(167 days)
No
The device description and intended use clearly define the device as a set of intramedullary nails and associated hardware for fracture fixation. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The performance studies focus on physical properties, packaging, and sterility, not algorithmic performance.
Yes
The device is described as an intramedullary nail system intended for the fixation of various types of bone fractures, which is a therapeutic function.
No
The device is an intramedullary nail system used for the fixation of bone fractures, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the device is comprised of physical components (nails, screws, end caps, etc.) made from Titanium Alloy and Stainless Steel. It is a hardware medical device for orthopedic fixation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the intramedullary fixation of fractures of the femur and tibia. This is a surgical procedure performed directly on the patient's body to stabilize broken bones.
- Device Description: The device description details the physical components of the nails, screws, and end caps, all of which are implants designed for surgical insertion.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The antegrade femoral nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures and tumor resections, Supracondylar fractures, including those with severe comminution and intra articular extension, Ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and malunions, and fractures resulting from osteoporosis.
The retrograde femoral nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures and tumor resections. Supracondylar fractures, including those with severe comminution and intra articular extension, Ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions, and fractures resulting from osteoporosis.
The tibial nail system is intended to provide temporary stabilization of various types of fractures, malunions, and nonunions of the tibia. The tibial nail system is indicated for long bone fracture fixation of tibial fractures, which may include the following: traverse, oblique, spiral, segmental and comminuted fractures with bone loss and bone transport; open and closed fractures; pathologic fractures; pseudarthrosis of the tibial shaft; nonunions, malunions, metaphyseal and epiphyseal fractures.
The trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures associated with shaft fractures pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral fractures, proximal and distal non-unions and malunions and revisions procedures.
The ES trochanteric nail is intended to treat stable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Arthrex Intramedullary Nails are comprised of Femoral, Tibial, and Trochanteric Nail Systems.
The proposed Arthrex Femoral Nail System is comprised of femoral nails (antegrade, retrograde, supracondylar retrograde), proximal and distal locking screws, end caps, spacer, and washers. All retrograde nails are threaded on the distal end to accept an end cap. The proximal and distal locking screws are comprised of fully threaded, cancellous or cortical screws and partially threaded cancellous screws. The Arthrex Femoral Nail System is manufactured from Titanium Alloy (Ti-6AL-4V ELI conforming to ASTM F136). The Arthrex Femoral Nail System is sold sterile and is single-use.
The proposed Arthrex Tibial Nail System is comprised of tibial nails, proximal and distal locking screws, end caps, and spacer of varying lengths and diameters. The tibial nail contains slots to accept the locking screws. The proximal and distal locking and blocking screws are comprised of fully threaded, cortical screws and partially threaded cannulated cancellous screws. The end caps are designed to prevent bony in-growth in the distal portion of the nail implant. The spacer is provided for proximal locking. The Arthrex Tibial Nail System is manufactured from Titanium Alloy (Ti-6AL-4V ELI confirming to ASTM F136). The Arthrex Tibial Nail System is sold sterile and single-use.
The proposed Arthrex Trochanteric Nail System is comprised of trochanteric nails (short, ES [Extended Short], and long), proximal and distal locking screws, and end caps. The trochanteric nails have slots to accept distal and proximal screws. The proximal end of the nail is threaded to accept an end cap. The Arthrex Trochanteric Nail System (nails, screws, and end caps) is manufactured from Titanium Alloy (Ti-6AL-4V ELI conforming to ASTM F136) and Stainless Steel (316LVM conforming to ASTM F138).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, tibia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Arthrex conducted packaging validation and 5-year accelerated aging shelf-life testing to demonstrate that the packaging configurations are capable of maintaining and protecting the product and sterility of the device throughout the shipping and handling environment. The proposed packaging configurations met all the packaging testing acceptance criteria in conformance to ISO 11607 and applicable standards.
MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
Bacterial Endotoxins Test (BET) was performed on the Arthrex Intramedullary Nails utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14. The testing conducted demonstrates that the sterile devices within the Arthrex Tibial Nail System meet pyrogen limit specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K133081, K202099, K141228, K132005, K130625, K123569, K103533, K070444, K021008
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 17, 2023
Arthrex, Inc. Stacy Valdez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K230257
Trade/Device Name: Arthrex Intramedullary Nails Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: June 13, 2023 Received: June 15, 2023
Dear Stacy Valdez:
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
1
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 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 mediation-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,
Image /page/1/Picture/5 description: The image shows a digitally signed document by Thomas McNamara. The document is signed on July 17, 2023, at 14:14:03. The document is for Farzana Sharmin, Ph.D., Assistant Director, DHT6A: Division of Joint Arthroplasty Devices, OHT6: Office of Orthopedic Devices, Office of Product Evaluation and Quality, and Center for Devices and Radiological Health.
