(80 days)
Not Found
No
The summary describes a mechanical device (screws for bone fixation) and includes standard performance testing for such devices (sterilization, shelf life, biocompatibility, mechanical strength). There is no mention of image processing, AI, ML, or any data-driven algorithms.
No
The device is a temporary internal fixation device designed for stabilizing fractures during healing, which is a supportive role rather than active therapeutic intervention.
No
Explanation: The device description states its purpose is to "stabilize fractures during the normal healing process," indicating a therapeutic rather than a diagnostic function. There is no mention of it being used for detecting, identifying, or monitoring medical conditions.
No
The device description and performance studies clearly indicate a physical, implantable device (screws) used for internal fixation, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to "stabilize fractures during the normal healing process." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description reinforces the therapeutic nature of the device as a "temporary internal fixation device."
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information about a patient's health status, which are key characteristics of IVDs.
- Performance Studies: The performance studies focus on the physical and material properties of the device (sterilization, shelf life, biocompatibility, mechanical strength), not on diagnostic accuracy or clinical outcomes related to diagnosis.
IVDs are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device is used to treat a condition (fractures) by providing stabilization.
N/A
Intended Use / Indications for Use
Temporary internal fixation devices are designed to stabilize fractures during the normal healing process.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN
Device Description
Temporary internal fixation devices, such as the ZPS screws, are designed to stabilize fractures during the normal healing process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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:
- Sterilization Validation - To demonstrate that at a minimum gamma dose of 20kGy the devices can be terminally sterilized to a SAL of 10to or better.
- Shelf Life - Accelerated aging showed that the product has a shelf life of 10 years.
- Sterile Packaging - To withstand normal distribution and storage conditions and maintain the sterile barrier properties throughout the specified product shelf life.
- Biocompatibility - Biocompatibility testing on the screw material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
Providing these screws pre-sterilized did not change the intended use or the fundamental scientific technology of any of the devices. Each sterile device uses the same operating principle and incorporates the same basic labeling.
The results of either engineering evaluations and/or nonclinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.
Engineering evaluations included any differences between screw diameters, partial thread vs. full threads, starting load, material strength and the differences between the drive types. Screw testing/analysis performed included: cross-sectional analysis, fatigue failure, insertion torque and torque to failure.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
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.
Synthes 1.5mm Mini Fragment LCP System (K090047), Synthes Ti Alloy 2.0mm Cortex Screw (K952272), Zimmer Universal Locking System (K063303, K060710, K082527), Synthes 6.5mm Cancellous Screws (K061621), Pioneer Cannulated Screw System (washer - K003496) and DePuy ACE Composite Locking Nut (K983265)
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
§ 888.3040 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.
0
Image /page/0/Picture/0 description: The image shows the text "K112885 (pg 1/2)" in black font. The text appears to be handwritten. The text likely represents a document identifier and page number.
Image /page/0/Picture/1 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter Z inside it. Below the circle, the word "zimmer" is written in a bold, sans-serif font.
Sponsor:
Date:
Trade Name:
Common Name:
and References:
Predicate Devices:
Classification Names
Contact Person:
DEC 1 9 2011
P.O. Box 708 Warsaw. IN 46581-0708 574 267-6131
510(k) Summary
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs Telephone: (574) 372-4944 Fax: (574) 371-8760
December 19, 2011
Zimmer® Plates and Screws System (ZPS) - Screws only
Temporary Internal Fixation Devices
Single/multiple component metallic bone fixation appliances and accessories - 21 CFR 888.3030, Smooth or threaded metallic bone fixation fastener - 21 CFR 888.3040
Synthes 1.5mm Mini Fragment LCP System (K090047), Synthes Ti Alloy 2.0mm Cortex Screw (K952272), Zimmer Universal Locking System (K063303, K060710, K082527), Synthes 6.5mm Cancellous Screws (K061621), Pioneer Cannulated Screw System (washer - K003496) and DePuy ACE Composite Locking Nut (K983265).
Device Description: Temporary internal fixation devices, such as the ZPS screws, are designed to stabilize fractures during the normal healing process.
Intended Use: Temporary internal fixation devices are designed to stabilize fractures during the normal healing process.
Comparison to Predicate Device: The ZPS Screws are similar in intended use, screw diameter, thread and drive types, and performance characteristics to the predicate devices. The proposed screws are provided sterile vs. non-sterile.
1
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
- . Sterilization Validation - To demonstrate that at a minimum gamma dose of 20kGy the devices can be terminally sterilized to a SAL of 10to or better.
- . Shelf Life - Accelerated aging showed that the product has a shelf life of 10 years.
- . Sterile Packaging - To withstand normal distribution and storage conditions and maintain the sterile barrier properties throughout the specified product shelf life.
- ◆ Biocompatibility - Biocompatibility testing on the screw material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
Providing these screws pre-sterilized did not change the intended use or the fundamental scientific technology of any of the devices. Each sterile device uses the same operating principle and incorporates the same basic labeling.
The results of either engineering evaluations and/or nonclinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.
Engineering evaluations included any differences between screw diameters, partial thread vs. full threads, starting load, material strength and the differences between the drive types. Screw testing/analysis performed included: cross-sectional analysis, fatigue failure, insertion torque and torque to failure.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with outstretched wings. The bird is composed of curved lines that create a sense of movement. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer Inc. % Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, IN 46581-0708
DEC 1 9 2011
Re: K112885
Trade/Device Name: Zimmer® Plates and Screws System (ZPS) – Screws Only Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: September 29, 2011 Received: September 30, 2011
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 r trade of a rised 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 or uny 1 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 Of ICP and 607), lacemig (21 CFR 803); good manufacturing practice requirements as set
3
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Erin Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K 112885 (pg 1/1)
Device Name:
Zimmer 9 Plates and Screws System (ZPS) - Screws only
Indications for Use:
Temporary internal fixation devices are designed to stabilize fractures during the normal healing process.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
್ಕೆ ಮಾಡಿ
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for March Mekkuser
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112885