(29 days)
No
The description focuses on the physical components and intended use of a traditional intramedullary nail system for fracture fixation, with no mention of AI or ML capabilities.
Yes.
The device is an intramedullary nail designed for fixation and stabilization of bone fractures, which is a therapeutic purpose.
No
The device description clearly states its purpose is for "fixation and stabilization of fractures or osteotomies of the humerus," and it is used to "restore the shape of preinjured bone." It is an implantable medical device, not designed to diagnose a condition, but to treat it.
No
The device description explicitly states it is an intramedullary nail system made of Tivanium alloy, which is a hardware implant.
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 "fixation and stabilization of fractures or osteotomies of the humerus." This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical implant (intramedullary nails, screws, caps) made of metal alloy, designed to be surgically placed within the bone. This is consistent with a medical device for treatment, not a diagnostic tool.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
The device is a surgical implant used to treat bone fractures.
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 preiniured 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 colour coded to aid in identifying which components should be used together. Refer to the colour 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
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:
Non-clinical performance and conclusions were not needed for this device.
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)
Affixus® Natural Nail® System Humeral Nails manufactured by Zimmer GmbH, K181827
Reference Device(s)
Zimmer® Natural Nail™ System Cephalomedullary Nails manufactured by Zimmer GmbH, K091566
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
April 28, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an eagle and text around it. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of "ADMINISTRATION". The logo is simple and professional, and it is easily recognizable.
Zimmer GmbH Tiana Steinhoff Senior Specialist, Regulatory Affairs Sulzerallee 8, P.O. Box 8404 WINTERTHUR. Switzerland
Re: K200814
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: March 24, 2020 Received: March 30, 2020
Dear Tiana Steinhoff:
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. 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For: Michael Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
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 preiniured 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) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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:
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/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is in a darker shade of gray or black, providing a contrast against the white background.
510(k) Summary
| Sponsor: | Zimmer GmbH
Sulzerallee 8, P.O. Box
8404 Winterthur, Switzerland |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tiana Steinhoff
Senior Specialist, Regulatory Affairs
Telephone: +41 58 854 82 96
Fax: +41 52 244 86 58 |
| Date: | March 24th 2020 |
| 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: | Affixus® Natural Nail® System Humeral Nails manufactured by Zimmer
GmbH, K181827 cleared on 14th December 2018 |
| Reference Device | Zimmer® Natural Nail™ System Cephalomedullary Nails
manufactured by Zimmer GmbH, K091566 cleared on 28th October
2009 |
| 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 colour
coded to aid in identifying which components should be used
together. Refer to the colour coding chart and/or surgical technique for
more detailed instructions on the use of Affixus Natural Nail System
components. |
| Intended 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 and pathologic fractures. |
| Comparison to Predicate Device: | The intended use of the modified devices, as described in its labeling,
has not changed as a result of the modifications proposed in the
present submission. Design, materials and performance
characteristics remain unchanged. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
Non-clinical performance and conclusions were not needed for this
device.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device |
| Conclusion: | The subject devices have the same intended use and same
indications for use as the predicate devices. The subject devices use
the same operating principle, incorporate the same basic design and
labeling and are manufactured and sterilized using the same materials
and processes as the predicate devices. |
| | Except for the modifications described in this submission the subject
devices are identical to the predicate devices, and the performance
data and analyses demonstrate that: |
| | ● any differences do not raise new questions of safety and
effectiveness as established with performance testing; and |
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Image /page/4/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is in a dark gray color. The logo is simple and modern.
- the subject devices are at least as safe and effective as the ● legally marketed predicate devices.