(121 days)
The Osteomed Headless Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.
The OsteoMed Headless Cannulated Screw system is comprised of screws in diameters of 2.0mm (10-42mm length), 2.4mm (10-50mm length), 3.0mm (10-40mm length), 4.0mm (12-52mm length) and 6.5mm (40-120mm length). The screws are made of Titanium Alloy (ASTM F-136). Guide Wires, drills, taps, drivers, handle, depth gauge, bone clamp, screw extractor and preparation instruments will also be a part of the system.
This 510(k) summary describes a medical device, specifically the OsteoMed Headless Cannulated Screw System, which is a type of bone screw used for orthopedic fixation. For such devices, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally evaluated based on substantial equivalence to predicate devices rather than a direct statistical performance study against defined metrics like those for diagnostic AI systems.
Therefore, many of the requested fields (like sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable in the context of this 510(k) submission for a mechanical implantable device.
Here's how the information provided aligns with your request, focusing on the available details:
Acceptance Criteria and Device Performance for OsteoMed Headless Cannulated Screw System
For implantable medical devices like bone screws, the primary acceptance criteria for 510(k) clearance is demonstrating substantial equivalence to already legally marketed (predicate) devices. This typically involves demonstrating similar:
- Intended Use: The purpose for which the device is used.
- Technological Characteristics: Materials, design, operational principles.
- Safety and Effectiveness: Assessed through comparison of the above characteristics, and often supported by material testing, mechanical testing, and sometimes bench or animal studies (though not explicitly detailed in summaries like this unless significant differences exist).
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (based on substantial equivalence) | Reported Device Performance (as demonstrated by comparison) |
|---|---|
| Intended Use: Bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws intended for single use only. | The intended use matches that of the identified predicate devices (Nexa Compression Pin, Wright Multi Use Compression Screw, Zimmer Herbert Bone Screw, Vilex/Duval/Orthex Cannulated Bone Screw, OsteoMed Super Screw System). |
| Technological Characteristics - Material: Titanium Alloy (ASTM F-136) | The device is made of Titanium Alloy (ASTM F-136), which is a commonly used and accepted material for bone screws, similar to what is likely used in predicate devices. |
| Technological Characteristics - Design: Headless, cannulated screws in various diameters (2.0mm, 2.4mm, 3.0mm, 4.0mm, 6.5mm) and lengths, with associated instruments. | The design (headless, cannulated, specified dimensions, and system components) is described as having "similarities in intended use, material, design and operational principle" to the listed predicates. No new safety or effectiveness issues are identified. |
| Safety and Effectiveness: No new safety or effectiveness issues raised compared to predicate devices. | The submission asserts that "Due to the similarity of materials and design to both pre-enactment and post-enactment devices, OsteoMed believes that the OsteoMed Headless Cannulated Screw System does not raise any new safety or effectiveness issues." This is the core 'proof' of meeting this criterion in a 510(k). |
Additional Information (N/A for this type of device, or based on submission content):
- Sample size used for the test set and the data provenance: Not applicable. This is not a diagnostic AI device requiring a clinical test set with patient data. Performance is primarily based on engineering and material comparisons.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for this type of device is established through engineering specifications, material standards (e.g., ASTM F-136), and regulatory requirements for mechanical devices, not expert image interpretation.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a mechanical implant, not a diagnostic AI system.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a mechanical implant, not an algorithm.
- The type of ground truth used: For mechanical devices, "ground truth" is generally defined by engineering specifications, material properties, and performance standards (e.g., mechanical strength, corrosion resistance, biocompatibility). These are evaluated through bench testing and adherence to recognized standards, which are not detailed in this 510(k) summary but are part of the full submission. The primary ground truth for substantial equivalence is the performance and safety track record of the predicate devices.
- The sample size for the training set: Not applicable. There is no AI model being trained.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study Proving Acceptance Criteria (Substantial Equivalence):
The "study" proving the device meets the acceptance criteria is detailed in the 510(k) submission itself. It's a comparative analysis demonstrating substantial equivalence rather than a clinical trial or performance study against specific metrics.
- Methodology: The submission identifies five predicate devices:
- Principle of Equivalence: The submitter states: "Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Nexa Compression Pin cleared under K060071, the Wright Multi Use Compression Screw (K043102), the Zimmer Herbert Bone Screw (K792022), the Vilex/Duval/Orthex Cannulated Bone Screw (K014154) and the OsteoMed Super Screw System (K954330)."
- Conclusion: The submission concludes that "Due to the similarity of materials and design to both pre-enactment and post-enactment devices, OsteoMed believes that the OsteoMed Headless Cannulated Screw System does not raise any new safety or effectiveness issues." The FDA's clearance letter (K063298) confirms this finding of substantial equivalence.
In essence, for this type of device and submission, the "study" is the comprehensive documentation and comparison provided to the FDA, which convinces the agency that the new device is as safe and effective as existing, legally marketed predicate devices.
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510(k) Summary
MAR 0 2 2007
Device Proprietary Name:
Device Common Name:
Classification Name:
Name of Submitter:
OsteoMed Headless Cannulated Screw System
Bone Screw
HWC, Screw, Fixation, Bone
OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-4601
Contact Person:
Date Prepared:
Dawn D. Tindall October 31 . 2006
Summary:
This submission describes the OsteoMed Headless Cannulated Screw System indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.
The OsteoMed Headless Cannulated Screw system is comprised of screws in diameters of 2.0mm (10-42mm length), 2.4mm (10-50mm length), 3.0mm (10-40mm length), 4.0mm (12-52mm length) and 6.5mm (40-120mm length). The screws are made of Titanium Alloy (ASTM F-136). Guide Wires, drills, taps, drivers, handle, depth gauge, bone clamp, screw extractor and preparation instruments will also be a part of the system.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Nexa Compression Pin cleared under K060071, the Wright Multi Use Compression Screw (K043102), the Zimmer Herbert Bone Screw (K792022), the Vilex/Duval/Orthex Cannulated Bone Screw (K014154) and the OsteoMed Super Screw System (K954330).
Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed Headless Cannulated Screw System does not raise any new safety or effectiveness issues.
OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (972) 677-4601 Customer Service: (800) 456-7779
Image /page/0/Picture/21 description: The image shows a logo with the word "Colson" in a stylized font. The logo also includes the text "A COLSON ASSO", which is likely part of a company or organization name. The logo appears to be for a company named Colson or an organization associated with Colson.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus symbol with three wavy lines representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OsteoMed L.P. % Ms. Dawn D. Tindall 3885 Arapaho Road Addison, Texas 75001
MAR 0 2 2007
K063298 Re: Trade/Device Name: OsteoMed Headless Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: II Product Code: HWC Dated: February 5, 2007 Received: February 6, 2007
Dear Ms. Tindall:
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 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.
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Page 2 - Ms. Dawn D. Tindall
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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Mikkelsen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K063298 / S00 1
Device Name: __ OsteoMed Headless Cannulated Screw System Indications for Use:
The Osteomed Headless Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.
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)
(Posted November 13, 2003)
Mark A. Millken
Page of
(Division Sign-Off) Division of Ceneral, Restorative, and Neurole Jeal Devices
510(k) Number.
§ 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.