(49 days)
No
The summary describes a mechanical external fixation device and its reprocessing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is indicated for the treatment of fractures and correction of deformities, which are therapeutic applications.
No
Explanation: The device is an external fixation device used for treating fractures and correcting deformities, not for diagnosing medical conditions. Its intended use is therapeutic/reconstructive rather than diagnostic.
No
The device description explicitly lists hardware components such as frames, clamps, rods, pins, and screws, and mentions materials like metal alloys, plastic, and composites. The performance studies focus on the effects of reprocessing on these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the physical treatment of fractures and other orthopedic conditions through external fixation. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details components like frames, clamps, pins, and screws made of metal, plastic, and composites. These are all physical components used for mechanical support and manipulation of bone.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on functionality testing and post-reprocessing inspection, confirming the device's ability to perform its intended mechanical function. There are no studies related to diagnostic accuracy or analytical performance.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Reprocessed Stryker External Fixation Devices intended to be used for the fixation of supracondylar, or condylar fractures of the femur; for fusion of a joint; for surgical procedures that involve cutting the bone, for fixation of bone fractures; bone reconstruction; as a guide pin for insertion of other implants; or may be implanted through the skin so that a pulling force or traction may be applied to the skeletal system; and others 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.
Reprocessed Stryker External Fixation Devices are indicated for use in patients requiring external fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
Product codes
KTT, JEC, KTW
Device Description
External fixation devices are specially designed frames, clamps, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Verification analyses consisting of device functionality testing and post-reprocessing inspection of components were performed to evaluate the effects of the reprocessing procedures on the subject device. Performance testing demonstrates that the Reprocessed Stryker External Fixation Devices perform as originally intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other, representing the human element of the department's work.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2016
Stryker Sustainability Solutions Ms. Kelli Drver Senior Regulatory Affairs Specialist 1810 West Drake Drive Tempe, Arizona 85283
Re: K153415 Trade/Device Name: Reprocessed Stryker External Fixation Devices Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, JEC, KTW Dated: December 9, 2015 Received: December 14, 2015
Dear Ms. Dryer:
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 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153415
Device Name
Reprocessed Stryker External Fixation Device
Indications for Use (Describe)
Reprocessed Stryker External Fixation Devices are indicated for use in patients requiring external fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ✘ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ❏ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 4: 510(k) Summary
SUBMITTER:
Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, Arizona 85283
CONTACT:
Kelli Dryer Senior Regulatory Affairs Specialist 480-763-5324 (direct) 480-763-5310 (fax)
November 24, 2015 Date of Preparation:
NAME OF DEVICE:
| Trade/Proprietary Name: | Reprocessed Stryker External Fixation Devices |
|---|---|
| Common Name: | External Fixation Devices, Fixation Appliance, Single/Multiple |
| Component | |
| Classification Name: | Single/Multiple Component Metallic Bone Fixation Appliances and |
| Accessories and Smooth or Threaded Metallic Bone Fixation Fastener |
DEVICE CLASS
| Class: | II |
|---|---|
| Review Panel: | Orthopedic |
| Product Code: | KTT, JEC, KTW |
| Regulation Number Citation: | 888.3030, 888.3040, 888.3030 |
Table 1. Device Class Information
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PREDICATE DEVICES:
| 510(k) Number | 510(k) Title | Original Manufacturer |
|---|---|---|
| K052062 - | ||
| Primary | Modification to Reprocessed Howmedica | |
| External Fixation Devices [Non-Sterile] | Alliance Medical Corporation | |
| K012648 - | ||
| Secondary | Reprocessed Howmedica External Fixation | |
| Devices [Sterile] | Alliance Medical Corporation |
Table 2. Predicate Devices
DEVICE DESCRIPTION:
External fixation devices are specially designed frames, clamps, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.
INTENDED USE:
The Reprocessed Stryker External Fixation Devices intended to be used for the fixation of supracondylar, or condylar fractures of the femur; for fusion of a joint; for surgical procedures that involve cutting the bone, for fixation of bone fractures; bone reconstruction; as a guide pin for insertion of other implants; or may be implanted through the skin so that a pulling force or traction may be applied to the skeletal system; and others 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.
INDICATIONS STATEMENT:
Reprocessed Stryker External Fixation Devices are indicated for use in patients requiring external fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
The design, materials, and intended use of the Reprocessed Stryker External Fixation Devices are the same as the predicate devices. The mechanism of the Reprocessed Stryker External Fixation Device is identical to the predicate devices in the same standard mechanical design, materials, shapes and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specification, or method of operation. The line extension is to add new model numbers to the predicate device line. Although the predicate devices will continue to be marketed, the Reprocessed Stryker External Fixation Devices will offer additional components and include minor design and material modifications.
PERFORMANCE TESTING:
Verification analyses consisting of device functionality testing and post-reprocessing inspection of components were performed to evaluate the effects of the reprocessing procedures on the subject device. Performance testing demonstrates that the Reprocessed Stryker External Fixation Devices perform as originally intended.
CONCLUSION:
The information summarized in the Design Control Activities Summary demonstrates that the Reprocessed Stryker External Fixator Device met the pre-determined acceptance criteria for the verification activities identified.
There is no change to the fundamental scientific technology, indicated use or material types or the proposed line extension devices.
Stryker Sustainability Solutions concludes that the line extension device (the Reprocessed Stryker External Fixation Device) is safe, effective and substantially equivalent to the predicate devices, as described herein.