(105 days)
Not Found
Not Found
No
The summary describes physical pins used for fixation during computer-assisted surgery and contains no mention of AI, ML, or related concepts.
No.
The device's intended use is to rigidly fixate a Tracker for computer-assisted surgical procedures, not to treat or diagnose a disease or condition.
No
The device, pins for rigid fixation of a Tracker during computer-assisted surgery, is a surgical instrument used for guidance, not for diagnosing a condition or disease. Its purpose is to physically stabilize a component for surgical navigation.
No
The device description explicitly states "Reprocessed Pins," indicating a physical hardware component. The intended use also describes "rigidly fixate a Tracker to a single bone," which requires a physical pin.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The intended use of these pins is to physically fixate a tracker to a bone during surgery. This is a mechanical function performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body).
- Lack of Diagnostic Information: The description does not mention any analysis of biological samples or the generation of diagnostic information.
Therefore, this device falls under the category of a surgical instrument or accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The pins are intended to be used to rigidly fixate a Tracker to a single bone during computer assisted surgical procedures including hip, knee, and other trauma applications. Specifically:
- Navigation and Ortholock Ex-Pins: The intended use of the Stryker OrthoLock Ex-Pins is to rigidly fixate a Tracker to the bone undergoing treatment. The Stryker OrthoLock Ex-Pins are intended to be used with, but are not limited to, the OrthoLock system.
- Anchoring Pins: The Anchoring Pins are components of the Hip, Trauma and Knee Modules of the Stryker Navigation System and intended to be used to rigidly fixate a Tracker to a single bone.
Product codes
NDM
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone (for hip, knee, and other trauma applications)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 5 2010
SterilMed, Inc. % Mr. Garrett Ahlborg 11400 731d Avenue North Maple Grove, Minnesota 55369
Re: K100707
Trade/Device Name: Reprocessed Pins Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: NDM Dated: June 17, 2010 Received: June 18, 2010
Dear Mr. Ahlborg:
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
1
Page 2 - Mr. Garrett Ahlborg
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 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.
for
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the logo for Steril Med, INC. The text below the company name says "Medical Device Reprocessing" and "Small Equipment & Instrument Repair". The logo is in black and white.
Indications for Use
510(k) Number (if known): 《 | 0 0 7 0 7
Device Name: Reprocessed Pins
Indications for Use:
The pins are intended to be used to rigidly fixate a Tracker to a single bone during computer assisted surgical procedures including hip, knee, and other trauma applications. Specifically:
- Navigation and Ortholock Ex-Pins: The intended use of the Stryker OrthoLock Ex-Pins is to . rigidly fixate a Tracker to the bone undergoing treatment. The Stryker OrthoLock Ex-Pins are intended to be used with, but are not limited to, the OrthoLock system.
- Anchoring Pins: The Anchoring Pins are components of the Hip, Trauma and Knee Modules of . the Stryker Navigation System and intended to be used to rigidly fixate a Tracker to a single bone.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil R Pode for mxvm
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | K100707 | Page 1 of 1 |
|---|---|---|
| --------------- | --------- | ------------- |
CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.
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