Enclosure
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Indications for Use
510(k) Number (if known) K230257
Device Name Arthrex Intramedullary Nails
Indications for Use (Describe)
The antegrade femoral nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures and tumor resections, Supracondylar fractures, including those with severe comminution and intra articular extension, Ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and malunions, and fractures resulting from osteoporosis.
The retrograde femoral nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures and tumor resections. Supracondylar fractures, including those with severe comminution and intra articular extension, Ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions, and fractures resulting from osteoporosis.
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:
Department of Health and Human Services Food and Drug 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
Indications for Use
510(k) Number (if known) K230257
Device Name Arthrex Intramedullary Nails
Indications for Use (Describe)
The tibial nail system is intended to provide temporary stabilization of various types of fractures, malunions, and nonunions of the tibia. The tibial nail system is indicated for long bone fracture fixation of tibial fractures, which may include the following: traverse, oblique, spiral, segmental and comminuted fractures with bone loss and bone transport; open and closed fractures; pathologic fractures; pseudarthrosis of the tibial shaft; nonunions, malunions, metaphyseal and epiphyseal 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) |
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 Drug 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."
4
Indications for Use
510(k) Number (if known) K230257
Device Name Arthrex Intramedullary Nails
Indications for Use (Describe)
The trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures associated with shaft fractures pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral fractures, proximal and distal non-unions and malunions and revisions procedures.
The ES trochanteric nail is intended to treat stable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures.
- | 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:
Department of Health and Human Services Food and Drug 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."
5
510(k) Summary
| Date Prepared | 07/14/2023 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Stacy Valdez |
| Senior Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 72010 | |
| Stacy.valdez@arthrex.com | |
| Name of Device | Arthrex Intramedullary Nails |
| Common Name | Rod, Fixation, Intramedullary and Accessories |
| Product Code | HSB |
| Classification Name | 21 CFR 888.3020: Intramedullary Fixation Rod |
| Regulatory Class | II |
| Primary Predicate Device | K133081: AOS Intramedullary Nail |
| Additional Predicate Device(s) | K202099: AOS Galileo Trochanteric Nail System |
| K141228: AOS Antegrade Femoral Nail System | |
| K132005: AOS Retrograde Femoral Nail System | |
| K130625: AOS 12 mm and 13 mm Tibial Nails | |
| K123569: AOS Antegrade Femoral Nail System | |
| K103533: AOS ES Trochanteric Nail | |
| K070444: AOS Tibial Nail | |
| K021008: Advanced Orthopaedic Solutions Trochanteric Nail | |
| Reference Device(s) | K222267: Arthrex 2.4 mm Volar Distal Radius Plate System |
| K221031: Arthrex DualCompression Hindfoot Fusion Nail System | |
| K213837: Arthrex Ankle Fracture System | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain |
| clearance for the Arthrex Intramedullary Nails. | |
| Device Description | The Arthrex Intramedullary Nails are comprised of Femoral, Tibial, and |
| Trochanteric Nail Systems. |
The proposed Arthrex Femoral Nail System is comprised of femoral nails
(antegrade, retrograde, supracondylar retrograde), proximal and distal
locking screws, end caps, spacer, and washers. All retrograde nails are
threaded on the distal end to accept an end cap. The proximal and distal
locking screws are comprised of fully threaded, cancellous or cortical
screws and partially threaded cancellous screws. The Arthrex Femoral
Nail System is manufactured from Titanium Alloy (Ti-6AL-4V ELI
conforming to ASTM F136). The Arthrex Femoral Nail System is sold
sterile and is single-use.
