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 .

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Affixus Natural Nail System Humeral Nail." This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It does not include information on acceptance criteria for a device performance study as typically seen in evaluations of AI/ML-driven devices.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance (such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth for training) are not applicable to this type of regulatory submission, which relies on demonstrating physical and mechanical equivalence through non-clinical testing.

Here's an analysis based on the information available:

A table of acceptance criteria and the reported device performance:
The document does not explicitly state "acceptance criteria" in the format of a performance study for, for example, accuracy, sensitivity, or specificity. Instead, the acceptance is based on the results of non-clinical performance tests demonstrating that the device is "as safe, as effective, and performs as well as or better than the legally marketed devices predicate." The performance is reported through the successful completion of various mechanical and biological tests.

Acceptance Criteria (Implicit)	Reported Device Performance
Bioburden requirements (ISO 11137-2)	Study performed, technical review completed.
Biocompatibility (ISO 10993-1)	Study performed.
Material composition (ASTM 136-13 for Tivanium® Ti-6Al-4V alloy)	Complies with material specifications.
Torsional Stiffness (no specific standard cited for this)	Measurement performed.
Static Four-Point Bend Test (no specific standard cited)	Performed.
Fatigue Strength (Three-point bending) (ASTM F543-17)	Evaluation performed.
Self-tapping Performance (no specific standard cited)	Performed.
Four-Point Bending Fatigue Properties (ASTM F1264-16)	Performed.
Driving Torque (no specific standard cited)	Determined.
Axial Pull-out Strength (no specific standard cited)	Determined.
Torsional Properties (ISO 6475)	Performed.
Bending fatigue strength and CoreLock Evaluation	Evaluation performed for the proximal segment.
Axial Push-out Strength (CoreLock mechanism)	Evaluation performed.
Cleaning, Autoclave, Targeting Functionality, Impact Testing	Performed for targeting guides.
Overall performance	"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. The results of non-clinical data demonstrate that the subject device is substantially equivalent with the predicate devices." (This is the ultimate 'performance' against the implicit criterion of substantial equivalence through testing).

Sample size used for the test set and the data provenance: Not applicable. These are non-clinical (mechanical, material, biological) tests, not studies involving patient data or test sets in the context of AI/ML. The "test set" would refer to the physical devices and components subjected to the various laboratory tests. The provenance is the manufacturer's internal testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these types of tests is established by engineering specifications, material standards, and validated testing protocols, not by expert medical review.
Adjudication method: Not applicable. This concept is relevant for clinical studies or studies using human interpretation (e.g., radiological reads), not for non-clinical mechanical or material testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is not an AI-assisted device; it's a physical intramedullary nail.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an algorithmic device.
The type of ground truth used: For non-clinical tests, the "ground truth" is typically defined by:
- Engineering Specifications: Design tolerances, material properties.
- Industry Standards: Adherence to standards like ISO 11137-2 (sterilization), ISO 10993-1 (biocompatibility), ASTM F136-13 (material), ASTM F543-17 (fatigue), ASTM F1264-16 (fatigue), ISO 6475 (torsional properties).
- Benchmarking against predicate devices: Performance (e.g., stiffness, strength) is compared to that of existing, legally marketed devices.
The sample size for the training set: Not applicable. This is not a machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary

{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 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:

Department of Health and Human Services Food and Druq 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}------------------------------------------------

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 GmbHSulzerallee 8, P.O. Box8404 Winterthur, Switzerland
Contact Person:	Danielle Jannuzzi MadureiraSenior Specialist, Regulatory AffairsTelephone: +41 58 854 82 60Fax: + 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) andK033806 (Ace® Proximal Humeral Nail System) both cleared in 20 February2004 and M/DN® Intramedullary Fixation System, manufactured by ZimmerInc, K142281 cleared 22 October 2014, K965098 cleared in 28 February 1997.
Device Description:	The Affixus Natural Nail System Humeral nails are temporary fixationintramedullary nails designed for fixation and stabilization of fractures orosteotomies of the humerus. They restore the shape of preinjured bone andare available in a variety of lengths and diameters to meet assorted anatomicalneeds.Nail caps are available to protect the nail threads from tissue ingrowth andextend the nail length if necessary. Each of the intramedullary nails is securedby a series of screws that pass through holes in the nail. Nails and nail capsare made from Tivanium® Ti-6Al-4V alloy. Screws are also made fromTivanium alloy. Package labels indicate the material of each component.Selected components of the Affixus Natural Nail System are color coded to aidin identifying which components should be used together. Refer to the colorcoding chart and/or surgical technique for more detailed instructions on the useof Affixus Natural Nail System components.
Intended Use andIndications for Use:	The Affixus® Natural Nail® System Humeral nails are temporary fixationintramedullary nails designed for fixation and stabilization of fractures orosteotomies of the humerus. They restore the shape of preinjured bone andare available in a variety of lengths and diameters to meet assorted anatomicalneeds. 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 issecured 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, suchas, 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 PredicateDevice:	The Affixus® Natural Nail® System Humeral nails, screws, washers, nail capscovered by this submission are similar in intended use, design, materials, andperformance characteristics to the predicate devices. The Differences in thetechnological characteristics between the primary predicate VersaNail and thesubject device Affixus® Natural Nail (ANN) Humeral Nail are as follows:
	• Proximal and distal locking screws diameter: subject device screws havesmaller diameters than the predicate device
	• Nail-screw configuration, including screw orientation: subject device has adifferent in range of the screw orientation (screw hole pattern) to thepredicate device. Adequate primary stability within all 3 planes can beachieved with both respective nails based on the screw insertion optionsprovided.
	• Axial compression: subject device provides an axial compressionmechanism in the long device variants (Proximal Long and AR), allowing acontrolled axial compression. The AR variant of the predicate device doesnot include such an option, and axial compression must be performed free-hand. However, the free-hand option can also be applied with the subjectdevice.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:
	Results of non-clinical performance testing and analyses demonstrate that theAffixus Humeral Nails is as safe, as effective, and performs as well as or betterthan the legally market devices predicate. Performance analyses included:
	1. Bioburden study and technical review of Affixus Humeral Nails NewProduct 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 corticalscrews using a three-point bending test setup
	6. Self-tapping performance of Affixus proximal blunt tip screw 4 mm andcortical 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 mmand 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.

Regulation Number and Section

§ 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.