(90 days)
No
The device description focuses on mechanical components (screws, washers, instruments) and their materials and dimensions. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML.
No.
The device is a bone fixation system, which aids in the healing process of bone injuries but does not directly treat or cure a disease or condition itself.
No
The device is described as an OsteoMed Cannulated Screw System, which consists of screws and washers used for bone fixation. Its intended use is for "bone fixation of hand and foot following trauma or osteotomy," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly lists physical components such as screws, washers, depth gauges, screw drivers, drills, countersinks, k-wires, and preparation instruments, all made from materials like Titanium alloy, stainless steel, anodized aluminum, and medical grade polymer. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The OsteoMed Cannulated Screw System is a system of screws, washers, and instruments used for bone fixation during surgery. It is implanted directly into the body.
- Intended Use: The intended use is for "bone fixation of hand and foot following trauma or osteotomy." This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The device is a surgical implant and associated instrumentation, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The OsteoMed Cannulated Screw System is indicated for bone fixation of hand and foot following trauma or osteotomy. Screws and washers are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The OSTEOMED Cannulated Screw System is comprised of screws and washers used for bone fixation of the hand and foot following trauma or osteotomy. The System features cannulated screws in the following dimensions:
2.0mm screw diameter - 6mm to 42mm screw length;
2.4mm screw diameter - 6mm to 52mm screw length;
3.0mm screw diameter - 10mm to 40mm screw length;
3.5mm screw diameter - 12mm to 52mm screw length;
4.0mm screw diameter - 12mm to 52mm screw length;
5.5mm screw diameter - 12mm to 52mm screw length;
6.5mm screw diameter - 20mm to 120mm screw length;
8.0mm screw diameter - 30mm to 140mm screw length;
The implants (screws and washers) of the OsteoMed Cannulated Screw System are made from Titanium alloy (ASTM F-136). Modifications to screws and washer of the subject system include redesign of the 4.0mm cannulated screw to increase the strength of the lag portion and addition of a 3.0mm diameter cannulated screw and washer.
The system instruments include depth gauges, screw drivers, drills, countersinks, k-wires, and preparation instruments to facilitate the placement of screws. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and foot
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 3.0mm and 4.0mm cannulated screws underwent verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use.
Performance equivalence was shown through the verification comparison to the predicate device and reference device.
Clinical testing is not required to support substantial equivalence.
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.
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 seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like figure with three heads, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2015
Osteomed Corp. Mrs. Piedad Peña Regulatory Affairs Specialist 3885 Arapaho Road Addison, Texas 75001
Re: K151021
Trade/Device Name: Osteomed Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: June 16, 2015 Received: June 17, 2015
Dear Mrs. Peña:
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
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
2
Indications for Use
510(k) Number (if known): K151021 (page 1/1)
Device Name: OsteoMed Cannulated Screw System
Indications for Use:
The OsteoMed Cannulated Screw System is indicated for bone fixation of hand and foot following trauma or osteotomy. Screws and washers are intended for single use only.
Prescription Use X (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)
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Image /page/3/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in large, bold letters. The word "Osteo" is in blue, and the word "Med" is in gray. The logo is surrounded by a blue and gray oval shape. The logo is simple and modern, and it is likely used to represent a medical company.
Special 510(k) Summary
| Name of Submitter: | OsteoMed
3885 Arapaho Road
Addison, Texas 75001
Phone: (972) 677-4600
Fax: (972) 677-4601 |
|--------------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Piedad Peña |
| Date Prepared: | July 8, 2015 |
| Device Proprietary Name: | OsteoMed Cannulated Screw System |
| Device Common Name: | Cannulated bone screws, washers and associated instruments |
| Classification Name: | 21 CFR 888.3040: Smooth or threaded metallic bone fixation
fastener |
| Product Code: | HWC |
Predicate Device: OsteoMed Extended 2.0/2.4 Cannulated Screw System, K062863 Classification Name: Smooth or threaded metallic fixation fastener (21CFR 888.3040, Product Code HWC) Device Class: II Reference Device: OsteoMed Super Screw System, K954330 Classification Name: Smooth or threaded metallic fixation fastener (21CFR 888.3040, Product Code HWC) Device Class: II
Summary:
Device Description:
The OSTEOMED Cannulated Screw System is comprised of screws and washers used for bone fixation of the hand and foot following trauma or osteotomy. The System features cannulated screws in the following dimensions:
2.0mm screw diameter - 6mm to 42mm screw length;
2.4mm screw diameter - 6mm to 52mm screw length;
3.0mm screw diameter - 10mm to 40mm screw length;
3.5mm screw diameter - 12mm to 52mm screw length;
4.0mm screw diameter - 12mm to 52mm screw length;
5.5mm screw diameter - 12mm to 52mm screw length;
6.5mm screw diameter - 20mm to 120mm screw length;
8.0mm screw diameter - 30mm to 140mm screw length;
Image /page/3/Picture/16 description: The image contains the Colson logo. The logo consists of the word "Colson" in a bold, sans-serif font, with a vertical line extending above the "l". To the right of the logo is the text "A COLSON A", also in a sans-serif font, but smaller and less bold than the main logo. The background of the image is plain white.
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Image /page/4/Picture/0 description: The image shows the logo for OsteoMed. The logo is in an oval shape with a blue line at the top and a gray line at the bottom. The word "OsteoMed" is written in blue and gray inside the oval.
The implants (screws and washers) of the OsteoMed Cannulated Screw System are made from Titanium alloy (ASTM F-136). Modifications to screws and washer of the subject system include redesign of the 4.0mm cannulated screw to increase the strength of the lag portion and addition of a 3.0mm diameter cannulated screw and washer.
The system instruments include depth gauges, screw drivers, drills, countersinks, k-wires, and preparation instruments to facilitate the placement of screws. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.
Indications for Use:
The OsteoMed Cannulated Screw System is indicated for bone fixation of hand and foot following trauma or osteotomy. Screws and washers are intended for single use only.
Technological Characteristics:
The OsteoMed Cannulated Screw System is available in a variety of sizes and is recommended for bone fixation in the hand and foot.
Cannulated Screw System implants (screws and washers) are manufactured from Titanium alloy (ASTM F-136), the same materials used in the manufacture of the predicate devices. This material is biocompatible.
Performance/Clinical Data:
The OsteoMed Cannulated Screw System was compared to the reference device, OsteoMed Super Screw System (K954330), and predicate device, OsteoMed Extended 2.0/2.4 Cannulated Screw System (K062863). The 3.0mm and 4.0mm cannulated screws underwent verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use. The intended use of the OsteoMed Cannulated Screw System is the same as OsteoMed Extended 2.0/2.4 Cannulated Screw System (K062863).
Performance equivalence was shown through the verification comparison to the predicate device and reference device.
Clinical testing is not required to support substantial equivalence.
Substantial Equivalence:
The basis of substantial equivalence for this device, OsteoMed Cannulated Screw System, is based on similarities in intended use, material, function, performance, design, technology, sterilization, and operational principles to the predicate device, OsteoMed Extended 2.0/2.4 Cannulated Screw System (K062863). A performance comparison was performed and verified that the cannualated screws met required mechanical strength criteria for their intended use compared to the legally marketed predicate device and reference device listed in this summary. OsteoMed believes that the non-clinical tests demonstrate that the device is as safe, and effective as the predicate device.
OsteoMed 3885 Arapaho Road Addison. Texas 75001 (973) 677-4600 FAX: (800) 390-2620 Customer Service: (800) 456-7779
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