The Affixus® Tibial Nailing System is indicated for temporary stabilization and fixation of tibial fractures and osteotomies including proximal. metaphyseal. and distal shaft fractures. closed fractures, open fractures, pathologic fractures, non-unions, malunions and deformity corrections.

The Affixus® Antegrade Femoral Nailing System is indicated for temporary stabilization and fixation of femoral fractures and osteotomies including proximal, metaphyseal, and distal shaft fractures, trochanteric and subtrochanteric fractures, closed fractures, pathologic fractures, non-unions, malunions and deformity corrections.

Device Description

The Affixus Tibial Nailing System and the Affixus Antegrade Femoral (AF) Nailing System are long bone nailing systems that offer implants designed to treat a range of tibial and femoral fractures from simple to complex, with versatile locking options. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Screws and End Caps are included in the system. All implants are made of Ti-6Al-4V. The Affixus platform of instrumentation is designed to provide options and flexibility for many intraoperative approaches while maintaining ease of use and commonality.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, specifically the Affixus Tibial and Antegrade Femoral Nailing System. These notifications are submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, meaning it is at least as safe and effective.

The provided text does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a study that proves the device meets those criteria, particularly in the context of an AI/algorithm-based device. This document is for a traditional medical implant, not an AI software as a medical device (SaMD).

Therefore, many of the requested fields are not applicable or cannot be extracted from the given text. However, I can provide information based on what is available.

Here's the breakdown of what can be inferred and what is missing:

Acceptance Criteria and Device Performance Study

As this is a 510(k) for a physical medical implant (intramedullary fixation rod), the concept of "acceptance criteria" and "device performance" in the context of an AI/algorithm is not directly applicable in the same way. Instead, the "acceptance criteria" can be interpreted as demonstrating substantial equivalence to predicate devices through various non-clinical tests. The "device performance" is demonstrated by meeting the standards and benchmarks set by these tests.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category (Implied)	Specific Tests Performed (Reported Device Performance)
Mechanical Strength & Durability	- Screw Disengagement
	- Construct Bending Fatigue Strength
	- Nail Static Bending Strength/Stiffness per ASTM F1264 Annex 1
	- Nail Bending Fatigue Strength per ASTM F1264 Annex 3
	- Nail Static Torsional Stiffness per ASTM F1264 Annex 2
	- Bone Screw Bending Strength per ASTM F1264 Annex 4
Screw Properties	- Locking Mechanism Torque
	- Screw Maximum Torque to Failure and Breaking Angle per ASTM F543 Annex 1
	- Screw Insertion/Removal Torque per ASTM F543 Annex 2
	- Screw Pullout Strength per ASTM F543 Annex 3
	- Screw Self Tapping Performance per ASTM F543 Annex 4
Biocompatibility/Safety	- MR Compatibility Evaluation per ASTM F2182, ASTM F2052, F2119, ASTM 2213
Overall Equivalence	- Demonstrated similar intended use and technological characteristics to predicates, with differences not raising new questions of safety/effectiveness.
	- Proposed device is at least as safe and effective as legally marketed predicate devices.

Explanation of Performance: The document explicitly states: "The information provided herein demonstrates that: any differences do not raise different questions of safety and effectiveness; and the proposed device is at least as safe and effective as the legally marketed predicate devices." This is the ultimate "performance" metric for a 510(k) submission, achieved by passing the listed non-clinical tests and demonstrating material, design, packaging, and sterilization similarity to predicate devices. The specific values or pass/fail thresholds for each test are not provided in this summary, but the successful submission implies they were met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the provided text. For mechanical testing of implants, sample sizes typically adhere to relevant ASTM standards.
Data Provenance: Not specified in the provided text. These are non-clinical lab tests, so country of origin for "data" is typically the testing lab's location. The tests are prospective in the sense that they are specifically conducted for the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This is a physical implant, not an AI/algorithm requiring expert-established ground truth on image data or other patient data. The "ground truth" for these tests are the defined mechanical properties and physical characteristics as per the ASTM standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This is a physical implant. The mechanical tests are objective measurements, not subject to adjudication by human interpreters.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is for a physical implant. No AI component is mentioned, and therefore, no MRMC study or human reader improvement with AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is for a physical implant. No algorithm is mentioned.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Mechanical Test Standards: The "ground truth" for the non-clinical tests are the specified mechanical properties and performance requirements outlined in the referenced ASTM standards (e.g., ASTM F1264, ASTM F543, ASTM F2182, etc.). These standards define acceptable ranges for strength, fatigue, torque, etc., which the device must meet or exceed.

8. The sample size for the training set

Not Applicable. This is for a physical implant; there is no "training set" in the context of an AI/machine learning model.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set, this question is not relevant.

