(51 days)
No
The device description and performance studies focus on the mechanical properties and design of bone plates and screws for fracture fixation, with no mention of AI or ML.
Yes
The device is intended for long bone fracture fixation, non-unions, malunions, and osteotomies, which are therapeutic interventions.
No
The device is described as a "Ti Locking Plate System" intended for "long bone fracture fixation," including plates and screws. This indicates it is a therapeutic device used for surgical repair, not for diagnosing conditions.
No
The device description explicitly details physical components such as plates and screws made of titanium, intended for surgical implantation. It also mentions non-clinical laboratory testing performed on these physical components. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "long bone fracture fixation," addressing various types of fractures, non-unions, malunions, osteotomies, and periprosthetic fractures. This is a surgical intervention to stabilize bones.
- Device Description: The device is described as a "Locking Plate System" consisting of plates and screws made of titanium. These are physical implants used to hold bone fragments together.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not interact with bodily samples for diagnostic purposes.
- Performance Studies: The performance studies described are mechanical tests on the plates and screws (ASTM standards for metallic bone plates and screws), not studies evaluating the accuracy or performance of a diagnostic test.
The AxSOS 3 Ti Locking Plate System is a surgical implant used for orthopedic procedures, not a diagnostic device.
N/A
Intended Use / Indications for Use
The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation. Indications include:
- Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures .
- . Non-unions and malunions
- Normal and osteopenic bone .
- . Osteotomies
- Periprosthetic fractures of the femur and proximal tibia .
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to market additional plates and screws within the AxSOS 3 Ti Locking Plate System. The AxSOS 3 Ti Locking Plate System includes anatomically contoured monoaxial locking plates. The 5.0mm System consists of the Distal Lateral Femur Plate (K123964). The 4.0mm System comprises the Proximal Lateral Tibia Plate (K123964) as well as the subject devices being the Distal Anterolateral Tibia Plate, the Distal Medial Tibia Plate and the Proximal Medial Tibia Plate. The system includes four (4) types of screws available in various diameter and thread length: locking, cortical, cancellous (K123964 & K133440) as well as the subject periprosthetic screws. The plates have been designed with holes that can accommodate either a locking or non-locking screw both at the peri-articular end and along the shaft of the plates also have an oblong hole located at the metaphyseal junction used to aid in positioning. The subject components will be available sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bone, femur, tibia
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical laboratory testing was performed on the worst case subject plates to determine substantial equivalence. The following testing was performed:
- "Standard Specification and Test Method for Metallic Bone Plates" as per ASTM F382-. 99 (reapproved 2008)
- "Standard Specification and Test Methods for Metallic Medical Bone Screws as per . ASTM F 543-07"
Testing demonstrated that the subject plates are substantially equivalent to the currently marketed predicate devices.
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.
K013248, K050646, K083032, K041533
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
t +
510(k) Summary
| Proprietary Name: | AxSOS 3 Ti Locking Plate System | JUN 20 2014 |
|---|---|---|
| Common Name: | Bone Plates | |
| Bone Screws | ||
| Classification Name and Reference: | Single/multiple component metallic bone fixation appliance and accessories 21 CFR §888.3030 | |
| Smooth or threaded metallic bone fixation fastener | ||
| 21 CFR §888.3040 | ||
| Regulatory Class: | Class II | |
| Product Codes: | HRS: Plate, Fixation, Bone | |
| HWC: Screw, Fixation, Bone | ||
| Sponsor: | Stryker Trauma AG | |
| Contact Person: | Elijah N. Wreh | |
| Regulatory Affairs Specialist | ||
| 325 Corporate Drive | ||
| Mahwah, NJ 07430 | ||
| elijah.wreh@stryker.com | ||
| Phone: 201-831-5691 | ||
| Fax: 201-831-4691 |
Description
Date Prepared:
This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to market additional plates and screws within the AxSOS 3 Ti Locking Plate System. The AxSOS 3 Ti Locking Plate System includes anatomically contoured monoaxial locking plates. The 5.0mm System consists of the Distal Lateral Femur Plate (K123964). The 4.0mm System comprises the Proximal Lateral Tibia Plate (K123964) as well as the subject devices being the Distal Anterolateral Tibia Plate, the Distal Medial Tibia Plate and the Proximal Medial Tibia Plate. The system includes four (4) types of screws available in various diameter and thread length: locking, cortical, cancellous (K123964 & K133440) as well as the subject periprosthetic screws. The plates have been designed with holes that can accommodate either a locking or non-locking screw both at the peri-articular end and along the shaft of the plates also have an
April 29, 2014
1
oblong hole located at the metaphyseal junction used to aid in positioning. The subject
components will be available sterile and non-sterile.
Intended Use
The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation.
Indications for Use
The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation. Indications include:
- Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures .
- . Non-unions and malunions
- Normal and osteopenic bone .
- . Osteotomies
- Periprosthetic fractures of the femur and proximal tibia .
Summary of Technology
The device comparison showed that the subject device is substantially equivalent in intended use,
design, materials and operational principles to the following predicate devices:
- . Synthes LCP Distal Tibia Plates (K013248)
- Synthes (USA) 3.5/4.5MM LCP Medial Proximal Tibia Plates (K050646) .
- Peri-Loc Bone Plating and Screw System (K083032) .
- . Synthes Peri-Prosthetic Screws (K041533)
The subject plates and screws are substantially equivalent to the predicate devices in regards to
intended use, design, materials, and operational principles for long bone fracture fixation.
Non-Clinical Test
Non-clinical laboratory testing was performed on the worst case subject plates to determine
substantial equivalence. The following testing was performed:
- "Standard Specification and Test Method for Metallic Bone Plates" as per ASTM F382-. 99 (reapproved 2008)
- "Standard Specification and Test Methods for Metallic Medical Bone Screws as per . ASTM F 543-07"
Testing demonstrated that the subject plates are substantially equivalent to the currently
marketed predicate devices.
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The subject AxSOS 3 Ti Locking Plate System is substantially equivalent to the predicate
devices identified throughout this submission.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle with three overlapping wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Stryker Trauma AG Mr. Elijah Wreh Regulatory Affair Specialist 325 Corporate Drive Mahwah. New Jersey 07430
Re: K141121
Trade/Device Name: AxSOS 3 Ti Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: April 29, 2014 Received: May 01, 2014
June 20, 2014
Dear Mr. Wreh:
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. 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 (reporting of medical
3
Page 2 - Mr. Elijah Wreh
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -A
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | Form Approved: OMB No. 0910-0120 |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| 510(k) Number ( if known ) | K141121 |
| Device Name | AxSOS 3 Ti Locking Plate System |
| Indications for Use ( Describe ) | The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation. |
| Indications include: | |
| • Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures | |
| • Non-unions and malunions | |
| • Normal and osteopenic bone | |
| • Osteotomies | |
| • Periprosthetic fractures of the femur and proximal tibia | |
| 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) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Elizabeth L. Frank -S
Division of Orthopedic Devices
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
Food and Drug Administration Offica of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@ida.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."
.