(167 days)
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.
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.
The provided document describes the Zimmer Plates and Screws System (ZPS) - Non-Sterile Plates and Screws (K140508). This is a medical device, and the submission focuses on demonstrating its substantial equivalence to predicate devices rather than proving its performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication, and reader studies is not explicitly available in this type of regulatory submission.
However, based on the "Performance Data (Nonclinical and/or Clinical)" section, we can infer some aspects of what served as "acceptance criteria" for the non-clinical testing performed.
Here's an attempt to answer your questions based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a non-clinical evaluation for substantial equivalence, the "acceptance criteria" are implied by the comparison to predicate devices and recognized standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet requirements of ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). | 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 (Plates): Demonstrate comparable or superior strength to predicate devices (e.g., via four-point bend testing / beam bending cross-sectional analysis). | Four-point bend testing and/or 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. |
| Performance (Screws): Equivalency to previously cleared sterile ZPS screws (K112885). | The non-sterile ZPS screws are identical to the sterile ZPS screws cleared under K112885. 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. This implies their performance is accepted as equivalent to the predicate sterile screws, which were presumably cleared based on their own performance data. |
| Material: Identical or substantially equivalent materials to predicate devices. | "The ZPS Plates/Screws are similar in intended use, basic shape, compatible screw diameters, materials and performance characteristics to the predicate devices." (Implied acceptance is material equivalency to predicate). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size:
- Biocompatibility: The document states "Biocompatibility testing... was conducted." It does not specify the number of samples or animal subjects used, as is common for a summary of this type.
- Performance (Plates): The document refers to "four point bend testing and/or the beam bending cross sectional analysis." It does not specify the number of plates tested.
- Performance (Screws): No new testing was performed for the screws, as they were deemed identical to a previously cleared device.
- Data Provenance: Not specified in the provided text, but non-clinical testing is typically conducted in a laboratory setting. This is not clinical data; it's laboratory performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a bone fixation system (plates and screws), not a diagnostic algorithm or imaging device where "ground truth" would be established by experts. The "ground truth" for non-clinical performance refers to the actual physical properties and behavior of the device under testing conditions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring expert adjudication of results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance data, the "ground truth" would be:
- Biocompatibility: Standardized assay results compared against pass/fail criteria per ISO 10993-1.
- Performance (Plates): Measured mechanical properties (e.g., strength, stiffness) obtained from standardized test methods such as four-point bend testing, compared against predicate device performance.
8. The sample size for the training set
Not applicable. This is not a device employing machine learning or AI that would require a "training set."
9. How the ground truth for the training set was established
Not applicable.
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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
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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
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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 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Stephen H. McKelveySenior Project Manager, Trauma Regulatory AffairsTelephone: (574) 372-4944Fax: (574) 371-8760 |
| Date: | August 12, 2014 |
| Trade Name: | Zimmer® Plates and Screws System (ZPS) – Non-SterilePlates and Screws |
| Common Name: | Temporary Internal Fixation Devices |
| Classification Namesand References: | Single/multiple component metallic bone fixationappliances and accessories (21 CFR 888.3030) and Smoothor threaded metallic bone fixation fastener (21 CFR888.3040) |
| Classification Panel: | Orthopedics/87, Product codes HRS, HWC, HTN |
| Predicate Devices: | Sterile Zimmer Plates and Screws System (ZPS) - Screwsonly (K112885), TMP Microplating System (K921458),Zimmer Universal Locking System 3.5mm Locking Platesand Screws (K060710) and Zimmer Universal LockingSystem 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. Plateshapes vary to address varying patient bone sizes and injuryfragment sizes. Plates incorporate a spherical sliding slopeplate hole design to achieve the compression required totreat bone fractures. The plates are used with a variety ofscrews for temporary fixation to the bone. |
| Intended Use: | ZPS One-Third Tubular Plates, T-Plates and Semi-Tubularplates are indicated for temporary internal fixation andstabilization of osteotomies and fractures, such as: |
| • comminuted fractures• supracondylar fractures• extra-articular fractures• fractures in osteopenic bone• nonunions• malunionsSmaller-sized ZPS plates are used for small bones andsmall fragments of the hands and feet.ZPS Screws are temporary internal fixation devicesdesigned to stabilize fractures during the normal healingprocess. | |
| Comparison to Predicate Device: | The ZPS Plates/Screws are similar in intended use, basicshape, compatible screw diameters, materials andperformance characteristics to the predicate devices. Thesubject devices are provided non-sterile. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions:• Biocompatibility - Biocompatibility testing on theplate and screw material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). Alltesting passed.• Performance Testing - The four point bend testingand/or the beam bending cross sectional analysisconducted on both the subject non-sterile ZPS platesand their respective predicate devices demonstratedthat, in all cases, the subject ZPS plates were superior instrength.Because the non-sterile ZPS screws are identical to thesterile ZPS screws cleared under K112885 and becausethe sterilization status for these metal devices does notaffect the performance testing, no additional testingbeyond the data included in K112885 was required.Clinical Performance and Conclusions:Clinical data and conclusions were not needed for thesedevices. |
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§ 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.