K Number
K141517
Device Name
ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES
Manufacturer
Date Cleared
2014-08-13

(65 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ZPS Plates are indicated for temporary internal fixation of osteotomies and fractures. 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 Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.
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 ZPS screws for temporary fixation to the bone.
More Information

Not Found

No
The summary describes a mechanical plate and screw system for bone fixation. There is no mention of software, image processing, or any terms related to AI/ML. The performance studies focus on mechanical properties.

Yes
The device is a temporary internal fixation device designed to stabilize fractures during the normal healing process, which directly supports the treatment and healing of injuries, classifying it as therapeutic.

No

Explanation: The device is a surgical implant designed for temporary internal fixation of osteotomies and fractures, not for diagnosing medical conditions.

No

The device description clearly states it is a "non-locking, stainless steel plate and screw system," which are physical hardware components. The performance studies also focus on the mechanical properties of these physical plates and screws.

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 bone, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
  • Device Description: The description details a "non-locking, stainless steel plate and screw system" designed for "temporary fixation to the bone." This is consistent with a surgical implant.
  • 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.)
    • Providing diagnostic information
    • Using reagents or assays
    • Measuring biomarkers

The information provided describes a medical device used for surgical intervention, not for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

ZPS Plates are indicated for temporary internal fixation of osteotomies and fractures. 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 Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.

Product codes

HRS

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 ZPS 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

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. Beam bending cross sectional analysis was conducted on the subject ZPS plates and compared to their respective predicate devices in order to estimate the static and fatigue bending strength. The ZPS plates were grouped based upon their cross-sectional properties. After determining the lowest section modulus (from the cross sectional analysis), the weakest (worst-case) ZPS plate within each of the groups was selected as the representative sample for comparison. The representative ZPS plate sample static and fatigue bending moment calculations were then compared to their respective predicate plate calculations to determine which had the greater bending strength. All calculations used the weakest cross section location of the evaluated plate. In all cases, the subject ZPS plates demonstrated higher static and fatigue bending moments (and greater bending strength) than their respective predicate plates. Each of the evaluated subject ZPS plates met their acceptance criteria for this analysis.

Key Metrics

Not Found

Predicate Device(s)

K921458, K020401

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.

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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 image of three faces in profile, 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: K141517 Trade/Device Name: Zimmer® Plates and Screws System (ZPS) - Non-Sterile Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: June 18, 2014 Received: June 19, 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

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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

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Indications for Use

510(k) Number (if known)

K141517

Device Name

Zimmer Plates and Screws System (ZPS) - Non-Sterile Plates

Indications for Use (Describe)

ZPS Plates are indicated for temporary internal fixation of osteotomies and fractures. 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 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

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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 6, 2014
Trade Name:Zimmer® Plates and Screws System (ZPS) – Non-Sterile Plates
Common Name:Temporary Internal Fixation Devices
Classification Names and References:Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030)
Classification Panel:Orthopedics/87, Product code HRS
Predicate Device(s):TMP Micro-plating System (Anspach/Techmedica, K921458, cleared July 17, 1992) and Synthes Calcaneal Plate (K020401, cleared May 8, 2002).
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 ZPS screws for temporary fixation to the bone.
Intended Use:ZPS Plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures. 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

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of osteotomies and fractures of the calcaneus. ZPS Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process. Comparison to Predicate Device: The ZPS plates are similar in intended use, basic shape, compatible screw hole diameters, materials and performance characteristics to the predicate devices. Performance Data (Nonclinical Non-Clinical Performance and Conclusions: and/or Clinical): . 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. Beam bending cross sectional analysis was conducted ● on the subject ZPS plates and compared to their respective predicate devices in order to estimate the static and fatigue bending strength. The ZPS plates were grouped based upon their cross-sectional properties. After determining the lowest section modulus (from the cross sectional analysis), the weakest (worst-case) ZPS plate within each of the groups was selected as the representative sample for comparison. The representative ZPS plate sample static and fatigue bending moment calculations were then compared to

their respective predicate plate calculations to determine which had the greater bending strength. All calculations used the weakest cross section location of the evaluated plate.

In all cases, the subject ZPS plates demonstrated higher static and fatigue bending moments (and greater bending strength) than their respective predicate plates. Each of the evaluated subject ZPS plates met their acceptance criteria for this analysis.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for these devices.