(108 days)
Not Found
No
The summary describes a mechanical bone screw and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is used for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, all of which are therapeutic medical interventions.
No
The provided text describes PMT Bone Screws as devices used for bone reconstruction, repair, and fixation, not for diagnosing conditions. Their function is therapeutic/reconstructive.
No
The device description clearly states it is a physical bone screw made of Titanium Alloy, available in various sizes and configurations. It is a hardware device, not software.
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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of the PMT Bone Screws clearly indicate they are implanted medical devices used for surgical procedures involving bone. They are physically placed within the body to provide structural support and fixation.
The information provided about the device's material, design features, and intended surgical applications confirms it is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The PMT Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only.
Product codes
HWC
Device Description
The design features of the PMT Bone Screws are described below.
- Manufactured from Titanium Alloy .
- Available headed or headless ●
- Available in various diameters and lengths .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
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)
Wright Compression Screws (K082320), ORTHOLOC Bone Screws (K112772)
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
Providence Medical Technology, Inc.
Section 5. 510(k) Summary
PMT Bone Screws K121713 ( 1/2)
SEP 27 2012
| 510(k) Owner: | Providence Medical Technology, Inc. |
|---|---|
| 201 Spear Street, Suite 1310 | |
| San Francisco, CA. 94105 | |
| T: 415-923-9376 | |
| F: 415-923-9377 | |
| Contact Person: | Glen Mangseth |
| gmangseth@providencemt.com | |
| T: 415-923-9376 | |
| Date Summary Prepared: | June 10, 2012 |
| Trade Name: | PMT Bone Screws |
| Common Name: | Bone Screw |
| Device Classification Regulation: | 21 CFR 888.3040 - Class II |
| Device Product Code & Panel: | HWC: Screw, Fixation Bone |
| 87, Orthopedics | |
| Predicate Device: | Wright Compression Screws (K082320) |
| ORTHOLOC Bone Screws (K112772) |
Device Information
A. Intended Use
The PMT Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only.
B. Device Description
The design features of the PMT Bone Screws are described below.
- Manufactured from Titanium Alloy .
- Available headed or headless ●
- Available in various diameters and lengths .
1
PMT Bone Screws
K 121713 (2/2)
C. Substantial Equivalence Information
י
:
The design features, material, and indications for use of the PMT Bone Screws are substantially equivalent to previously cleared predicate devices. The safety and effectiveness of the PMT Bone Screws is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 27 2012
Providence Medical Technology, Incorporation % Mr. Glen Mangseth Quality Systems Manager 201 Spear Street, Suite 1310 San Francisco, California 94105
Re: K121713
Trade/Device Name: PMT Bone Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 20, 2012 Received: August 20, 2012
Dear Mr. Mangseth:
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 - Mr. Glen Mangseth
CFR Part 807); labeling (21 CFR Part 801); medical device 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,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4. Indications for Use Statement
Indications for Use Form (Text Version)
Indications for Use
510(k) Number (if known):
· Device Name: PMT Bone Screws
Indications for Use:
PMT Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Prescription Use (Part 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ashb
Page 1 of 1
(Division Sign-Cil) Division of Surgual. Orthopedic, and Restorative Devices
×1273 510(k) Number .