(14 days)
Not Found
No
The device description and intended use are purely mechanical, describing screws, washers, and instruments for fracture fixation. There is no mention of software, algorithms, or any capabilities that would suggest AI/ML.
Yes
The device is described as a "Cannulated Screw System" for "bone fracture fixation" and related surgical applications, which directly indicates its use in treating and ameliorating medical conditions.
No
The device is a system of cannulated screws and associated instruments used for fracture fixation and other orthopedic procedures, which are therapeutic rather than diagnostic.
No
The device description explicitly states that the system consists of physical components such as cannulated screws, washers, guide wires, and instruments, which are hardware.
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, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the CSS Cannulated Screw System clearly state that it is a surgical implant used for fixing bone fractures and performing osteotomies and arthrodesis. It is a physical device implanted into the body to provide structural support and stability to bones.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is entirely mechanical and structural within the body.
Therefore, based on the provided information, the CSS Cannulated Screw System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CSS Cannulated Screw System will be indicated for use in long and small bone fracture fixation, which includes the following:
- Fractures of the tarsals and metatarsals
- Fractures of the olecranon, distal humerous
- Fractures of the radius and ulna
- Patella fractures
- Distal tibia and pilon fractures
- Fractures of the fibula, medial malleolus, os calcis
- Tarso-metatarsal and metatarsal phalangeal arthrodesis
- Metatarsal and phalangeal osteotomies
- Osteochondritis dissecans
- Ligament fixation
- Other small fragment, cancellous bone fractures and osteotomies
Product codes
HWC, HTN
Device Description
The CSS Cannulated Screw System consists of cannulated screws of various diameters, lengths and thread configurations. The system also includes correspondingly sized washers, the use of which are optional, as well as guide wire and various instruments.
The cannulated screws are self tapping. They are made from made from Titanium Ti-6Al-4V ELI Alloy in conformance with ASTM F-136 Standard Specification for Wrought Titanium 6Al-4V ELI Alloy for Surgical Implant Applications.
The CSS System includes (4) different types of washers. These are; Flat Washers, Contoured Washers, Partial Contoured Washers, and Domed Washers. The various styles are intended to offer the surgeon a variety of anatomical fit to the bone in certain applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long and small bone fractures, which includes: tarsals, metatarsals, olecranon, distal humerous, radius, ulna, patella, distal tibia, pilon, fibula, medial malleolus, os calcis.
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
A Finite Element Analysis (FEA) was performed on the CSS Cannulated Screw System, in comparison to its' predicate, the Asnis III. Performance testing was also conducted to confirm the results of the FEA. Results clearly demonstrate that the CSS System is substantially to its' predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
510(k) Premarket Notification
CSS Cannulated Screw System
510(k) SUMMARY
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
OrthoHelix Surgical Designs, Inc. 1815 W. Market Suite 205 Akron, Ohio 44313 Phone: (330) 869-9563 Fax: (330) 869-9583
Contact Person: Lee A. Strnad Senior Development Manager OrthoHelix Surgical Designs, Inc.
Date Prepared: February 13, 2006
Name of Device
CSS Cannulated Screw System
Common or Usual Name
Cannulated Screws
Classification Name
Screw, Fixation, Bone
Single/Multiple Component Metallic Fixation Appliances and Accessories
Predicate Devices
Howmedica Asnis III Cannulated Screw System (K000080)
Intended Use
The CSS Cannulated Screw System will be indicated for use in long and small bone fracture fixation, which includes the following;
- · Fractures of the tarsals and metatarsals
1
510(k) Premarket Notification
CSS Cannulated Screw System
- · Fractures of the olecranon, distal humerous
- · Fractures of the radius and ulna
- · Patella fractures
- · Distal tibia and pilon fractures
- · Fractures of the fibula, medial malleolus, os calcis
- · Tarso-metatarsal and metatarsal phalangeal arthrodesis
- · Metatarsal and phalangeal osteotomies
- · Osteochondritis dissecans
- · Ligament fixation
- · Other small fragment, cancellous bone fractures and osteotomies
Device Description
The CSS Cannulated Screw System consists of cannulated screws of various diameters, lengths and thread configurations. The system also includes correspondingly sized washers, the use of which are optional, as well as guide wire and various instruments.
The cannulated screws are self tapping. They are made from made from Titanium Ti-6Al-4V ELI Alloy in conformance with ASTM F-136 Standard Specification for Wrought Titanium 6Al-4V ELI Alloy for Surgical Implant Applications.
The CSS System includes (4) different types of washers. These are; Flat Washers, Contoured Washers, Partial Contoured Washers, and Domed Washers. The various styles are intended to offer the surgeon a variety of anatomical fit to the bone in certain applications.
Performance Data
A Finite Element Analysis (FEA) was performed on the CSS Cannulated Screw System, in comparison to its' predicate, the Asnis III. Performance testing was also conducted to confirm the results of the FEA. Results clearly demonstrate that the CSS System is substantially to its' predicate.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and head. The text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 MAR 7
OrthoHelix Surgical Designs, Inc. C/o Mr. Lee A. Strnad Senior Development Manager 1815 West Market Street, Suite 205 Akron, Ohio 44313
Re: K060428
Trade/Device Name: CSS Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: HWC, HTN Dated: February 13, 2006 Received: February 21, 2006
Dear Mr. Strnad:
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
3
Page 2 - Mr. Lee A. Strnad
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Qmee
Mark N. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): TBD
Device Name: CCS Cannulated Screw System
Indications for Use: The CSS Cannulated Screw System will be indicated for use in long and small bone fracture fixation, which includes the following:
- Fractures of the tarsals and metatarsals .
- Fractures of the olecranon, distal humerous
- Fractures of the radius and ulna �
- Patella fractures ●
- Distal tibia and pilon fractures .
- Fractures of the fibula, medial malleolus, os calcis ●
- Tarso-metatarsal and metatarsal phalangeal arthrodesis .
- Metatarsal and phalangeal osteotomies
- Osteochondritis dissecans
- Ligament fixation
: 上一篇: 上一篇:
- Other small fragment, cancellous bone fractures and osteotomies
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)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K060428 |
|---|---|
| --------------- | --------- |