(35 days)
Not Found
No
The document describes a system of mechanical plates and screws for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
Explanation: The device, a plate and screw system, is indicated for temporary internal fixation and stabilization of fractures, which falls under the definition of a therapeutic device.
No
Explanation: The device is a system of plates and screws used for temporary internal fixation and stabilization of osteotomies and fractures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "nonlocking, stainless steel plate and screw system," 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 that the ZPS system is for "temporary internal fixation and stabilization of osteotomies and fractures." This is a surgical procedure performed in vivo (within the body) to physically stabilize bone.
- Device Description: The description details a system of plates, screws, and washers made of stainless steel, designed for mechanical support of bone. This is consistent with a surgical implant, not a diagnostic test performed in vitro (outside the body).
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status through laboratory testing.
- Performance Studies: The performance studies focus on biocompatibility and mechanical properties, which are relevant to surgical implants, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, T-Plates, Cobra Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, and Contourable Dual Compression Plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:
- · comminuted fractures
- · supracondylar fractures
- · extra-articular fractures
- · fractures in osteopenic bone
- nonunions
• malunions
Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet.
ZPS Calcaneal plates are indicated for temporary internal fixation of osteotomies and fractures of the calcaneus. ZPS and Forte Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process
Product codes
HRS, HTN, HWC
Device Description
The Zimmer Plates and Screws System (ZPS) is a nonlocking, stainless steel plate and screw system. Plate shapes vary to address varying patient bone sizes and injury fragment sizes. Plates incorporate a spherical sliding slope plate hole design to achieve the compression required to treat bone fractures. The plates are used with a variety of screws for temporary fixation to the bone. The ZPS Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a larger area when used for non-plate, bone fragment, and fracture fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones, hands, feet, calcaneus
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:
- Biocompatibility - Biocompatibility testing on the plate, screw, and washer material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
- Beam bending cross sectional analysis of the ZPS Plates and the predicate devices, Zimmer Plate and Screw System (K140508) and the TMP Micro-Plating System (K921458), resulted in similar mechanical properties. The subject and predicate devices are substantially equivalent.
- The subject screws are substantially equivalent to those cleared in K140508 and are a line extension to screw types already cleared in K140508.
- The subject washers are substantially equivalent to and are a line extension to the washer cleared in K140508.
Clinical Performance and Conclusions: - Clinical data and conclusions were not needed for these devices.
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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 28, 2014
Zimmer. Inc. Stephen H. McKelvey, MA. RAC Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K143066
Trade/Device Name: Zimmer® Plates and Screws System (ZPS) - Non-sterile ZPS Plate Line Extensions, Sterile/Non-sterile ZPS Screws and Washers Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS, HTN, HWC Dated: October 23, 2014 Received: October 31, 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, 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
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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS Plate Line Exterile ZPS Screws and Washers
Indications for Use (Describe)
ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, T-Plates, Cobra Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, and Contourable Dual Compression Plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:
- · comminuted fractures
- · supracondylar fractures
- · extra-articular fractures
- · fractures in osteopenic bone
- nonunions
• malunions
Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet.
ZPS Calcaneal plates are indicated for temporary internal fixation of osteotomies and fractures of the calcaneus. ZPS and Forte 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 features the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized letter "Z" inside it. Below the circle, the word "zimmer" is written in lowercase letters, also in blue.
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: | October 23, 2014 |
| Trade Name: | Zimmer® Plates and Screws System (ZPS) – Non-Sterile
ZPS Plate Line Extensions, Sterile/Non-Sterile ZPS
Screws and Washers |
| Common Name: | Temporary Internal Fixation Devices |
| Classification Names
and References: | Single/multiple component metallic bone fixation
appliances and accessories (21 CFR 888.3030, HRS and
HTN) and Smooth or threaded metallic bone fixation
fastener (21 CFR 888.3040, HWC) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Zimmer Plates and Screws System (ZPS) (K140508,
cleared August 14, 2014)
TMP Micro-plating System (Anspach/Techmedica,
K921458, cleared July 17, 1992) |
| Purpose and Device Description: | The Zimmer Plates and Screws System (ZPS) is a
nonlocking, stainless steel plate and screw system. Plate
shapes vary to address varying patient bone sizes and
injury fragment sizes. Plates incorporate a spherical
sliding slope plate hole design to achieve the compression
required to treat bone fractures. The plates are used with a
variety of screws for temporary fixation to the bone. The
ZPS Washers are intended to prevent a screw head from
breaking through the cortex of the bone by distributing the |
4
| Intended Use: | forces/load over a larger area when used for non-plate, bone fragment, and fracture fixation. |
|---|---|
| ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, T-Plates, L-Buttress Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, and Contourable Dual Compression Plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as: | |
| comminuted fracturessupracondylar fracturesextra-articular fracturesfractures in osteopenic bonenonunionsmalunions | |
| Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet. | |
| ZPS Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneus. ZPS and Forte Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process. | |
| Comparison to Predicate Device: | The ZPS Plates, Screws and Washers are similar in intended use, basic shape, compatible diameters, materials and performance characteristics to the predicate devices. |
| Performance Data (Nonclinical and/or Clinical): | Non-Clinical Performance and Conclusions: |
| Biocompatibility - Biocompatibility testing on the plate, screw, and washer material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.Beam bending cross sectional analysis of the ZPS Plates and the predicate devices, Zimmer Plate and Screw System (K140508) and the TMP Micro-Plating System (K921458), resulted in similar mechanical properties. The subject and predicate devices are substantially equivalent.The subject screws are substantially equivalent to those cleared in K140508 and are a line extension to screw types already cleared in K140508. |
5
-
The subject washers are substantially equivalent to and . are a line extension to the washer cleared in K140508.
Clinical Performance and Conclusions: -
Clinical data and conclusions were not needed for . these devices.