(111 days)
No
The device description and performance studies focus on the mechanical properties and functionality of the bone nailing system, with no mention of AI or ML.
Yes
The device is described as a system for temporary stabilization and fixation of bone fractures and osteotomies, which directly addresses a health condition (fractures) and aims to restore normal function.
No
This device is a surgical implant (nailing system) used for temporary stabilization and fixation of bone fractures and osteotomies. It does not provide diagnostic information about a patient's medical condition.
No
The device description explicitly states it is a "long bone nailing system" that includes "implants" made of Ti-6Al-4V, "screws," and "end caps." This indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for the temporary stabilization and fixation of bone fractures and osteotomies in the tibia and femur. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The description details a system of implants (nails, screws, end caps) made of Ti-6Al-4V, designed to be inserted into bone. This is consistent with orthopedic implants used in surgery.
- Lack of IVD characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the living body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to perform tests on biological samples to provide information about a person's health. This device is a surgical implant used to treat a physical injury (fracture).
N/A
Intended Use / Indications for Use
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.
Product codes
HSB, HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibial, Femoral
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
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
Key results: The proposed device is at least as safe and effective as the legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K082770, K063570, K083497, K072161, K091566, K231114
Reference Device(s)
Not Found
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
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).
1
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).
2
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
3
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)
Device Name
Affixus Tibial and Antegrade Femoral Nailing System
Indications for Use (Describe)
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.
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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4
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 AND | |
| Image: 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
5
21 CFR 807.92(a)(5)
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.
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)