(26 days)
No
The document describes a mechanical device (bone plates and inserts) and does not mention any software, algorithms, or AI/ML terms.
No
The device, SPS Monoaxial Locking Plates, is intended for long bone fracture fixation, which is a structural support function rather than an active therapeutic intervention to treat a disease or condition.
No
The device, SPS Monoaxial Locking Plates, is described as being "intended for use in long bone fracture fixation." This indicates a therapeutic or reparative function, not a diagnostic one. There is no mention of it being used to identify, detect, or analyze medical conditions.
No
The device description explicitly states it is a "Locked Plating System" and discusses "Locking Inserts," which are physical components used in bone fracture fixation. This indicates a hardware-based medical device, not a software-only one.
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 bone fractures within the body.
- Device Description: The device is described as "SPS Monoaxial Locking Plates" and "AxSOS® Locking Insert," which are components of a "Locked Plating System." These are physical implants.
- 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. The provided text does not mention any testing of biological samples or diagnostic purposes.
Therefore, the device described is a surgical implant for fracture fixation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AxSOS® Locked Plating System Line Extension of 3mm Locking Insert 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.
The SPS Monoaxial Locking Plates in the Stryker Locked Plating System are intented for use in long bone fracture fixation. The 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.
Product codes
HRS, HWC
Device Description
This Special 510(k) submission is intended to address modifications to the predicate Stryker Locking Inserts.
The AxSOS® Locking Insert is being modified as part of a line extension of the AxSOS® Locked Plating System. The AxSOS® Locked Plating System contains 3mm Locking Inserts to which changes are being made.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.
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
Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject AxSOS® System to the predicate device K050512, K060514, K060798, and K061012.
Key Metrics
Not Found
Predicate Device(s)
K050512, K060514, K060798, and K061012
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
KO92419
AxSOS® Locked Plating System Line Extension of 3mm Locking Inserts
Special 510(k)
510(k) Summary of Safety and Effectiveness: AxSOS® Locked Plating System Line Extension of 3mm Locking Inserts
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
For Information contact:
Date Summary Prepared:
Device Identification Proprietary Name:
Common Name: Classification Name and Reference:
Device Product Code:
SEP - 1 2009
Howmedica Osteonics Corp 325 Corporate Drive Mahwah. NJ 07430
Melissa A. Matarese, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate. Drive Mahwah, NJ 07430 Phone: (201) 831-5116 Fax: (201) 831-4116
August 31, 2009
AxSOS® Locked Plating System Line Extension of 3mm Locking Inserts Bone plates and screws Single/multiple component metallic bone fixation appliances and accessories, 21 CFR 888.3030 Smooth or Threaded metallic bone fixation fastener, 21 CFR $888.3040 87 HRS: Plate, Fixation, Bone
87 HWC: Screw, Fixation, Bone
Description:
This Special 510(k) submission is intended to address modifications to the predicate Stryker Locking Inserts.
The AxSOS® Locking Insert is being modified as part of a line extension of the AxSOS® Locked Plating System. The AxSOS® Locked Plating System contains 3mm Locking Inserts to which changes are being made.
Intended Use:
The AxSOS® Locked Plating System Line Extension of 3mm Locking Insert 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.
2092419 Page 1/2
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Indications for Use:
The AxSOS® SPS Monoaxial Locking Plates in the Stryker Locked Plating System are intented for use in long bone fracture fixation. The 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.
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® System to the predicate device K050512, K060514, K060798, and K061012.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp. % Ms. Melissa A. Matarese Regulatory Affairs Associate 325 Corporate Drive Mahwah, NJ 07430
SEP - 1 2009
Re: K092419
Trade/Device Name: AxSOS® Locked Plating System (Line Extension of 3mm Locking Inserts) 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: August 4, 2009
Received: August 6, 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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Melissa A. Matarese
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,
Sincerely yours,
Barbara Buchm
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KO92419
Device Name: AxSOS® Locked Plating System Line Extension of 3mm Locking Inserts
Indications For Use:
The SPS Monoaxial Locking Plates in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The 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 ·
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Smitta for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092419