(105 days)
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.
Reprocessed Pins
This document is a 510(k) premarket notification decision letter from the FDA regarding "Reprocessed Pins" by SterilMed, Inc. It does not contain the detailed information required to answer your questions about acceptance criteria and study particulars for a device performance study.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has a similar intended use, technological characteristics, and safety and effectiveness profile. The Indications for Use are provided, stating the pins are intended to rigidly fixate a Tracker to a single bone during computer-assisted surgical procedures.
However, the letter does not include:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone (algorithm only) performance study.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
These details would typically be found in the 510(k) submission itself, or in a more detailed summary of safety and effectiveness data, which is not provided in the snippet. The FDA's 510(k) decision letter focuses on regulatory approval based on substantial equivalence, rather than detailing the specifics of the underlying performance studies.
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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
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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
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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.
Page 5 of 23
§ 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.