(71 days)
No
The document describes modifications to a mechanical implant (locking inserts for bone plates) focused on improving manufacturability and fit. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a "Locked Plating System" intended for "long bone fracture fixation," which directly implies its use in treating and healing a medical condition (fractures).
No
The device is described as a plating system for fracture fixation, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a "Locked Plating System" and describes modifications to "Locking Inserts," which are physical components used in bone fracture fixation. The performance studies also focus on mechanical properties of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "long bone fracture fixation." This is a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a "Locked Plating System" and "Locking Inserts," which are implants used to stabilize bone fractures. This is a physical device for internal fixation, not a diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly intended for surgical treatment of bone fractures, which falls under the category of therapeutic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The AxSOS® Locked Plating System of the Stryker Locked Plating System is intended for use in long bone fracture fixation. The AxSOS 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 (comma separated list FDA assigned to the subject device)
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 5mm Locking Inserts to which changes are being made to improve manufacturability. The modifications to the 5mm AxSOS® Locking Insert are to remove undefined free-form surfaces and replace them with clearly defined surfaces that mate with the plate hole geometry. The removal of these undefined free-form surfaces improves manufacturability, inspectability, and allows for a more precise fit into the plate holes. The changes are identical to the changes to the 4mm Locking Inserts cleared in K092419.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone fractures including fractures of 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)
Construct Torsion, Insertion Force, Cantilever Bending, Push-Out, and Construct Fatigue. 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.
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.
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
Image /page/0/Picture/0 description: The image shows the text "K100475 # '12". The text appears to be handwritten in black ink on a white background. The number is likely an identifier or code, and the "# '12" may indicate a sequence or item number.
510(k) Summary of Safety and Effectiveness: AxSOS® Locked Plating System Line Extension of 5mm Locking Inserts
| Submission Information | ||
|---|---|---|
| Name and Address of the Sponsor | ||
| of the 510(k) Submission: | Howmedica Osteonics Corp | |
| 325 Corporate Drive | ||
| Mahwah, NJ 07430 | APR 30 2010 | |
| For Information contact: | 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: | April 27, 2010 | |
| Device Identification | ||
| Proprietary Name: | AxSOS® Locked Plating System Line Extension of | |
| 5mm Locking Inserts | ||
| Common Name: | Bone plates and screws | |
| Classification Name and Reference: | Single/multiple component metallic bone fixation | |
| appliances and accessories, 21 CFR §888.3030 | ||
| Smooth or Threaded metallic bone fixation fastener | ||
| 21 CFR §888.3040 | ||
| Device Product Code: | 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 5mm Locking Inserts to which changes are being made to improve manufacturability. The modifications to the 5mm AxSOS® Locking Insert are to remove undefined free-form surfaces and replace them with clearly defined surfaces that mate with the plate hole geometry. The removal of these undefined free-form surfaces improves manufacturability, inspectability, and allows for a more precise fit into the plate holes. The changes are identical to the changes to the 4mm Locking Inserts cleared in K092419.
Intended Use:
The AxSOS® Locked Plating System Line Extension of 5mm 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 for Use:
1
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The AxSOS® Locked Plating System of the Stryker Locked Plating System is intended for use in long bone fracture fixation. The AxSOS 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 following testing was conducted: Construct Torsion, Insertion Force, Cantilever Bending, Push-Out, and Construct Fatigue. 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is simple and uses a black and white color scheme.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corporation % Ms. Melissa A. Matarese 325 Corporate Drive Mahwah, New Jersey 07430
APR 3 0 2010
Re: K100475
Trade/Device Name: AxSOS® Locked Plating System Line Extension of 5mm Locking Insert Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: March 31, 2010 Received: April 01, 2010
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. 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
3
Page 2 – Ms. Melissa A. Matarese
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 vours.
Barbara Buechner
Mark N. Mel 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): K100475
Device Name: AxSOS® Locked Plating System Line Extension of 5mm Locking Inserts
Indications For Use:
The AxSOS® Locked Plating System of the Stryker Locked Plating System is intended for use in long bone fracture fixation. The AxSOS 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 -------
(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
Smitta for mxn
(Division Sign-Off)
Division of Surgical Orthopedic. and Restorative Devices
510(k) Number K160475