(71 days)
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.
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.
The provided document describes a 510(k) submission for a medical device called the "AxSOS® Locked Plating System Line Extension of 5mm Locking Inserts." This submission focuses on modifications made to existing locking inserts within the system to improve manufacturability and fit.
The information primarily discusses the mechanical and functional testing performed to demonstrate that the modified device is substantially equivalent to its predicate devices. It does not present acceptance criteria or a study related to human reader performance, algorithms, or ground truth derived from expert consensus, pathology, or outcomes data in the way typically found for diagnostic or AI-driven devices.
Therefore, many of the requested sections about acceptance criteria and study details for an AI/diagnostic device are not applicable or cannot be extracted from this document.
Here's the information that can be extracted or derived based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional and Mechanical Equivalence to Predicate Device | Demonstrated comparable mechanical & functional properties to the predicate device (K050512) through testing. Specific quantitative criteria and performance metrics are not detailed in this summary. |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "testing was conducted" for various mechanical tests but does not provide specific sample sizes (e.g., number of inserts or constructs tested).
- Data Provenance: Not applicable in the context of clinical data or patient data. The testing is described as mechanical and functional in nature, likely performed in an engineering lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The "ground truth" in this context is based on engineering measurements and established mechanical testing standards, not clinical expert consensus.
4. Adjudication method for the test set
- Not applicable. This type of mechanical testing generally relies on direct measurement and comparison to predefined engineering specifications or predicate performance, rather than expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a submission for a mechanical implant (bone fixation system), not a diagnostic device or AI system that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithmic device. The "standalone" performance here refers to the mechanical performance of the device components themselves.
7. The type of ground truth used
- Ground Truth: The "ground truth" for the performance claims is based on established engineering principles and mechanical testing standards comparing the modified device's performance directly to its predicate device. This includes measurements from tests like Construct Torsion, Insertion Force, Cantilever Bending, Push-Out, and Construct Fatigue.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of an AI/machine learning model for this device. The development process involved design modifications and subsequent mechanical testing.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set mentioned for an AI/ML model.
{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 Sponsorof the 510(k) Submission: | Howmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430 | APR 30 2010 |
| For Information contact: | Melissa A. Matarese, Regulatory Affairs AssociateHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5116Fax: (201) 831-4116 | |
| Date Summary Prepared: | April 27, 2010 | |
| Device Identification | ||
| Proprietary Name: | AxSOS® Locked Plating System Line Extension of5mm Locking Inserts | |
| Common Name: | Bone plates and screws | |
| Classification Name and Reference: | Single/multiple component metallic bone fixationappliances and accessories, 21 CFR §888.3030Smooth or Threaded metallic bone fixation fastener21 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}------------------------------------------------
$$
\pi/\omega \approx 57000\lambda$$
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
§ 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.