(167 days)
Not Found
No
The summary describes a mechanical plate and screw system for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is designed to stabilize fractures and assist in the healing process of bones, which is a therapeutic function.
No
The device description clearly states its purpose: "ZPS One-Third Tubular Plates, T-Plates and Semi-Tubular plates are indication and stabilization of osteotomies and fractures," and "ZPS Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process." This indicates it is a therapeutic device, not a diagnostic one.
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 the "indication and stabilization of osteotomies and fractures." This describes a surgical implant used to physically support and fix bone during healing.
- Device Description: The description details a "non-locking, stainless steel plate and screw system" designed for "temporary internal fixation." This aligns with the description of a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings for testing purposes.
The device is a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
ZPS One-Third Tubular Plates, T-Plates and Semi-Tubular plates are indication 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 Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.
Product codes
HRS, HWC, HTN
Device Description
The Zimmer Plates and Screws System (ZPS) 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, hands and feet
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 and screw material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
• Performance Testing - The four point bend testing and/or the beam bending cross sectional analysis conducted on both the subject non-sterile ZPS plates and their respective predicate devices demonstrated that, in all cases, the subject ZPS plates were superior in strength.
Because the non-sterile ZPS screws are identical to the sterile ZPS screws cleared under K112885 and because the sterilization status for these metal devices does not affect the performance testing, no additional testing beyond the data included in K112885 was required.
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)
K112885, K921458, K060710, K063303
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 shows the logo for the U.S. Department of Health and 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, stacked on top of each other.
August 14, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Zimmer. Inc. Mr. Stephen H. McKelvev. MA. RAC Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K140508 Trade/Device Name: Zimmer® Plates and Screws System (ZPS) - Non-Sterile Plates and Screws 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: June 19, 2014 Received: June 20, 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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
Page 2 - Mr. Stephen H. 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 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" (21 CFR 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
Indications for Use
510(k) Number (if known)
K140508
Device Name
Zimmer Plates and Screws System (ZPS) - Non-Sterile Plates and Screws
Indications for Use (Describe)
ZPS One-Third Tubular Plates, T-Plates and Semi-Tubular plates are indication 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 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)
Expiration Date: January 31, 2017
See PRA Statement on last page.
Pg. 1/1
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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a blue letter Z inside of a blue circle. Below the circle is the word "zimmer" in a lowercase, sans-serif font, 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: | August 12, 2014 |
| Trade Name: | Zimmer® Plates and Screws System (ZPS) – Non-Sterile
Plates and Screws |
| Common Name: | Temporary Internal Fixation Devices |
| Classification Names
and References: | Single/multiple component metallic bone fixation
appliances and accessories (21 CFR 888.3030) and Smooth
or threaded metallic bone fixation fastener (21 CFR
888.3040) |
| Classification Panel: | Orthopedics/87, Product codes HRS, HWC, HTN |
| Predicate Devices: | Sterile Zimmer Plates and Screws System (ZPS) - Screws
only (K112885), TMP Microplating System (K921458),
Zimmer Universal Locking System 3.5mm Locking Plates
and Screws (K060710) and Zimmer Universal Locking
System 2.7mm Locking Plates and Screws (K063303). |
| Purpose and Device Description: | The Zimmer Plates and Screws System (ZPS) 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. |
| Intended Use: | ZPS One-Third Tubular Plates, T-Plates and Semi-Tubular
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 Screws are temporary internal fixation devices
designed to stabilize fractures during the normal healing
process. | |
| Comparison to Predicate Device: | The ZPS Plates/Screws are similar in intended use, basic
shape, compatible screw diameters, materials and
performance characteristics to the 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
plate and screw material was conducted per ISO 10993-
1 and Good Laboratory Practices (21 CFR § 58). All
testing passed.
• Performance Testing - The four point bend testing
and/or the beam bending cross sectional analysis
conducted on both the subject non-sterile ZPS plates
and their respective predicate devices demonstrated
that, in all cases, the subject ZPS plates were superior in
strength.
Because the non-sterile ZPS screws are identical to the
sterile ZPS screws cleared under K112885 and because
the sterilization status for these metal devices does not
affect the performance testing, no additional testing
beyond the data included in K112885 was required.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for these
devices. |
4