(35 days)
Not Found
No
The summary describes a mechanical fixation system for bone fractures and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used for internal fixation of fractures, which falls under the definition of a therapeutic device as it treats a medical condition.
No
This device is a surgical implant designed for internal fixation of fractures, not for diagnosing medical conditions.
No
The device description explicitly states the systems contain "supracondylar tube/plates" and "lag and compression screws," which are physical hardware components used for internal fixation of fractures.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a system of implants (plates and screws) used for the internal fixation of bone fractures in the femur and hip. This is a surgical procedure performed directly on the patient's body, not on a specimen outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
This device is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Versa-Fx Femoral Fixation System may be used for the internal fixation of supracondylar fractures with displaced intra-articular fragments, with verticular extension, and in the patient with multiple lower extremity fractures.
Supracondylar: The Versa-Fx II Femoral Fixation System may be used for the internal fixation of supracondylar fractures with displaced intra-articular fragments, with vertical intra-articular extension, and in the patient with multiple lower extremity fractures.
Proximal Femur: The Versa-Fx II Femoral Fixation System may be used for internal fixation of hip fractures with application to intracapsular and intertrochanteric fractures, arthrodeses, and subtrochanteric fractures with extension into the greater trochanter and the piriformis fossa (Winquist Type III comminuted fracture).
The Free-Lock Femoral Fixation System may be used for internal fixation of hip fractures with application to intracapsular and intertrochanteric fractures, osteotomies, arthrodeses, and subtrochanteric fractures with extension into the greater trochanter and the piriformis fossa (Winquist Type III comminuted fracture).
Product codes (comma separated list FDA assigned to the subject device)
KTT, HRS
Device Description
Zimmer is requesting clearance for modifications to the Versa-Fx, Versa-Fx II and Free-Lock Femoral Fixation Systems. The subject devices are similar in that they are used for either supracondylar or proximal femur fracture fixation. The systems contain supracondylar tube/plates with angles of 90° and 95° and/or proximal femur tube/plates with angles from 130° to 150°. These systems share the lag and compression screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur, hip
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 - Accelerated aging testing conducted shows that the sterile devices included in this submission have a shelf life of 10 years.
- Biocompatibility - Biocompatibility testing of the subject devices was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.
- Performance Evaluation – A combination of performance testing (single cycle compression bending strength, fatigue compression bending strength and moment, four-point bend testing) and engineering analyses (beam bending cross sectional analysis) as appropriate demonstrate the subject devices are safe and effective and substantially equivalent to the predicate devices.
Conclusions: The data presented in this submission demonstrates that the subject devices are substantially equivalent to their respective predicate devices.
Clinical Performance and Conclusions:
Clinical trial 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.
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
§ 888.3030 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 & Human Services. The logo consists of the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other, with a flowing element beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Zimmer, Incorporated Mr. Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K150818 Trade/Device Name: Versa-Fx Femoral Fixation System. Versa-Fx II Femoral Fixation System, Free-lock Femoral Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT. HRS Dated: March 26, 2015 Received: March 27, 2015
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
May 1, 2015
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/ResourcesforYou/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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150818
Device Name
Versa-Fx Femoral Fixation System
Indications for Use (Describe)
The Versa-Fx Femoral Fixation System may be used for the internal fixation of supracondylar fractures with displaced intra-articular fragments, with verticular extension, and in the patient with multiple lower extremity fractures.
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
"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."
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Versa-Fx II Femoral Fixation System
Indications for Use (Describe)
Supracondylar: The Versa-Fx II Femoral Fixation System may be used for the internal fixation of supracondylar fractures with displaced intra-articular fragments, with vertical intra-articular extension, and in the patient with multiple lower extremity fractures.
Proximal Femur: The Versa-Fx II Femoral Fixation System may be used for internal fixation of hip fractures with application to intracapsular and intertrochanteric fractures, arthrodeses, and subtrochanteric fractures with extension into the greater trochanter and the piriformis fossa (Winquist Type III comminuted fracture).
