(31 days)
Not Found
No
The summary describes a mechanical bone screw system and associated tools. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies focus on mechanical properties and shelf life.
No
The device is a cannulated bone screw system used for orthopedic fixation of fractures, not for therapeutic treatment.
No
The device is a bone screw used for fracture fixation, which is a therapeutic purpose, not a diagnostic one. While it mentions image intensification fluoroscopy for accurate placement, the device itself does not perform diagnosis.
No
The device description clearly states it consists of "cannulated bone screws" and an "associated washer," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of bone fractures and other orthopedic applications. This is a surgical/implantable device, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details bone screws and associated hardware, which are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are used in vitro (outside the body) 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 in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The Magna-FX Cannulated Bone Screws are indicated for fractures of: The intracapsular hip, femoral condyles, tibial condyles, ankle, acetabulum, pelvis, and other areas where accurate screw placement is required. The screw can also be applied to slipped capital femoral epiphysis if image intensification fluoroscopy is used to ascertain the proper position of the screw.
The Mini Magna-FX Cannulated Bone Screws are indicated for: Fractures of the medial malleolus, distal tibia, distal radius, calcaneus, talus, patella, and pelvis. It can also be used in the reduction of small bone fragments and reduction and fixation with cerclage wire, and the fixation of bone prominences.
Product codes (comma separated list FDA assigned to the subject device)
HWC, NDG
Device Description
The Magna-FX Cannulated Screw Fixation System consists of a line of cannulated bone screws that are self-reaming and self-tapping and an associated washer. Magna-FX screws are designed to provide rigid fixation for various fractures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracapsular hip, femoral condyles, tibial condyles, ankle, acetabulum, pelvis, medial malleolus, distal tibia, distal radius, calcaneus, talus, patella, small bone fragments, bone prominences
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 Testing – Testing performed included evaluation of screw torsional properties and axial pull out strength per ASTM F543. The results of non-clinical performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.
Conclusions: The non-clinical performance data presented in this submission show that the devices are substantially equivalent to the predicate devices.
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.
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, layered on top of each other. The profiles are connected by a flowing, ribbon-like shape that extends from the bottom of the first profile to the bottom of the third. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3, 2014
Zimmer, Incorporated Mr. Stephen H. McKelvey, MA, RAC Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K142442
Trade/Device Name: Magna-FX® Cannulated Screw Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC. NDG Dated: August 29, 2014 Received: September 2, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. Stephen H. McKelvey, MA, RAC
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.
Ronald###ean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142442
Device Name
Magna-FX Cannulated Screw Fixation System
Indications for Use (Describe)
The Magna-FX Cannulated Bone Screws are indicated for fractures of:
· The intracapsular hip, femoral condyles, ankle, acetabulum, pelvis, and other areas where accurate screw placement is required.
· The screw can also be applied to slipped capital femoral epiphysis if image intensification fluoroscopy is used to ascertain the proper position of the screw.
The Mini Magna-FX Cannulated Bone Screws are indicated for:
· Fractures of the medial malleolus, distal tibia, distal radius, calcaneus, talus, patella, and pelvis.
· It can also be used in the reduction of small bone fragments and fixation with cerclage wire, and the fixation of bone prominences.
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
Image /page/3/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo features a blue circle with a stylized white "Z" inside. Below the circle, the word "zimmer" is written 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: | September 22, 2014 |
| Trade Name: | Magna-FX® Cannulated Screw Fixation System |
| Common Name: | Screw, Fixation, Bone Washer, Bolt, Nut, Non-Spinal, Metallic |
| Classification Names and References: | Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040, HWC) Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030, NDG) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Cannulated Screws and Washers, manufactured by Smith & Nephew, Inc., K111994, cleared October 11, 2011. Synthes 6.5 mm Cannulated Screw, manufactured by Synthes, K021932, cleared September 6, 2002. |
| Purpose and Device Description: | The Magna-FX Cannulated Screw Fixation System consists of a line of cannulated bone screws that are self- reaming and self-tapping and an associated washer. Magna-FX screws are designed to provide rigid fixation for various fractures. |
4
| Intended Use: | The Magna-FX Cannulated Bone Screws are indicated for
fractures of: The intracapsular hip, femoral condyles, tibial
condyles, ankle, acetabulum, pelvis, and other areas where
accurate screw placement is required. The screw can also
be applied to slipped capital femoral epiphysis if image
intensification fluoroscopy is used to ascertain the proper
position of the screw. |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Mini Magna-FX Cannulated Bone Screws are
indicated for: Fractures of the medial malleolus, distal
tibia, distal radius, calcaneus, talus, patella, and pelvis. It
can also be used in the reduction of small bone fragments
and reduction and fixation with cerclage wire, and the
fixation of bone prominences. |
| Performance Data (Nonclinical
and/or Clinical): | 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 Testing – Testing performed included
evaluation of screw torsional properties and axial pull
out strength per ASTM F543. The results of non-
clinical performance testing demonstrate that the
devices are safe and effective and substantially
equivalent to the predicate devices. |
| | Conclusions: The non-clinical performance data presented
in this submission show that the devices are substantially |
substantial equivalence.
equivalent to the predicate devices. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for these devices to show