The proposed Arthrex Tibial Nail System is comprised of tibial nails,
proximal and distal locking screws, end caps, and spacer of varying
lengths and diameters. The tibial nail contains slots to accept the locking
screws. The proximal and distal locking and blocking screws are
comprised of fully threaded, cortical screws and partially threaded
cannulated cancellous screws. The end caps are designed to prevent
bony in-growth in the distal portion of the nail implant. The spacer is
provided for proximal locking. The Arthrex Tibial Nail System is
manufactured from Titanium Alloy (Ti-6AL-4V ELI confirming to ASTM
F136). The Arthrex Tibial Nail System is sold sterile and single-use. |
| | The proposed Arthrex Trochanteric Nail System is comprised of
trochanteric nails (short, ES [Extended Short], and long), proximal and
distal locking screws, and end caps. The trochanteric nails have slots to
accept distal and proximal screws. The proximal end of the nail is
threaded to accept an end cap. The Arthrex Trochanteric Nail System
(nails, screws, and end caps) is manufactured from Titanium Alloy (Ti-
6AL-4V ELI conforming to ASTM F136) and Stainless Steel (316LVM
conforming to ASTM F138). |
| Indications for Use | The antegrade femoral nail is intended for use in intramedullary fixation
of fractures of the femur to include the following: Open and closed
femoral fractures, Pseudoarthrosis and correction osteotomy,
Pathologic fractures, impending pathologic fractures and tumor
resections, Supracondylar fractures, including those with severe
comminution and intra articular extension, Ipsilateral femur fractures,
bone lengthening, fractures proximal to a total knee arthroplasty or
prosthesis, fractures distal to a hip joint, nonunions and malunions, and
fractures resulting from osteoporosis. |
| | The retrograde femoral nail is intended for use in intramedullary fixation
of fractures of the femur to include the following: Open and closed
femoral fractures, Pseudoarthrosis and correction osteotomy,
Pathologic fractures, impending pathologic fractures and tumor
resections, Supracondylar fractures, including those with severe
comminution and intra articular extension, Ipsilateral femur fractures,
bone lengthening, fractures proximal to a total knee arthroplasty or
prosthesis, fractures distal to a hip joint, nonunions and malunions, and
fractures resulting from osteoporosis. |
| | The tibial nail system intended to provide temporary stabilization of
various types of fractures, malunions, and nonunions of the tibia. The
tibial nail system is indicated for long bone fracture fixation of tibial
fractures, which may include the following: traverse, oblique, spiral,
segmental and comminuted fractures; fractures with bone loss and bone
transport; open and closed fractures, pathologic fractures; corrective
osteotomies; pseudarthrosis of the tibial shaft; nonunions, malunions,
metaphyseal and epiphyseal fractures. |
| | The trochanteric nail is intended to treat stable and unstable proximal
fractures of the femur including peritrochanteric, intertrochanteric and
high subtrochanteric fractures and combinations of these fractures. The
long trochanteric nail is additionally indicated for subtrochanteric
fractures, peritrochanteric fractures associated with shaft fractures,
pathologic fractures (including prophylactic use) in osteoporotic bone of
the trochanteric and diaphyseal areas, long subtrochanteric fracture,
ipsilateral femoral fractures, proximal and distal non-unions and
malunions and revisions procedures. |
| | The ES trochanteric nail is intended to treat stable and unstable
proximal fractures of the femur including peritrochanteric,
intertrochanteric and high subtrochanteric fractures and combinations
of these fractures. |
| Performance Data | Arthrex conducted packaging validation and 5-year accelerated aging |
| | shelf-life testing to demonstrate that the packaging configurations are
capable of maintaining and protecting the product and sterility of the
device throughout the shipping and handling environment. The
proposed packaging configurations met all the packaging testing
acceptance criteria in conformance to ISO 11607 and applicable
standards.
MRI force, torque, and image artifact testing were conducted in
accordance with FDA guidance Testing and Labeling Medical Devices for
Safety in the Magnetic Resonance (MR) Environment, ASTM F2052
Standard Test Method for Measurement of Magnetically Induced
Displacement Force on Medical Devices in the Magnetic Resonance
Environment, ASTM F2119 Standard Test Method for Evaluation of MR
Image Artifacts from Passive Implants, ASTM F2182 Standard Test
Method for Measurement of Measurement of Radio Frequency Induced
Heating Near Passive Implants During Magnetic Resonance Imaging and
ASTM F2213 Standard Test Method for Measurement of Magnetically
Induced Torque on Medical Devices in the Magnetic Resonance
Environment. |
| | Bacterial Endotoxins Test (BET) was performed on the Arthrex
Intramedullary Nails utilizing the Kinetic Chromogenic Method in
accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP ,
EP 2.6.14. The testing conducted demonstrates that the sterile devices
within the Arthrex Tibial Nail System meet pyrogen limit specifications. |
| Technological Comparison | The Arthrex Femoral Nail System was previously cleared as the AOS
Femoral Nail System under K141228, K133081, K132005, and K123569.
