(29 days)
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
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.
The provided text is an FDA 510(k) clearance letter and a 510(k) Summary for the Affixus® Natural Nail® System Humeral Nail. This device is an intramedullary fixation rod, which is a physical device used for stabilizing fractures.
The requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is typically associated with the evaluation of AI/ML-based medical devices or diagnostic tools, where performance is measured against a ground truth and often involves human reader studies.
For the Affixus® Natural Nail® System Humeral Nail, an intramedullary fixation rod, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as requested is not applicable in the same way it would be for an AI diagnostic device.
Here's why and how to interpret the provided document:
- This is a physical medical device clearance, not an AI/ML device clearance. The FDA document is about a Class II medical device (intramedullary fixation rod) for fixing humeral fractures not a software.
- Substantial Equivalence: The clearance is based on substantial equivalence to a previously cleared predicate device (K181827). This means the FDA determined the new device is as safe and effective as the predicate without raising new questions of safety or effectiveness.
- Performance Data: The 510(k) Summary explicitly states:
- "Non-clinical performance and conclusions were not needed for this device."
- "Clinical data and conclusions were not needed for this device."
- This is because the device is largely identical to its predicate, and any minor modifications did not warrant new performance data.
- Acceptance Criteria for Physical Devices: For physical devices like this, acceptance criteria typically involve engineering specifications, biocompatibility, mechanical testing (e.g., fatigue, torsional strength, bending strength), and sterilization validation, rather than diagnostic performance metrics like sensitivity, specificity, or AUC against a ground truth. These tests ensure the device meets required functional and safety standards. However, the document states "performance testing" was done to address differences, but it doesn't detail these tests or criteria because no new questions of safety/effectiveness were raised.
Therefore, it is not possible to extract the requested information (table of acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document for the following reasons:
- Nature of the Device: It's a physical implant, not a diagnostic AI.
- Regulatory Pathway: 510(k) clearance based on substantial equivalence, especially for minor modifications, often relies on existing data for the predicate device and does not always require new extensive performance studies for the modified device if no new questions of safety or effectiveness are raised.
- Explicit Statement: The document clearly states that non-clinical and clinical performance data were not needed for this submission.
In summary, the provided document does not contain the specific type of acceptance criteria and study details (especially related to human-in-the-loop, MRMC, or standalone performance against a ground truth) that would be relevant for an AI/ML diagnostic device. The "performance data" mentioned in the document refers to the demonstration that "any differences do not raise new questions of safety and effectiveness as established with performance testing" and that the devices are "at least as safe and effective as the legally marketed predicate devices." This implies that prior engineering and safety testing for the predicate device were sufficient, and no new, extensive clinical or non-clinical performance studies were required for this specific 510(k) submission to prove substantial equivalence.
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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
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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
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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)
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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 GmbHSulzerallee 8, P.O. Box8404 Winterthur, Switzerland |
|---|---|
| Contact Person: | Tiana SteinhoffSenior Specialist, Regulatory AffairsTelephone: +41 58 854 82 96Fax: +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 ZimmerGmbH, K181827 cleared on 14th December 2018 |
| Reference Device | Zimmer® Natural Nail™ System Cephalomedullary Nailsmanufactured by Zimmer GmbH, K091566 cleared on 28th October2009 |
| Device Description: | The Affixus Natural Nail System Humeral nails are temporary fixationintramedullary nails designed for fixation and stabilization of fracturesor osteotomies of the humerus. They restore the shape of preinjuredbone and are available in a variety of lengths and diameters to meetassorted anatomical needs.Nail caps are available to protect the nail threads from tissue ingrowthand extend the nail length if necessary. Each of the intramedullarynails is secured by a series of screws that pass through holes in thenail. Nails and nail caps are made from Tivanium® Ti-6Al-4V alloy.Screws are also made from Tivanium alloy. Package labels indicatethe material of each component.Selected components of the Affixus Natural Nail System are colourcoded to aid in identifying which components should be usedtogether. Refer to the colour coding chart and/or surgical technique formore detailed instructions on the use of Affixus Natural Nail Systemcomponents. |
| Intended Use | The Affixus® Natural Nail® System Humeral nails are temporaryfixation intramedullary nails designed for fixation and stabilization offractures or osteotomies of the humerus. They restore the shape ofpreinjured bone and are available in a variety of lengths anddiameters to meet assorted anatomical needs. Nail caps are available |
| to protect the nail threads from tissue ingrowth and extend the naillength if necessary. Each of the intramedullary nails is secured by aseries of screws that pass through holes in the nail. | |
| The Affixus® Humeral Nails are indicated for use in a variety offractures, such as, proximal fractures (proximal short and long nailsonly), diaphyseal fractures (proximal long, antegrade/retrogradenails), open and closed fractures, comminuted fractures, nonunionsand 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 thepresent submission. Design, materials and performancecharacteristics remain unchanged. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions:Non-clinical performance and conclusions were not needed for thisdevice.Clinical Performance and Conclusions:Clinical data and conclusions were not needed for this device |
| Conclusion: | The subject devices have the same intended use and sameindications for use as the predicate devices. The subject devices usethe same operating principle, incorporate the same basic design andlabeling and are manufactured and sterilized using the same materialsand processes as the predicate devices. |
| Except for the modifications described in this submission the subjectdevices are identical to the predicate devices, and the performancedata and analyses demonstrate that: | |
| ● any differences do not raise new questions of safety andeffectiveness 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.
§ 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.