Affixus(R) Natural Nail(R) System Humeral Nail

K200814 · Zimmer GmbH · HSB · Apr 28, 2020 · Orthopedic

Device Facts

• Record ID: K200814
• Device Name: Affixus(R) Natural Nail(R) System Humeral Nail
• Applicant: Zimmer GmbH
• Product Code: HSB · Orthopedic
• Decision Date: Apr 28, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Affixus Natural Nail System Humeral Nail; temporary intramedullary fixation device for humeral fractures/osteotomies. Device consists of nail, nail caps, and screws; implanted by orthopedic surgeons in clinical/OR settings. Nails inserted into humeral medullary canal; secured via screws passing through nail holes. Restores pre-injured bone shape; nail caps prevent tissue ingrowth into threads. Provides mechanical stabilization to facilitate bone healing. No software or electronic components.

Clinical Evidence

No clinical data provided; device relies on substantial equivalence to predicate.

Technological Characteristics

Intramedullary fixation rod; Tivanium® Ti-6Al-4V alloy construction; color-coded components for identification; various lengths/diameters; mechanical fixation via screws.

Indications for Use

Indicated for fixation and stabilization of humeral fractures or osteotomies, including proximal, diaphyseal, open, closed, comminuted, pathologic fractures, nonunions, and malunions.

Regulatory Classification

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.

Predicate Devices

• Affixus® Natural Nail® System Humeral Nails (K181827)

Reference Devices

• Zimmer® Natural Nail™ System Cephalomedullary Nails (K091566)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K200814

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 GmbH<br>Sulzerallee 8, P.O. Box<br>8404 Winterthur, Switzerland |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tiana Steinhoff<br>Senior Specialist, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| 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<br>GmbH, K181827 cleared on 14th December 2018 |
| Reference Device | Zimmer® Natural Nail™ System Cephalomedullary Nails<br>manufactured by Zimmer GmbH, K091566 cleared on 28th October<br>2009 |
| Device Description: | The Affixus Natural Nail System Humeral nails are temporary fixation<br>intramedullary nails designed for fixation and stabilization of fractures<br>or osteotomies of the humerus. They restore the shape of preinjured<br>bone and are available in a variety of lengths and diameters to meet<br>assorted anatomical needs.<br><br>Nail caps are available to protect the nail threads from tissue ingrowth<br>and extend the nail length if necessary. Each of the intramedullary<br>nails is secured by a series of screws that pass through holes in the<br>nail. Nails and nail caps are made from Tivanium® Ti-6Al-4V alloy.<br>Screws are also made from Tivanium alloy. Package labels indicate<br>the material of each component.<br><br>Selected components of the Affixus Natural Nail System are colour<br>coded to aid in identifying which components should be used<br>together. Refer to the colour coding chart and/or surgical technique for<br>more detailed instructions on the use of Affixus Natural Nail System<br>components. |
| Intended Use | The Affixus® Natural Nail® System Humeral nails are temporary<br>fixation intramedullary nails designed for fixation and stabilization of<br>fractures or osteotomies of the humerus. They restore the shape of<br>preinjured bone and are available in a variety of lengths and<br>diameters to meet assorted anatomical needs. Nail caps are available |
| | to protect the nail threads from tissue ingrowth and extend the nail<br>length if necessary. Each of the intramedullary nails is secured by a<br>series of screws that pass through holes in the nail. |
| | The Affixus® Humeral Nails are indicated for use in a variety of<br>fractures, such as, proximal fractures (proximal short and long nails<br>only), diaphyseal fractures (proximal long, antegrade/retrograde<br>nails), open and closed fractures, comminuted fractures, nonunions<br>and malunions and pathologic fractures. |
| Comparison to Predicate Device: | The intended use of the modified devices, as described in its labeling,<br>has not changed as a result of the modifications proposed in the<br>present submission. Design, materials and performance<br>characteristics remain unchanged. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions:<br>Non-clinical performance and conclusions were not needed for this<br>device.<br>Clinical Performance and Conclusions:<br>Clinical data and conclusions were not needed for this device |
| Conclusion: | The subject devices have the same intended use and same<br>indications for use as the predicate devices. The subject devices use<br>the same operating principle, incorporate the same basic design and<br>labeling and are manufactured and sterilized using the same materials<br>and processes as the predicate devices. |
| | Except for the modifications described in this submission the subject<br>devices are identical to the predicate devices, and the performance<br>data and analyses demonstrate that: |
| | ● any differences do not raise new questions of safety and<br>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.