(122 days)
Not Found
No
The document describes a mechanical device (locking plates and cable plugs) for fracture fixation and mentions only mechanical and functional testing, with no indication of software, image processing, or AI/ML components.
Yes
The device is described as "long bone fracture fixation," indicating its use in treating a medical condition directly.
No.
The device is described as a plating system intended for long bone fracture fixation, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "Locked Plating System" and mentions "Cable Plugs," which are physical components used in surgical procedures for bone fixation. This indicates a hardware device, not software only.
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 to stabilize broken bones within the body.
- Device Description: The device is described as "AxSOS® SPS Monoaxial Locking Plates" and "AxSOS® Cable Plug," which are components of a "Locked Plating System." These are physical implants.
- 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 screening.
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 AxSOS® SPS Monoaxial Locking Plates in the Stryker Locked Plating system are intended for use in long bone fracture fixation. The AxSOS® SPS Monoaxial Locking Plates are indicated for fixation of long bone fractures including the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.
Product codes (comma separated list FDA assigned to the subject device)
87 HRS, 87 HWC
Device Description
This Special 510(k) submission is intended to address modifications to the Stryker Locked Plating System. This line extension is to add additional styles of Cable Plugs. The AxSOS® Cable Plug is being modified as part of a line extension of the Stryker Locked Plating System. The AxSOS® Locked Plating System currently contains 4mm and 5mm Cable Plugs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone fractures including the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject AxSOS® Stryker Locked Plating System to the predicate device K050512, K060514, K061012, and K060798.
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.
K050512, K060514, K061012, K060798
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.
Not Found
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
510(k) Summary of Safety and Effectiveness: AxSOS® Stryker Locked Plating System Line Extension of Cable Plugs
Submission Information
Name and Address of the Sponsor of the 510(k) Submission
For Information contact:
Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430
NOV 2 0 2009
Melissa A. Matarese, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5116 Fax: (201) 831-4116
Date Summary Prepared:
Device Identification Proprietary Name:
Common Name: Classification Name and Reference:
Device Product Code:
July 15, 2009
AxSOS® Stryker Locked Plating System Line Extension of Cable Plugs Bone plates and screws Single/multiple component metallic bone fixation appliances and accessories, 21 CFR 888.3030
87 HRS: Plate, Fixation, Bone 87 HWC: Screw, Fixation, Bone
Description:
This Special 510(k) submission is intended to address modifications to the Stryker Locked Plating System. This line extension is to add additional styles of Cable Plugs. The AxSOS® Cable Plug is being modified as part of a line extension of the Stryker Locked Plating System. The AxSOS® Locked Plating System currently contains 4mm and 5mm Cable Plugs.
Intended Use:
Stryker Locked Plating System Line Extension of Cable Plugs The AxSOS® modifications do not alter the intended use of the predicate systems as cleared in their respective premarket notifications. The indications for use for the subject plates are provided below.
Indications for Use:
The AxSOS® SPS Monoaxial Locking Plates in the Stryker Locked Plating system are intended for use in long bone fracture fixation. The AxSOS® SPS Monoaxial Locking
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Plates are indicated for fixation of long bone fractures including the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.
Statement of Technological Comparison:
The subject and predicate devices are made from Stainless Steel. Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject AxSOS® Stryker Locked Plating System to the predicate device K050512, K060514, K061012, and K060798. .
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corporation c/o Ms. Melissa Matarese Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430
NOV 20 2009
Re: K092178
Trade/Device Name: AxSOS® Locked Plating System Line Extension of Cable Plugs 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: October 30, 2009 Received: November 5, 2009
Dear Ms. Matarese:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Melissa Matarese
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Jonetta Jr
Image /page/3/Picture/7 description: In this image, there is a close-up of a document with some text. The text includes the name "Mark N. Mel" followed by the title "Director Div". The text also includes the words "and Restora" and "Office of De".
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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510(k) Number (if known):
Device Name: AxSOS® Locked Plating System Line Extension of Cable Plugs
Indications For Use:
The AxSOS® SPS Monoaxial Locking Plates in the Stryker Locked Plating system are intended for use in long bone fracture fixation. The AxSOS® SPS Monoaxial Locking Plates are indicated for fixation of long bone fractures including fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia, and the distal femur.
Prescription Use X (Part 21 CFR 801
Subpart D)
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Soutte
Page 1 of 1
(Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092178