(28 days)
No
The summary describes a mechanical implant (locking plate system) for bone fracture fixation and does not mention any software, algorithms, or AI/ML capabilities. The modifications are related to adding new plate sizes.
Yes
The device is described as an "AxSOS™ Locking Plate System" intended for "long bone fracture fixation," which clearly indicates its use in treating a medical condition.
No
Explanation: The device description and intended use clearly state that this is a surgical implant (locking plate system) for fracture fixation, not a device used for diagnosis.
No
The device description clearly states it is a "Locking Plate System" and describes physical plates for bone fixation, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in long bone fracture fixation." This describes a surgical implant used in vivo (within the body) to stabilize fractures.
- Device Description: The description details "locking plates" and their use in fixing fractures of the humerus, tibia, and femur. This is consistent with a surgical implant.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Reagents, calibrators, or controls.
IVDs are devices used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is clearly designed for direct surgical implantation and fixation of bones.
N/A
Intended Use / Indications for Use
The AxSOS™ Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia and femur.
Product codes
87 HRS
Device Description
This Special 510(k) submission is a line extension to address modifications made to the AxSOSTM Locking Plate System which was cleared in K061012. This line extension is to add humeral long plates to the existing size range of the AxSOSTM Locking Plate System. These monoaxial long plates will be known as AxSOSTM Proximal Lateral Humerus TS (Threaded Shaft) Long Plates and will be available in 6 length sizes in left and right configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus, tibia and femur
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
Risk analysis was performed according to the requirements of ISO 14971:2007 "Medical Devices-Application of risk management to medical devices." Records of the risk analysis process are retained in the design history file. Testing has been performed to demonstrate equivalence of the subject device to its predicate device. The testing included static strength testing using combined axial and torsional loading as well as fatigue strength testing by way of evaluating median fatigue limits and dynamic stiffness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
110476 # '।
| 510(k) Summary of Safety and Effectiveness
| AxSOS™ Locking Plate System | MAR 18 2011 | |
|---|---|---|
| Proprietary Name: | AxSOS™ Locking Plate System | |
| Common Name: | Bone plates | |
| Classification Name and Reference: | Single/multiple component metallic bone fixation appliances and | |
| accessories, 21 CFR §888.3030 | ||
| Regulatory Class: | Class II | |
| Product Codes: | 87 HRS: Plate, Fixation, Bone | |
| Predicate Devices: | AxSOS™ Locking Plate System | |
| For Information contact: | Estela Celi, Regulatory Affairs Associate | |
| Howmedica Osteonics Corp. | ||
| 325 Corporate Drive | ||
| Mahwah, NJ 07430 | ||
| Phone: (201) 831-6461 Fax: (201) 831-6038 | ||
| estela.celi@stryker.com | ||
| Date Prepared: | February 16th, 2011 |
Description
ﺰ
This Special 510(k) submission is a line extension to address modifications made to the AxSOSTM Locking Plate System which was cleared in K061012. This line extension is to add humeral long plates to the existing size range of the AxSOSTM Locking Plate System. These monoaxial long plates will be known as AxSOSTM Proximal Lateral Humerus TS (Threaded Shaft) Long Plates and will be available in 6 length sizes in left and right configurations.
Intended Use
The AxSOS™ Proximal Lateral Humerus TS Long Plates line extension does not alter the intended use of the predicate AxSOS™ Locking Plate System as cleared in K061012. The indications for use for the subject plates are provided below.
Indications
The AxSOS™ Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia and femur.
1
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Substantial Equivalence:
The AxSOS™ Proximal Lateral Humerus TS Long Plates are substantially equivalent to the AxSOS™ Proximal Lateral Humerus TS Plates of the AxSOSTM Locking Plate System cleared under K061012 in regards to intended use, design, materials, and operational principles as a bone fixation device.
| AxSOS TM Locked Plating Comparison of Subject to Predicate | ||
|---|---|---|
| Subject Device | ||
| AxSOSTM Proximal Lateral | ||
| Humerus TS Long Plates | Predicate Device | |
| AxSOSTM Proximal Lateral | ||
| Humerus TS Plates | ||
| 510(k) | Pending | K061012 |
| Intended Use | Fractures of the Proximal Humerus | Fractures of the Proximal Humerus |
| Design | Monoaxial Plates | Monoaxial Plates |
| Material | Stainless Steel | Stainless Steel |
| Plate Sizes | 6 lengths/10-20 hole plates | 3 lengths/3-8 hole plates |
Summary of Non-Clinical Testing and Evaluation
Risk analysis was performed according to the requirements of ISO 14971:2007 "Medical Devices-Application of risk management to medical devices." Records of the risk analysis process are retained in the design history file. Testing has been performed to demonstrate equivalence of the subject device to its predicate device. The testing included static strength testing using combined axial and torsional loading as well as fatigue strength testing by way of evaluating median fatigue limits and dynamic stiffness.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Stryker Corp. % Howmedica Osteonics Corp. Ms. Estela Celi 325 Corporate Drive Mahwah, New Jersey 07430
MAR 1 8 2011
Re: K110476
Trade/Device Name: AxSOS™ 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 Dated: February 16, 2011 Received: February 18, 2011
Dear Ms. Celi:
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
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Page 2 - Ms. Estela Celi
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
A. B. A
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX E-1
Indication for Use Statement
Indications for Use
510(k) Number (if known): K110476
Device Name: AxSOS™ Proximal Lateral Humerus TS Long Plates
Indications for Use:
The AxSOSTM Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia and femur.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Mulletron
(Division Sign-Off) (Division of Surgical, Orthopedic, Divisionative Devices
510(k) Number