(158 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a traditional intramedullary nail system for fracture fixation. There is no mention of software, algorithms, image processing, or any other components typically associated with AI/ML in medical devices.
Yes
The device is an intramedullary nail used for the fixation and stabilization of fractures or osteotomies of the humerus, which is a therapeutic intervention aimed at restoring the shape of preinjured bone.
No
The device is described as an intramedullary nail system for fixation and stabilization of fractures, which is a therapeutic purpose, not diagnostic.
No
The device description clearly states it is a system of intramedullary nails, screws, and nail caps made from Tivanium alloy, 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 states the device is for "temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus." This describes a surgical implant used in vivo (within the body) for structural support.
- Device Description: The description reinforces this by detailing the materials and components of the intramedullary nails and screws, which are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings for analysis of biological samples.
Therefore, the AFFIXUS Natural Nail System Humeral nails are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AFFIXUS Natural Nail System Humeral nails are temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail.
The AFFIXUS Humeral Nails are indicated for use in a variety of fractures, such as:
- · Proximal fractures (proximal short and long nails only)
- · Diaphyseal fractures (proximal long, antegrade/retrograde nails)
- Open and closed fractures
- · Comminuted fractures
- Nonunions and malunions
- · Pathologic fractures .
Product codes
HSB
Device Description
The Affixus Natural Nail System Humeral nails are temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail. Nails and nail caps are made from Tivanium® Ti-6Al-4V alloy. Screws are also made from Tivanium alloy. Package labels indicate the material of each component. Selected components of the Affixus Natural Nail System are color coded to aid in identifying which components should be used together. Refer to the color coding chart and/or surgical technique for more detailed instructions on the use of Affixus Natural Nail System components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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:
Results of non-clinical performance testing and analyses demonstrate that the Affixus Humeral Nails is as safe, as effective, and performs as well as or better than the legally market devices predicate. Performance analyses included:
- Bioburden study and technical review of Affixus Humeral Nails New Product Introduction (NPI) project
- Biocompatibility of Affixus® Natural Nail® (ANN) Humeral Nail
- Measurement of Torsional Stiffness of Affixus Humeral Nails
- Static four point bend test of Affixus Humeral Nails
- Fatigue strength evaluation of the Affixus blunt tip screw and cortical screws using a three-point bending test setup
- Self-tapping performance of Affixus proximal blunt tip screw 4 mm and cortical bone screw 4 mm
- Four point bending fatigue properties of Affixus Humeral Nails
- Determining the driving torque of Affixus Proximal blunt tip screw 4 mm and cortical bone screw 4 mm
- Determining the axial pull-out strength of Affixus Proximal blunt tip screw 4 mm and cortical bone screw 4 mm
- Torsional properties of the Affixus Proximal blunt tip screw 4 mm and cortical bone screw 4 mm
- Bending fatigue strength and CoreLock Evaluation of the proximal segment (including the mid-shaft segment) of the Affixus Humeral Nail system
- Axial push-out strength evaluation of the Affixus Humeral Nail locking screw fixed by the CoreLock mechanis
- Cleaning, autoclave, targeting functionality and impact testing of the Affixus Humerus targeting guides
The tests were performed according to the applicable Standards: ISO 11137-2, ISO 10993-1, ASTM 136-13, ASTM F543-17, ASTM F1264-16, and ISO 6475.
Clinical Performance and Conclusions:
The results of non-clinical data demonstrate that the subject device is substantially equivalent with the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K033878, K033806, K142281, K965098
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 14, 2018
Zimmer GmbH Danielle Madureira Senior Specialist, Regulatory Affairs Sulzerallee 8 Winterthur, 8404 Switzerland
Re: K181827
Trade/Device Name: Affixus Natural Nail System Humeral Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: November 8, 2018 Received: November 13, 2018
Dear Danielle Madureira:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vesa
Vuniqi -S
Digitally signed
by Vesa Vuniqi -S
Date: 2018.12.14
16:07:07 -05'00'
For:
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)
K181827
Device Name
AFFIXUS® NATURAL NAIL® SYSTEM HUMERAL NAIL
Indications for Use (Describe)
The AFFIXUS Natural Nail System Humeral nails are temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail.
The AFFIXUS Humeral Nails are indicated for use in a variety of fractures, such as:
- · Proximal fractures (proximal short and long nails only)
- · Diaphyseal fractures (proximal long, antegrade/retrograde nails)
- Open and closed fractures
- · Comminuted fractures
- Nonunions and malunions
- · Pathologic fractures .
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020 See PRA Statement below.
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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:
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3
mise." Your prog
510(K) SUMMARY
SAP Title: 510(k) Summary
SAP Document: RA2-380737-E00-03
WT-FO 386809 Revision 01 Page 1 of 3
510(k) SUMMARY
| Sponsor: | Zimmer GmbH
Sulzerallee 8, P.O. Box
8404 Winterthur, Switzerland |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Danielle Jannuzzi Madureira
Senior Specialist, Regulatory Affairs
Telephone: +41 58 854 82 60
Fax: + 41 52 244 86 58 |
| Date: | June 29th, 2018 |
| Trade Name: | Affixus® Natural Nail® System Humeral Nail |
| Classification Product Code : | HSB - Intramedullary Fixation Rod |
| Device Classification Name: | Rod, fixation, intramedullary and accessories |
| Regulation Number /
Description: | 21 CFR § 888.3020 number - Intramedullary fixation rod |
| Predicate Device: | Versanail® Nailing System, manufactured by Biomet Trauma Inc, K033878
(Ace® Antegrade Retrograde Humeral Nail System, primary predicate) and
K033806 (Ace® Proximal Humeral Nail System) both cleared in 20 February
2004 and M/DN® Intramedullary Fixation System, manufactured by Zimmer
Inc, K142281 cleared 22 October 2014, K965098 cleared in 28 February 1997. |
| Device Description: | The Affixus Natural Nail System Humeral nails are temporary fixation
intramedullary nails designed for fixation and stabilization of fractures or
osteotomies of the humerus. They restore the shape of preinjured bone and
are available in a variety of lengths and diameters to meet assorted anatomical
needs.
