(45 days)
Not Found
No
The summary describes a mechanical screw for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
Explanation: A therapeutic device is designed to treat a disease or condition. This device is a screw used for bone fixation and reconstruction, which is a restorative rather than a therapeutic function in this context. While it aids in recovery, its primary function is mechanical support, not direct treatment of a disease.
No
The device is described as "Snap-Off Self-Compressive Screws" for the "fixation of bone reconstruction" and "bone fractures" in forefoot surgery. Its purpose is to provide physical support and fixation, not to diagnose medical conditions or identify diseases.
No
The device description explicitly states it consists of screws made of titanium alloy, which are hardware components.
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 for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Snap-Off Self-Compressive Screws are intended for the fixation of bone reconstruction and fractures in forefoot surgery. This is a surgical implant used directly on the body, not for testing samples taken from the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Reagents, calibrators, or controls.
This device is a surgical implant, falling under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Snap-Off Self-Compressive Screws are intended for the fixation of bone reconstruction in forefoot surgery.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Snap-Off Self-Compressive Screw consists of screws available in several lengths.
All the implants are made of titanium alloy.
The fixation is provided thanks to the threading of the screw, which allows compression.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forefoot
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)
The following mechanical tests were performed:
- Resistance to torsion according to ASTM F543 Annex 1 o
- Pull out strength according to ASTM F543 Annex 3 o
The results of these testing indicate that the current Snap-Off Self-Compressive Screw is equivalent to predicate devices.
No clinical studies were performed.
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three heads in profile, facing to the right. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Neosteo % Mr. J.D. Webb The Orthomedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K150772
Trade/Device Name: Snap-off Self-compressive Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: March 13, 2015 Received: April 1, 2015
Dear Mr. J. D. Webb:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
May 8, 2015
1
the quality systems (OS) 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" (21 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/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name
Snap-Off Self-Compressive Screws
Indications for Use (Describe)
The Snap-Off Self-Compressive Screws are intended for the fixation of bone reconstruction in forefoot surgery.
Type of Use (Select one or both, as applicable)
X | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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)
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Image /page/3/Picture/0 description: The image shows the logo for Neosteo. The logo consists of an orange spiral design on the left and the word "neosteo" in orange on the right. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY" in a smaller font size.
l. SUBMITTER'S INFORMATION
A. 510(k) Owner
NEOSTEO Mallève 2A 1 Boulevard Jean Moulin 44 100 Nantes, France Tel: +33 (0)2 36 56 96 70 Fax: +33 (0)2 51 70 61 34
B. Contact Person
JD Webb The Orthomedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Tel: 512 388 0199 Fax: 512 692 3699 Email: jdwebb@orthomedix.net
C. Date of Preparation of the 510(k) Summary
19th March 2015
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Image /page/4/Picture/0 description: The image shows the logo for Neosteo. The logo consists of an orange spiral design on the left, with the word "neosteo" in orange to the right of the spiral. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY" in a smaller font, also in orange. The spiral design appears to be made up of a series of dots connected by lines.
DEVICE IDENTIFICATION II.
| "Screw" type devices | |
|---|---|
| Trade or proprietary name | Snap-Off Self-Compressive Screw |
| Common or usual name | Self-compressive screw |
| Classification regulation | 21 CFR 888.3040 |
| Proposed Regulatory Class | Class II |
| Panel | 87 "Orthopedic" |
| Product code | HWC |
| Primary Predicate Device | Spin® Snap-Off Screw (K991477) from NewDeal SA |
| Secondary Predicate Device | Self-Compressive Screws (K131471) from Neosteo |
III. DEVICE DESCRIPTION
The Snap-Off Self-Compressive Screw consists of screws available in several lengths.
All the implants are made of titanium alloy.
The fixation is provided thanks to the threading of the screw, which allows compression.
A. Materials
Snap-Off Self-Compressive Screw: Titanium alloy per ASTM F136
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Image /page/5/Picture/0 description: The image shows the logo for Neosteo. The logo consists of an orange spiral design on the left and the word "neosteo" in orange on the right. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY" in a smaller font.
510(k) Summary
IV. INTENDED USE
The Snap-Off Self-Compressive Screws are intended for the fixation of bone fractures and for bone reconstruction in forefoot surgery.
SUMMARY OF OF TECHNOLOGICAL CHARACTERISTICS / SUBSTANTIAL V. EQUIVALENCE
The Snap-Off Self-Compressive Screw is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.
VI. NON-CLINICAL TEST SUMMARY
Snap-Off Self-Compressive Screw:
The following mechanical tests were performed:
- Resistance to torsion according to ASTM F543 Annex 1 o
- Pull out strength according to ASTM F543 Annex 3 o
The results of these testing indicate that the current Snap-Off Self-Compressive Screw is equivalent to predicate devices.
VII. CLINICAL TEST SUMMARY
No clinical studies were performed.
VIII. CONCLUSIONS NON-CLINICAL AND CLINICAL
NEOSTEO considers the current Snap-Off Self-Compressive Screw to be equivalent to the predicate devices listed above. This conclusion is based on the devices' similarities in principles of operation, technology, materials and indications for use.