Summary of what the document does indicate for this physical device:

The submission highlights that the Affixus Tibial and Antegrade Femoral Nailing System is deemed substantially equivalent to predicate devices based on:

Similar indications for use.
Similar technological characteristics (materials, design features, packaging, sterilization).
Successful completion of a battery of non-clinical mechanical and MR compatibility tests.

The goal of this 510(k) is to demonstrate that the new device does not raise new questions of safety or effectiveness compared to legally marketed predicate devices. The listed non-clinical tests are the evidence used to support this claim.

Summary

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September 26, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Zimmer Inc. Giraldo Anderson Regulatory Affairs Sr. Specialist 1800 W Center Street Warsaw, Indiana 46580

Re: K241651

Trade/Device Name: Affixus Tibial and Antegrade Femoral Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC Dated: June 7, 2024 Received: August 26, 2024

Dear Giraldo Anderson:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely, Joseph P. Russell Digitally signed by Joseph P.
Russell -S -5 Date: 2024.09.26 12:14:44 -04'00' for: Farzana Sharmin, PhD 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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Indications for Use

K241651 Page 1 of 1 Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241651

Device Name

Affixus Tibial and Antegrade Femoral Nailing System

Indications for Use (Describe)

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:

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K241651 Page 1 of 2 510(k) Summary 510(k) #: K241651 Prepared on: 2024-09-26 Contact Details 21 CFR 807.92(a)(1) Applicant Name Zimmer Inc. Applicant Address 1800 W Center Street Warsaw IN 46580 United States Applicant Contact Telephone 1-978-908-0222 Applicant Contact Mr. Akash Savalia akash.savalia@zimmerbiomet.com Applicant Contact Email Correspondent Name Zimmer Inc. Correspondent Address 1800 W Center Street Warsaw IN 46580 United States Correspondent Contact Telephone 1-754-215-1051 Correspondent Contact Mr. Anderson Giraldo Correspondent Contact Email anderson.giraldo@zimmerbiomet.com

Device Name

Device Trade Name	Affixus Tibial and Antegrade Femoral Nailing System
Common Name	Rod, Fixation, Intramedullary And Accessories
Classification Name	Intramedullary fixation rod

Regulation Number

Product Code(s)

HSB, HWC

888.3020

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

21 CFR 807.92(a)(2

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K082770	Zimmer Natural Nail System - Tibial Nail	HSB
K063570	Biomet Tibial Locking Nail System	HSB
K083497	ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA ANDImage: plus sign	HSB
K072161	Biomet Femoral Locking Nailing System	HSB
K091566	Zimmer® Natural Nail® System Cephalomedullary Nails	HSB
K231114	Zimmer® Natural Nail® System Cephalomedullary Nails	HSB

21 CFR 807.92(a)(4

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21 CFR 807.92(a)(5)

Intended Use/Indications for Use

The Affixus® Tibial Nailing System is indication and fixation of tibial fractures and osteotomies including proximal, metaphyseal, and distal shaft fractures, open fractures, pathologic fractures, non-unions, malunions and deformity corrections.

The Affixus® Antegrade Femoral Nailing System is indication and fixation of femoral fractures and osteotomies including proximal, metaphyseal, and distal shaft fractures, trochanteric fractures, closed fractures, open fractures, pathologic fractures, non-unions, malunions and deformity corrections.

Indications for Use Comparison

The indications for use are similar between the predicate and the subject device. As demonstrated in this submission, including non-clinical tests, the subject device is sated indications for use despite any differences to the predicates.

Technological Comparison

The proposed device has similar technological characteristics as the primary predicate system. The rationale for substantial equivalence is based on consideration of the following characteristics:

Materials: Identical to primary predicate device implants
Design Features: Similar to predicate devices. Minor differences in features, including implant geometry, do not affect safety or
effectiveness as supported by non-clinical tests included in this submission.
· Packaging: Similar to predicate devices
· Sterilization: Similar to primary predicate device

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Non-Clinical Tests:

· Screw Disengagement
Construct Bending Fatigue Strength
· Locking Mechanism Torque
Nail Static Bending Strength/ Stiffness per ASTM F1264 Annex 1
· Nail Bending Fatigue Strength per ASTM F1264 Annex 3
Nail Static Torsional Stiffness per ASTM F1264 Annex 2
· Bone Screw Bending Strength per ASTM F1264 Annex 4
Screw Maximum Torque to Failure and Breaking Angle per ASTM F543 Annex 1
· Screw Insertion/ Removal Torque per ASTM F543 Annex 2
· Screw Pullout Strength per ASTM F543 Annex 3
· Screw Self Tapping Performance per ASTM F543 Annex 4
· MR Compatibility Evaluation per ASTM F2182, ASTM F2052, F2119, ASTM 2213

The proposed device has a similar intended use as the predicates and similar technological characteristics. The information provided herein demonstrates that:

· any differences do not raise different questions of safety and effectiveness; and
· the proposed device is at least as safe and effective as the legally marketed predicate devices.

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)

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.