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
"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."
4
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Free-Lock Femoral Fixation System
Indications for Use (Describe)
The Free-Lock Femoral Fixation System may be used for internal fixation of hip fractures with application to intracapsular and intertrochanteric fractures, osteotomies, arthrodeses, and subtrochanteric fractures with extension into the greater trochanter and the piriformis fossa (Winquist Type III comminuted fracture).
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
"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."
5
Image /page/5/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 lowercase blue letters.
510(k) Summary
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen H. McKelvey, MA, RAC
Senior Project Manager, Regulatory Affairs
Telephone: 574-372-4944
Fax: (574) 372-4605 |
| Date: | March 26, 2015 |
| Trade Name: | This is a bundled traditional 510(k). The trade names of
the three devices bundled in this submission are: |
| | 1) Versa-Fx® Femoral Fixation System
2) Versa-Fx® II Femoral Fixation System
2) Free-Lock® Femoral Fixation System |
| Common Name: | Appliance, Fixation, Nail/Blade/Plate Combination,
Multiple Component |
| Classification Names
and References: | Single/multiple component metallic bone fixation
appliances and accessories (21 CFR § 888.3030, KTT) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Dynamic Condylar Screw (DCS), manufactured by
Synthes (K840954, cleared May 11, 1984). |
| | Versa-Fx Femoral Fixation System, manufactured by
Zimmer (K954555, cleared January 26, 1996). |
| | Dynamic Hip Screw (DHS), manufactured by Synthes
(K791619, cleared August 28, 1979) |
6
Device Description:
Intended Use:
Zimmer is requesting clearance for modifications to the Versa-Fx, Versa-Fx II and Free-Lock Femoral Fixation Systems. The subject devices are similar in that they are used for either supracondylar or proximal femur fracture fixation. The systems contain supracondylar tube/plates with angles of 90° and 95° and/or proximal femur tube/plates with angles from 130° to 150°. These systems share the lag and compression screws.
Versa-Fx Femoral Fixation System:
The Versa-Fx Femoral Fixation System may be used for the internal fixation of supracondylar fractures with displaced intra-articular fragments, with vertical intraarticular extension, and in the patient with multiple lower extremity fractures.
Versa-Fx II Femoral Fixation System:
Supracondylar: The Versa-Fx II Femoral Fixation System may be used for the internal fixation of supracondylar fractures with displaced intra-articular fragments, with vertical intra-articular extension, and in the patient with multiple lower extremity fractures.
Proximal Femur: The Versa-Fx II Femoral Fixation System may be used for internal fixation of hip fractures with application to intracapsular and intertrochanteric fractures, osteotomies, arthrodeses, and subtrochanteric fractures with extension into the greater trochanter and the piriformis fossa (Winquist Type III comminuted fracture).
Free-Lock Femoral Fixation System:
The Free-Lock Femoral Fixation System may be used for internal fixation of hip fractures with application to intracapsular and intertrochanteric fractures, osteotomies, arthrodeses, and subtrochanteric fractures with extension into the greater trochanter and the piriformis fossa (Winquist Type III comminuted fracture).
Comparison to Predicate Device: The subject devices incorporate similar or identical materials, similar or identical indications for use, similar or identical sizes of implants, and the same technological characteristics as the predicate devices.
7
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
- o Shelf Life - Accelerated aging testing conducted shows that the sterile devices included in this submission have a shelf life of 10 years.
- . Biocompatibility - Biocompatibility testing of the subject devices was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.
- . Performance Evaluation – A combination of performance testing (single cycle compression bending strength, fatigue compression bending strength and moment, four-point bend testing) and engineering analyses (beam bending cross sectional analysis) as appropriate demonstrate the subject devices are safe and effective and substantially equivalent to the predicate devices.
Conclusions: The data presented in this submission demonstrates that the subject devices are substantially equivalent to their respective predicate devices.
Clinical Performance and Conclusions:
Clinical trial data and conclusions were not needed for these devices to show substantial equivalence.