(25 days)
No
The document describes a mechanical plating system for bone fracture fixation and does not mention any AI or ML components or functionalities.
Yes
The device is intended for fracture fixation, which is a therapeutic intervention aimed at treating injuries.
No
Explanation: The device is a bone plating system intended for fracture fixation, which is a treatment rather than a diagnostic process. It does not mention any diagnostic capabilities.
No
The device description explicitly states it is a "Locked Plating System" and describes physical components ("4mm Locking Inserts made from stainless steel"). This indicates it is a hardware medical device, not software-only.
No, 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 a "Locked Plating System" and "Locking Inserts" made from stainless steel. These are physical components used in surgery.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
The information provided clearly indicates a surgical implant for internal fixation, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The AxSOS Locked Plating System in the Stryker Locked Plaing System are intended for use in long bone fracture fixation. The AxSOS Locked Plating System is 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 Device Desertifican. This Openal 910(x) backing Insert is heing modified as part of a line extension of the AxSOS® Locked Plating System. The AxSOS® Locked Plating System contains 4mm Locking Inserts to which changes are being made to improve manufacturability. The locking inserts are made from stainless steel per ASTM F138 and ASTM F139. The AxSOS® Locked Plating 4.0mm Locking Inserts have similar or identical and material properties to the predicate 4.0mm Locking Inserts determined substantially equivalent via 510(k) K050512.
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
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
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The following mechanical/functional testing was performed: insertion force, screw insertion, push out, torsion, bending, and fatigue. The testing demonstrated that the AxSOS® Locked Plating 4.0mm Locking Inserts met performance requirements and are as safe and effective as their predicates.
Clinical Testing: None provided as a basis for substantial equivalence
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
K110176 * 1/d
AxSOSE Locked Plating System I.Ine Extension of 4mm Locklug Inserts
Special 510(k)
FEB 15 201
510(k) Summary of Safety and Effectivencss:
AxSOS® Locked Plating System Line Extension of 4mm Locking Inserts
Sponsor
Howmedica Osteonics Corp. 325 Corporate Drive Mahwalı, NJ 07430
Contact Person
Anthony Dennis Specialist, Regulatory Affairs Howmedica Osteonics Corp. 325 Corporate Drive Mahwalı, NJ 07430 Phone: (201) 831-5804
| Date Prepared: | January 19, 2011 |
|---|---|
| Proprietary Name: | AxSOS® Locked Plating System Line Extension of 4mm Locking |
| Inserts | |
| Common Name: | Bone plates and screws |
| Classification Name: | 21 CFR §888.3030 |
| Single/multiple component metallic bone fixation appliances and | |
| accessories | |
| Classification Name: | 21 CFR §888.3040 |
| Smooth or Threaded metallic bone fixation fastener |
Legally Marketed Device to Which Substantial Equivalence is Claimed:
Howmedica Osteonics Stryker Locked Plating System: K050512
Device Description: This Special 510(k) submission is intended to address modifications to the Device Desertifican. This Openal 910(x) backing Insert is heing modified as part of a line
1
K110176 #2/d
AxSOS Locked Plating System Line Extension of 4mm Locking Inserts
Special 510(k)
extension of the AxSOS® Locked Plating System. The AxSOS® Locked Plating System contains 4mm Locking Inserts to which changes are being made to improve manufacturability. The locking inserts are made from stainless steel per ASTM F138 and ASTM F139. The AxSOS® Locked Plating 4.0mm Locking Inserts have similar or identical and material properties to the predicate 4.0mm Locking Inserts determined substantially equivalent via 510(k) K050512.
Intended Use: The AxSOS® Locked Plating System Line Extension of 4mm 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.
Indications:
The AxSOS Locked Plating System in the Stryker Locked Plating System is intended for use in long bone fracture fixation. The AxSOS Locked Plating System is 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.
Summary of Technologies: The technological characteristics (material, design, sizes, and operational principles) of the AxSOS® Locked Plating 4.0mm Locking Inserts are similar or identical to the predicate device, K050512.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The following mechanical/functional testing was performed: insertion force, screw insertion, push out, torsion, bending, and fatigue. The testing demonstrated that the AxSOS® Locked Plating 4.0mm Locking Inserts met performance requirements and are as safe and effective as their predicates.
Clinical Testing: None provided as a basis for substantial equivalence
Conclusion:
The AxSOS® Locked Plating 4.0mm Locking Inserts is substantially equivalent to the predicate devices identified in this pre-market notification.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines extending from its body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp. % Mr. Anthony Dennis 325 Corporate Drive Mahwah, New Jersey 07430
FEB 15 201
Re: K110176
Trade/Device Name: AxSOS® Locked Plating System Line Extension of 4mm 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: January 20, 2011 Received: January 21, 2011
Dear Mr. Dennis:
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.
3
Page 2 - Mr. Anthony Dennis
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 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.S. B. Rh
for
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): K | | Ol 76
Device Name: AxSOS® Locked Plating System Line Extension of 4mm Locking Inserts
Indications For Use:
The AxSOS Locked Plating System in the Stryker Locked Plaing System are intended for use in I The AxSOS Econod Plating Official in the Stystem is indicated for firstion of long long oone fracture fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia, and the distal femur.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(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)
Page 1 of 1
for M. Melkerson
(Division Sign-Off) Division of Surgical Orthopedic, and Restorative Devices
510(k) Number K110776