The Arthrex Femoral Nail System is substantially equivalent to the
predicate devices cleared under K133081 in which the intended use,
fundamental scientific technology, design, material, sterility, and shelf-
life are identical. |
| | The Arthrex Tibial Nail System was previously cleared as the AOS Tibial
Nail System under K070444, K130625, and K133081. The Arthrex Tibial
Nail System is substantially equivalent to the predicate devices cleared
under K133081 in which the intended use, fundamental scientific
technology, design, material, sterility, and shelf-life are identical. |
| | The Arthrex Trochanteric Nail System was previously cleared as the AOS
Trochanteric Nail System under K012190, K021008, K070444, K103533,
K120148, K123569, K133081, and K202099. The Arthrex Trochanteric
Nail System is substantially equivalent to the predicate devices cleared
under K133081 in which the intended use, fundamental scientific
technology, design, material, sterility, and shelf-life are identical. |
| | The Arthrex Femoral Nail System (sterile nails) are offered larger in
proximal diameter and shorter/longer lengths than the primary
predicate AOS Intramedullary Nail, K133081. The larger proximal
diameter and shorter/longer lengths of the sterile nails were originally
cleared as non-sterile under additional predicate devices AOS Antegrade
Femoral Nail System, K123569 and AOS Retrograde Femoral Nail
System, K132005. |
| | The Arthrex Trochanteric Nail System (sterile nails) are longer in length
than the primary predicate AOS Intramedullary Nail, K133081. The
longer length of the sterile nails were originally cleared as non-sterile
under additional predicate device AOS Galileo Trochanteric Nail System,
K202099. |
| | The Arthrex Tibial Nail System (sterile screws) are offered in shorter and
longer lengths than the primary predicate AOS Intramedullary Nail,
K133081. The shorter and longer lengths of the sterile screws were
originally cleared as non-sterile under additional predicate device AOS
Tibial Nail, K070444. |
| | The Arthrex Trochanteric Nail System (sterile screws) are offered in
shorter and longer lengths than the primary predicate AOS
Intramedullary Nail, K133081. The shorter and longer lengths of the
sterile screws were originally cleared as non-sterile under additional
predicate device Advanced Orthopaedic Solutions Trochanteric Nail,
K021008. |
| | The Arthrex Tibial Nail System (sterile end cap) is a larger size than the
primary predicate AOS Intramedullary Nail, K130081. However, the
larger size was originally cleared as non-sterile under additional
predicate device AOS Antegrade Femoral Nail System, K123569. |
| | The sterile packaging for the Arthrex Intramedullary Nails is changing to
a double nylon/nylon pouch (for the nails), a double PETG blister tray
with Tyvek lidding (for the screws, end caps, and spacer), and a double
PETG blister tray with Tyvek lidding or double poly/Tyvek pouch (for the
washers). These are existing packaging configurations cleared under
reference device Arthrex 2.4 mm Volar Distal Radius Plate System,
K222267 and Arthrex Ankle Fracture System, K213837. |
| | The Arthrex Intramedullary Nails were evaluated for MR Conditional
labeling. The primary predicate AOS Intramedullary Nail, K133081 was
not evaluated for MR Safety. |
| | The Arthrex Intramedullary Nails is substantially equivalent to the
predicate devices cleared under K133081, with minor modifications with
no change to the intended use, design, or function. Any differences
between the Arthrex Intramedullary Nails and the predicate devices are
considered minor and do not raise different questions of safety or
effectiveness. |
| Conclusion | The Arthrex Intramedullary Nails are substantially equivalent to the
predicate devices cleared under K133081 in which the basic design
features and intended use are the same. Any differences between the
Arthrex Intramedullary Nails and the predicate devices are considered
minor and do not raise different questions of safety or effectiveness.
Based on the indications for use, technological characteristics, and the
summary of data submitted, Arthrex Inc. has determined that the
proposed device is substantially equivalent to the currently marketed
predicate devices. |
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