(85 days)
Not Found
No
The 510(k) summary describes a mechanical orthopedic screw and does not mention any software, image processing, AI, or ML.
No
The device is a screw designed for fracture fixation and reconstruction of small bones, which is a surgical implant rather than a therapeutic device in the sense of delivering therapy (like drug delivery, radiation therapy, or electrical stimulation).
No
The device is described as an osteopenic screw, which is a medical implant used for fracture fixation, osteotomies, and reconstruction/arthrodeses. Its purpose is treatment, not diagnosis. The provided text details its physical characteristics, material, and performance testing related to strength, but does not mention any diagnostic capabilities or functions.
No
The device description clearly states it is a physical screw manufactured from titanium alloy, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the Salvation™ Osteopenic Screw is for the treatment of fracture fixation, osteotomies, and reconstruction/arthrodeses of small bones. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a physical implant (a screw) made of titanium alloy. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
In summary, the Salvation™ Osteopenic Screw is a surgical implant used for structural support and fixation within the body, which is a completely different category of medical device than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Salvation™ Osteopenic Screw is indicated for the treatment of fracture fixation, osteotomies, and reconstruction/arthrodeses of small bones, as well as patients with osteopenic bone.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The SALVATION™ Osteopenic Screws are non-locking, fully threaded screws offered in various diameters and lengths. All described implants are manufactured from titanium alloy and have a solid core. The implants are single use only devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones
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)
Torsion testing and testing rationales related to bending and pull-out strength were provided to support the substantial equivalence of the subject device and show that no new worst-case devices are introduced in this system.
The safety and effectiveness of the SALVATION™ Osteopenic Screw is adequately supported by the mechanical testing, testing rationales, substantial equivalence information, materials information and comparison of design characteristics provided within this premarket notification. Through the analysis of technical characteristics the new devices are substantially equivalent to the predicate devices.
The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image contains the word "WRIGHT" in large, bold, black letters. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in smaller, thinner, black letters. To the left of the word "WRIGHT" is a black geometric shape.
K140408 page 1 of
1023 Cherry Road!
901 867 9971
vmt.com
510(K) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the WMT SALVATION™ Osteopenic Screw.
(a)(1). Submitted By:
Date:
Contact Person:
(a)(2). Proprietary Name: Common Name: Classification Name and Reference: Device Product Code, Device Panel:
(a)(3). Predicate Devices:
Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117
May 1, 2014
Val Mýles Regulatory Affairs Specialist Office - (901) 290-5162 Fax – (901) 867-4190
SALVATION™ Osteópenic Screw Bone Screw 21 CFR 888.3040 - Class II HWC: Screw, Fixation, Bone ·
K110670: VLP FOOT Talus and Percutaneous Calcaneus Bone Plates, VLP Bone Screws; PERI-LOC Ankle Fusion Bone Plates and Instruments
K090675: VLP FOOT Plating, Screw System, and Accessories
(a)(4). Device Description
The SALVATION™ Osteopenic Screws are non-locking, fully threaded screws offered in various diameters and lengths. All described implants are manufactured from titanium alloy and have a solid core. The implants are single use only devices.
(a)(5). Intended Use
The Salvation™ Osteopenic Screw is indicated for the treatment of fracture fixation, osteotomies, and reconstruction/arthrodeses of small bones, as well as patients with osteopenic bone.
1
(a)(6). Technological Characteristics Comparison
The Salvation™ Osteopenic Screw is technologically substantially equivalent to the predicate device.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Torsion testing and testing rationales related to bending and pull-out strength were provided to support the substantial equivalence of the subject device and show that no new worst-case devices are introduced in this system.
The safety and effectiveness of the SALVATION™ Osteopenic Screw is adequately supported by the mechanical testing, testing rationales, substantial equivalence information, materials information and comparison of design characteristics provided within this premarket notification. Through the analysis of technical characteristics the new devices are substantially equivalent to the predicate devices.
(b)(2). Substantial Equivalence – Clinical Evidence
N/A
(b){3). Substantial Equivalence - Conclusions
The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with three curved lines representing its body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 14, 2014
Wright Medical Technology, Incorporated Ms. Val Myles Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K140408
Trade/Device Name: SALVATION™ Osteopenic Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 2, 2014 Received: May 5, 2014
Dear Ms. Myles:
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 -- Ms. Val Myles
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" (2) CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K140408
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510{k} Number (if known)
Device Name SALVATION™ Osteopenic Screw
Indications for Use (Describe)
The Salvation™ Osteopenic Screw is indicated for the treatment of fractornies, and reconstruction/arthrodeses of small bones, as well as patients with osteopenic bone.
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)
. .
PRC Publishing Bervices (201) 463-6740
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY :
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Elizabeth L. Frank -S
Division of Orthopedic Devices
FORM FDA 3881 (1/14)
E3 - 1
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