(91 days)
No
The 510(k) summary describes a mechanical device (screws) and does not mention any software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device is a headless compression screw system intended for fixation of fractures and non-unions of small bones, which is a structural or mechanical function rather than a therapeutic one (i.e., treating or preventing disease).
No
This device is a surgical implant (screw fasteners) used for fixation of fractures and non-unions of bones. It is a treatment device, not a diagnostic one.
No
The device description clearly states it consists of cannulated screws, drills, and guide wires, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of fractures and non-unions of small bones and small bone arthrodesis." This is a surgical procedure involving the physical repair of bones.
- Device Description: The device is described as "cannulated screws" made of titanium, used as "screw fasteners." This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The Headless Compression Screw System Micro-2.8 screw fasteners are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.
The Headless Compression Screw System Mini-3.9 screw fasteners are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodeses of the carpals and phalanges, steochondritis dissecans, and ligament fixation.
The screw fasteners are intended for single use only and may not be reused under any circumstances.
The system drills and guide wires are single use instruments.
Product codes
HWC
Device Description
The OsteoCentric Extremities Headless Compression Screw System within the product line of SMV Scientific Cannulated Screws consists of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws are provided nonsterile. The subject headless compression screws are manufactured from Titanium per ASTM F136. The Headless Compression Screw System fasteners are offered in diameters of Ø2.8mm or Ø3.9mm and lengths from 12mm to 50mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones and small bone fragments, including scaphoid and other carpal bones, metacarpals, phalanges, metatarsals.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
OsteoCentric Extremities has conducted engineering analyses and geometric comparisons to demonstrate that the modifications to the subject Headless Compression Screw System introduce no new worstcase for mechanical testing compared to what was tested under K170021.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 4, 2020
OsteoCentric Extremities, LLC % Meredith May Director of Consulting Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K200259
Trade/Device Name: Headless Compression 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: January 31, 2020 Received: February 3, 2020
Dear Meredith May:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
DEPARTMENT OF HEALTH AND HUMANSERVICES
Food and Drug Administration
Indications for Use
510(k) Number (if known) K200259
Device Name
OsteoCentric Extremities Headless Compression Screw System
Indications for Use (Describe)
The Headless Compression Screw System Micro-2.8 screw fasteners are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.
The Headless Compression Screw System Mini-3.9 screw fasteners are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodeses of the carpals and phalanges, steochondritis dissecans, and ligament fixation.
The screw fasteners are intended for single use only and may not be reused under any circumstances.
The system drills and guide wires are single use instruments.
| 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) |
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| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------- |
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020
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510(K) SUMMARY
| Submitter's Name: | OsteoCentric Extremities, LLC |
|---|---|
| Submitter's Address: | 5113 Southwest Parkway, Suite 150 |
| Austin, TX 78735 | |
| Submitter's Telephone: | 1-800-969-0639 |
| Contact Person: | Meredith May, MS RAC |
| Empirical Testing Corp. | |
| 719-337-7579 | |
| mmay@empiricaltech.com | |
| Date Summary was Prepared: | 31-Jan-2020 |
| Trade or Proprietary Name: | Headless Compression Screw System |
| Common or Usual Name: | Smooth or Threaded Metallic Bone Fixation Fastener |
| Classification: | Class II per 21 CFR §888.3040 |
| Product Code: | HWC |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The OsteoCentric Extremities Headless Compression Screw System within the product line of SMV Scientific Cannulated Screws consists of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws are provided nonsterile. The subject headless compression screws are manufactured from Titanium per ASTM F136. The Headless Compression Screw System fasteners are offered in diameters of Ø2.8mm or Ø3.9mm and lengths from 12mm to 50mm.
INDICATIONS FOR USE
The Headless Compression Screw System Micro-2.8 screw fasteners are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.
The Headless Compression Screw System Mini-3.9 screw fasteners are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodeses of the carpals and phalanges, steochondritis dissecans, and ligament fixation.
The screw fasteners are intended for single use only and may not be reused under any circumstances.
The system drills and guide wires are single use instruments.
The indications for use for the subject Headless Compression Screw System are that of the previously cleared Cannulated Screws (K170021).
4
TECHNICAL CHARACTERISTICS
The OsteoCentric Extremities Headless Compression Screw System are made from titanium per ASTM F136. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- Indications for Use ●
- Materials of manufacture .
- Principles of operation ●
- . Sizes
Table 5-1 Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K170021 | SMV Scientific Cannulated Screws | SMV Scientific | Primary |
| K081011 | AREX SCRU2 Headless Compression Screws | AREX USA | Additional |
| K152000 | SMV Bone Plate and Screw System | SMV Scientific | Reference |
PERFORMANCE TESTING SUMMARY
In support of this Special 510(k) Device Modification Premarket Notification, OsteoCentric Extremities has conducted engineering analyses and geometric comparisons to demonstrate that the modifications to the subject Headless Compression Screw System introduce no new worstcase for mechanical testing compared to what was tested under K170021.
CONCLUSION
The subject OsteoCentric Extremities Headless Compression Screw System is very similar to previously cleared Cannulated Screws (K170021). The subject Headless Compression Screw System fasteners have similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The modifications raise no new types of safety or effectiveness questions. The overall technology characteristics and mechanical performance evaluation lead to the conclusion that the OsteoCentric Extremities Headless Compression Screw System is substantially equivalent to the predicate devices.