(104 days)
Not Found
No
The summary describes a system of non-locking plates and screws for bone fixation. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on biocompatibility and mechanical performance.
No
The device, a ZPS System, is described as a temporary internal fixation and stabilization device for osteotomies and fractures, designed to stabilize fractures during the normal healing process. Its purpose is mechanical support for anatomical restoration, not to treat or cure a disease or condition.
No
Explanation: The device is described as a system for "temporary internal fixation and stabilization of osteotomies and fractures," which means it is used to treat rather than to diagnose medical conditions.
No
The device description clearly states it is a "non-locking, stainless steel plate and screw system," which are physical hardware components.
Based on the provided information, 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 on the body, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "non-locking, stainless steel plate and screw system" used for "temporary fixation to the bone." This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The ZPS System is a surgical implant used to physically stabilize bones.
N/A
Intended Use / Indications for Use
ZPS One-Third Tubular Plates, T-Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, Contourable Dual Compression Plates, Cloyerleaf and Spoon 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 ostectomies 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 (comma separated list FDA assigned to the subject device)
HRS, HWC, HTN
Device Description
The ZPS System is a non-locking, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones and fragments of the hands and 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 ZPS Plate material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
- Beam bending cross sectional analyses of the ZPS Plates and their respective predicate devices, the ZPS L-Plates, T-Plates, and One-Third Tubular Plates, resulted in similar mechanical performance. The subject and predicate devices are substantially equivalent.
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): 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other.
March 4. 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Zimmer, Incorporated Mr. Stephen H. McKelvev. MA. RAC Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581
Re: K143331 Trade/Device Name: Zimmer Plates and Screws System (ZPS)-Non-sterile ZPS 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, HTN Dated: February 6, 2015 Received: February 9, 2015
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 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 yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
See PRA Statement below.
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
Indications for Use
510(k) Number (if known)
Device Name
Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS
Indications for Use (Describe)
ZPS One-Third Tubular Plates, T-Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, Contourable Dual Compression Plates, Cloyerleaf and Spoon 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 ostectomies 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)
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 large, stylized blue letter "Z" enclosed in a blue circle. Below the circle is the word "zimmer" in a lowercase, sans-serif blue font.
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: | November 19, 2014 |
| Trade Name: | Zimmer Plates and Screws System (ZPS) - Non-sterile
ZPS |
| Common Name: | Temporary Internal Fixation Devices |
| Classification Names
and References: | Single/multiple component metallic bone fixation
appliances and accessories (21 CFR 888.3030, product
codes HRS and HTN) and Smooth or threaded metallic
bone fastener (21 CFR 888.3040, product code HWC) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | ZPS 2.7mm L-Plate, 3.5mm One Third Tubular Plate,
4.5mm T-Plate and 3.5 T Plate, (K140508, cleared August
14, 2014), ZPS 4.5mm T-Plate (K143066, cleared
November 28, 2014), and ZPS 3.5/4.5mm Contourable
Dual Compression Plates (K142836, cleared November
12,2014) |
| Purpose and Device Description: | The ZPS System is a non-locking, 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. |
4
| Indications for Use: | ZPS One-Third Tubular Plates, T-Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, Contourable Dual Compression Plates, Cloverleaf and Spoon 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 subject ZPS Plates are similar in intended use, basic shape, compatible diameters, materials and performance characteristics to their respective predicate devices. The subject devices are provided non-sterile. |
| Performance Data (Nonclinical and/or Clinical): | |
| Non-Clinical Performance and Conclusions: Biocompatibility - Biocompatibility testing on the ZPS Plate material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.Beam bending cross sectional analyses of the ZPS Plates and their respective predicate devices, the ZPS L-Plates, T-Plates, and One-Third Tubular Plates, resulted in similar mechanical performance. The subject and predicate devices are substantially equivalent. | |
| Clinical Performance and Conclusions: Clinical data and conclusions were not needed for |
- . Clinical data and conclusions were not needed for these devices.