(57 days)
Not Found
No
The 510(k) summary describes a mechanical external fixation system and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
It is intended to stabilize and provide treatment for fractures which is a therapeutic purpose.
No
The device is an external fixation system used to stabilize and treat fractures. Its primary function is therapeutic (stabilization) rather than diagnostic (identifying or characterizing a medical condition).
No
The device is described as an "External Fixation System" intended to stabilize fractures. This strongly implies a physical hardware device, not software. The lack of any mention of software in the description further supports this conclusion.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This includes tests for diagnosis, monitoring, screening, and prognosis.
- Device Description and Intended Use: The description and intended use of the Stryker® External Fixation System clearly state that it is a device used to stabilize and treat fractures directly on the patient's body. It is a surgical implant/device used for mechanical support and fixation of bones.
- No Mention of Specimens or Testing: There is no mention of analyzing biological specimens or performing any kind of diagnostic test on samples taken from the body.
Therefore, based on the provided information, the Stryker® External Fixation System is a surgical device used for external fixation, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Stryker® External Fixation System is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
Product codes
MQN, KTT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillofacial area, mandibular
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)
K053038, K961916, K971755, K973321, K040258, K062299
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: Stryker® Twist Drills
General Information
| Proprietary Name: | Stryker® External Fixation System |
|---|---|
| Common Name: | External Fixation System |
| Proposed Regulatory Class: | Class II |
| Device Classification: | MQN (21 CFR 872.4760) External Mandibular Fixator and/or |
| Distractor | |
| KTT (21 CFR 888.3030) Single/multiple component metallic bone | |
| fixation appliances and accessories. | |
| Submitter: | Stryker® Craniomaxillofacial |
| 750 Trade Centre Way | |
| Suite 200 | |
| Kalamazoo, MI 49002 | |
| 877-534-2464 x 4250 | |
| Submitter's Registration #: | 3005101424 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Tennille Folk |
| Regulatory Affairs Representative | |
| Phone: 877-534-2464 x 4250 | |
| Fax: | |
| 269-323-4215 | |
| Summary Preparation Date: | June 11, 2007 |
Intended Use
The Stryker® External Fixation System is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, turnor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
Substantial Equivalency Information
Stryker® considers the Stryker® External Fixation System are substantially equivalent to the already cleared Hoffman II Compact MRI External Fixation System (K053038), Hoffman II Compact External Fixation System (K961916, K971755 & K973321), Synthes Medium External Fixation System-MR Safe (K040258) and Synthes Sterile Mandible External Fixator (K062299).
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker® Craniomaxillofacial % Ms. Tennillee Folk Senior Regulatory Affairs Representative 750 Trade Centre Way Suite 200 Kalamazoo, MI 49002
AUG 1 0 2007
Re: K071628
Trade/Device Name: Stryker® External Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: External Mandibular Fixator and/or Distractor Regulatory Class: II Product Code: MQN, KTT Dated: June 11, 2007 Received: June 14, 2007
Dear Ms. Folk:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 801); good manufacturing practice requirements.os 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.
2
Page 2 -- Ms. Tennillee Folk
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
ncerely vours.
Barbara Borchert
Mark N. Melke Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(K) Number (if known): K
Device Name: Stryker® External Fixation System
Indications for Use:
The Stryker® External Fixation System is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
Prescription Use (21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aarbara Buchen
(Division Sign Off) by Page _ of _
(Posted November 13, 2003)
Division of General, Restorative,
and Neurological Devices
510(k) Number K071628