(56 days)
No
The device description and performance studies focus on the mechanical properties and sterilization of bone plates and screws, with no mention of AI or ML capabilities.
Yes.
The device is indicated for temporary internal fixation and stabilization of osteotomies and fractures, which directly addresses a medical condition (fractures, nonunions, malunions) with a therapeutic action (stabilization and fixation).
No
The device is described as an internal fixation system (plates and screws) used for temporary 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.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being for "temporary internal fixation and stabilization of osteotomies and fractures." This is a surgical procedure performed directly on the patient's bone.
- Device Description: The description details "nonlocking, stainless steel plate and screw system" used for "temporary fixation to the bone." This further reinforces its use in surgical bone repair.
- No mention of in vitro testing: The text does not mention any testing of samples (like blood, urine, tissue) outside of the body. IVDs are designed to perform tests on such samples to provide diagnostic information.
The device described is a surgical implant used for orthopedic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, L-Buttress Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, Contourable Dual Compression Plates, Cloverleaf and Spoon Plates are indicated for temporary internal fixation 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 (comma separated list FDA assigned to the subject device)
HWC
Device Description
The purpose of this submission is a line extension adding the sterile version of the 2.7mm cortical screws cleared under K143066.
System 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:
• Shelf Life - The implants that are supplied sterile have a 10 year shelf life. Zimmer performs shelf life testing based on FDA recognized consensus standards ISO 11607-1:2006 and 11607-2:2006.
• Biocompatibility – Biocompatibility testing on the screw material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.
• Performance Evaluation Because the sterile 2.7mm ZPS screws are identical to the sterile version cleared under K063303 and identical (with exception to sterility) to those non-sterile screws cleared K143066, no additional mechanical testing was performed.
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.
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.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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 that resembles an eagle or a bird in flight, formed by three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 24, 2015
Zimmer, Incorporated Ms. Dorothy Snyder Associate Director, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K152841
Trade/Device Name: Zimmer Plates and Screws System (ZPS) - Sterile 2.7mm Cortical Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 28, 2015 Received: September 29, 2015
Dear Ms. Snyder:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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/ResourcesforYou/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
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
Indications for Use
510(k) Number (if known)
Device Name
Zimmer Plates and Screws System (ZPS) - Sterile 2.7mm Cortical Screws
Indications for Use (Describe)
ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, L-Buttress Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, Contourable Dual Compression Plates, Cloverleaf and Spoon Plates are indicated for temporary internal fixation 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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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:
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"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, the word "zimmer" is written in lowercase, using the same blue color as the "Z" and circle.
510(k) Summary
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dorothy Snyder
Associate Director, Trauma Regulatory Affairs
Telephone: (574) 372-4092
Fax: (574) 372-4605 |
| Date: | November 16, 2015 |
| Trade Name: | Zimmer® Plates and Screws (ZPS) Sterile 2.7mm Cortical
Screw |
| Common Name: | Temporary Internal Fixation Devices |
| Classification Names
and References: | Smooth or threaded metallic bone fixation fastener (21
CFR 888.3040, HWC) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Zimmer® Plates and Screws, Non-sterile 2.7mm cortical
screws cleared under K143066 on November 28, 2014.
Zimmer Plates and Screws System (ZPS) – Non-sterile
ZPS cleared under K143331 on March 04, 2015
Reference Predicate Only:
Universal Locking System, Sterile 2.7mm cortical screws
cleared under K063303 on November 22, 2006. |
| Purpose and Device Description | The purpose of this submission is a line extension adding
the sterile version of the 2.7mm cortical screws cleared
under K143066. |
| | System 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 |
| Intended Use: | ZPS One-Third Tubular Plates, One-Quarter Tubular
Plates, T-Plates, L-Buttress Plates, Cobra 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 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 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 screws are identical in intended use, basic
shape, compatible diameters, materials and performance
characteristics to their respective predicate devices, with
exception that the subject screws will be provided sterile. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions: |
| | • Shelf Life - The implants that are supplied sterile have
a 10 year shelf life. Zimmer performs shelf life testing
based on FDA recognized consensus standards ISO
11607-1:2006 and 11607-2:2006. |
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5
- . Biocompatibility – Biocompatibility testing on the screw material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.
- Performance Evaluation Because the sterile 2.7mm • ZPS screws are identical to the sterile version cleared under K063303 and identical (with exception to sterility) to those non-sterile screws cleared K143066, no additional mechanical testing was performed.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for these devices to show substantial equivalence.