Nail caps are available to protect the nail threads from tissue ingrowth and
extend the nail length if necessary. Each of the intramedullary nails is secured
by a series of screws that pass through holes in the nail. Nails and nail caps
are made from Tivanium® Ti-6Al-4V alloy. Screws are also made from
Tivanium alloy. Package labels indicate the material of each component.
Selected components of the Affixus Natural Nail System are color coded to aid
in identifying which components should be used together. Refer to the color
coding chart and/or surgical technique for more detailed instructions on the use
of Affixus Natural Nail System components. |
| Intended Use and
Indications for Use: | The Affixus® Natural Nail® System Humeral nails are temporary fixation
intramedullary nails designed for fixation and stabilization of fractures or
osteotomies of the humerus. They restore the shape of preinjured bone and
are available in a variety of lengths and diameters to meet assorted anatomical
needs. Nail caps are available to protect the nail threads from tissue ingrowth |
4
WT-FO 386809
| SAP Title: 510(k) Summary | WT-FO 386809 | |
|---|---|---|
| SAP Document: RA2-380737-E00-03 | Revision 01 | |
| Page 2 of 3 | ||
| and extend the nail length if necessary. Each of the intramedullary nails is | ||
| secured by a series of screws that pass through holes in the nail. | ||
| The Affixus® Humeral Nails are indicated for use in a variety of fractures, such | ||
| as, proximal fractures (proximal short and long nails only), diaphyseal fractures | ||
| (proximal long, antegrade/retrograde nails), open and closed fractures, | ||
| comminuted fractures, nonunions and malunions and pathologic fractures.. | ||
| Comparison to Predicate | ||
| Device: | The Affixus® Natural Nail® System Humeral nails, screws, washers, nail caps | |
| covered by this submission are similar in intended use, design, materials, and | ||
| performance characteristics to the predicate devices. The Differences in the | ||
| technological characteristics between the primary predicate VersaNail and the | ||
| subject device Affixus® Natural Nail (ANN) Humeral Nail are as follows: | ||
| • Proximal and distal locking screws diameter: subject device screws have | ||
| smaller diameters than the predicate device | ||
| • Nail-screw configuration, including screw orientation: subject device has a | ||
| different in range of the screw orientation (screw hole pattern) to the | ||
| predicate device. Adequate primary stability within all 3 planes can be | ||
| achieved with both respective nails based on the screw insertion options | ||
| provided. | ||
| • Axial compression: subject device provides an axial compression | ||
| mechanism in the long device variants (Proximal Long and AR), allowing a | ||
| controlled axial compression. The AR variant of the predicate device does | ||
| not include such an option, and axial compression must be performed free- | ||
| hand. However, the free-hand option can also be applied with the subject | ||
| device. | ||
| Performance Data (Nonclinical | ||
| and/or Clinical): | Non-Clinical Performance and Conclusions: | |
| Results of non-clinical performance testing and analyses demonstrate that the | ||
| Affixus Humeral Nails is as safe, as effective, and performs as well as or better | ||
| than the legally market devices predicate. Performance analyses included: | ||
| 1. Bioburden study and technical review of Affixus Humeral Nails New | ||
| Product Introduction (NPI) project | ||
| 2. Biocompatibility of Affixus® Natural Nail® (ANN) Humeral Nail | ||
| 3. Measurement of Torsional Stiffness of Affixus Humeral Nails | ||
| 4. Static four point bend test of Affixus Humeral Nails | ||
| 5. Fatigue strength evaluation of the Affixus blunt tip screw and cortical | ||
| screws using a three-point bending test setup | ||
| 6. Self-tapping performance of Affixus proximal blunt tip screw 4 mm and | ||
| cortical bone screw 4 mm | ||
| 7. Four point bending fatigue properties of Affixus Humeral Nails | ||
| 8. Determining the driving torque of Affixus Proximal blunt tip screw 4 mm | ||
| and cortical bone screw 4 mm | ||
510(K) SUMMARY
SAP Title: 510(k) Summary
5
Image /page/5/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a white "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. Below the company name is the tagline "Your progress. Our promise." in a smaller font size.
510(K) SUMMARY
SAP Title: 510(k) Summary
WT-FO 386809 Revision 01 Page 3 of 3
SAP Document: RA2-380737-E00-03
-
Determining the axial pull-out strength of Affixus Proximal blunt tip screw 4 mm and cortical bone screw 4 mm
-
Torsional properties of the Affixus Proximal blunt tip screw 4 mm and cortical bone screw 4 mm
-
Bending fatigue strength and CoreLock Evaluation of the proximal segment (including the mid-shaft segment) of the Affixus Humeral Nail system
-
Axial push-out strength evaluation of the Affixus Humeral Nail locking screw fixed by the CoreLock mechanis
-
Cleaning, autoclave, targeting functionality and impact testing of the Affixus Humerus targeting guides
The tests were performed according to the applicable Standards: ISO 11137-2, ISO 10993-1, ASTM 136-13, ASTM F543-17, ASTM F1264-16, and ISO 6475.
Clinical Performance and Conclusions:
The results of non-clinical data demonstrate that the subject device is substantially equivalent with the predicate devices.