. Stephen H. McKelvey, MA, RAC Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K142579
Trade/Device Name: Zimmer® Periarticular 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: September 12, 2014 Received: September 15, 2014
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. Iisting 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
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Page 2 - Mr. Stephen H. McKelvey
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
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 yours,
Lori A. Wiggins -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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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 Plating System
Indications for Use (Describe)
Periarticular Plating System Small Distal Volar Radial Radius and Small Distal Volar Ulnar Radius plates are indicated for temporary internal fixation and stabilization of fractures and osteotomies of the distal radius, including associated carpal fusions.
Periarticular Plating System Calcaneal plates are indicated for complex extra-articular fractures and osteotomies of the calcaneus.
Periarticular Plating System screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.
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 features a stylized blue letter "Z" inside of a blue circle. Below the circle is the word "zimmer" in lowercase blue 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) 372-4605 |
| Date: | September 12, 2014 |
| Trade Name: | Zimmer® Periarticular Plating System |
| Common Name: | Periarticular Non-locking Plates and Screws |
| Classification Names
and References: | Single/Multiple Component Metallic Bone Fixation
Appliances and Accessories, 21 CFR 888.3030 (HRS);
Smooth or Threaded Metallic Bone Fixation Fastener 21
CFR 888.3040 (HWC) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Zimmer Periarticular Plating System Screws (K111447)
Synthes Distal Radius Plate System (K982732)
Synthes Calcaneal Plate (K020401) |
| Purpose and Device
Description: | The Zimmer Periarticular Plating System consists of
temporary implants (plates and screws) and
instrumentation for the management of periarticular bone
fractures through interfragmentary compression and bone
plating. Bone screws are provided for use with or without
bone plates for fractures. This submission covers non-
sterile versions of previously cleared sterile Zimmer
Periarticular Plating System screws and various sizes of
the following sterile plates: Distal Volar Radial Radius,
Distal Volar Ulnar Radius, Lateral Calcaneal. |
4
| Intended Use: | Small Distal Volar Radial Radius and Small Distal Volar
Ulnar Radius plates are indicated for temporary internal
fixation and stabilization of fractures and osteotomies of
the volar aspect of the distal radius, including associated
carpal fusions. Calcaneal plates are indicated for complex
extra-articular and intra-articular fractures and osteotomies
of the calcaneus. Screws are temporary internal fixation
devices designed to stabilize fractures during the normal
healing process. |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate Device: | The Zimmer Periarticular Plating System plates and
screws covered by this submission are substantially
equivalent to the predicate devices, in that they have the
same intended use, function, and fundamental scientific
technology. The differences between the subject and
predicate devices do not raise new issues of safety or
effectiveness. |
| 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 – Engineering analysis
demonstrates the devices are safe and effective and
substantially equivalent to the predicate devices. |
| | Conclusions: The non-clinical performance data presented
in this submission show 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. |