(45 days)
Not Found
No
The 510(k) summary describes a mechanical bone screw and does not mention any AI or ML components or functions.
Yes
The device is described as an implant used for the reduction and fixation of bone fractures, which is a therapeutic intervention.
No
Explanation: The device is described as a surgical implant (bone screw) used for the reduction and fixation of bone fractures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical bone screw implant made of titanium, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Kompressor compression screw is a surgical implant designed for the mechanical fixation of bone fractures. It is used within the body to stabilize bone fragments.
- Intended Use: The intended use clearly states its purpose is for the "reduction and fixation of fractures of the small bones of the hand and wrist." This is a surgical intervention, not a diagnostic test performed on a sample.
The device's function is mechanical stabilization of bone, which is fundamentally different from the diagnostic analysis of biological samples.
N/A
Intended Use / Indications for Use
The use of the Kompressor compression screw is generally indicated for the reduction and fixation of fractures of the small bones of the hand and wrist, such as the scaphoid. It is indicated for use in the fixation of fractures classified as acute or fresh, as well as cases of non-union where conservative treatment options have failed.
Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.
Product codes
HWC
Device Description
The Kompressor bone screw implant is a two-piece fixation device intended for use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fıx fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.
Materials: Titanium; Ti-6A14V-ELI as per ASTN F136
Function: The system functions to draw bone fractures together, thereby facilitating fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of the hand and wrist, such as the scaphoid
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
Not Found
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
APPENDIX I SUMMARY OF SAFETY AND EFFECTIVENESS
For
Kompressor Compression Screw System
-
- Submitter:
Contact Person:
FEB 0 6 2003
Kinetikos Medical, Inc. 6005 Hidden Valley Rd. Carlsbad, CA 92009
John G. Spampinato V.P., Quality Assurance Kinetikos Medical, Inc. 6005 Hidden Valley Road Carlsbad, CA 92009 (858) 558 2233 # 406 FAX (858) 558 0838
Date Prepared: December 19, 2002
| 2. Trade Name: | Kompressor Compression Screw System | |
|---|---|---|
| Common Name: | Compression Screw | |
| Classification Name: | Orthopedic |
4. Description of Device
The Kompressor bone screw implant is a two-piece fixation device intended for use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fıx fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.
Materials: Titanium; Ti-6A14V-ELI as per ASTN F136
Function: The system functions to draw bone fractures together, thereby facilitating fixation.
5. Intended Use
The use of the Kompressor compresion screw is generally indicated for the reduction and fixation of fractures of the small bones of the hand and wrist, such as the scaphoid. It is indicated for use in the fixation of fractures classified as acute or fresh, as well as cases of non-union where conservative treatment options have failed.
Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.
Comparison of technological characteristics of the device to predicate and legally 6. marketed devices:
There are no significant differences between the Kompressor Compression Screw and other systems currently being marketed which would adversely affect the use of the product. The Kompressor compression screw employs the same basic mechanical features as the predicate, legally marketed devices specified in section I in that the essential configuration consists of a leading, self-tapping thread and a trailing thread, the varying ratios of which result in the desired compression of the fractured bone segments.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 6 2003
Kinetikos Medical, Inc. John G. Spampinato Vice President, Ouality Assurance 6005 Hidden Valley Road Carlsbad, California 92009
Re: K024233
Trade/Device Name: Kompressor Screw System Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 19, 2002 Received: December 23, 2002
Dear Mr. Spampinato:
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. 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
2
Page 2 - Mr. John G. Spampinato
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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark McMullen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of of 1
510(k) Number: K024233
Device Name: Kompressor Compression Screw System
Indications For Use:
The use of the Kompressor compression screw is generally indicated for the reduction and fixation of fractures of the small bones of the hand and wrist, such as the scaphoid. It is indicated for use in the fixation of fractures classified as acute or fresh, as well as cases of non-union where conservative treatment options have failed.
Use of the implant is contraindicated in those cases where complex avascular necrosis has rendered bone stock inadequate.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| for (Division Sign-Off) | |
|---|---|
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K024233 |
| Prescription Use (Per 21 CFR 801 109) | OR | Over The Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)