(17 days)
Not Found
No
The description focuses on the mechanical design and materials of a bone screw, with no mention of AI or ML capabilities.
Yes
The device is described as an implant used for the internal fixation of fractures, fusion, revision, and reconstructive procedures where reduction and fixation of bone fragments are required, which aligns with the definition of a therapeutic device.
No
The device description and intended use clearly state that the Kompressor compression screw is a fixation device used for the reduction and fixation of fractures, fusion, and reconstructive procedures. It is an implant that provides mechanical support, not a tool for diagnosis.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The Kompressor compression screw is a surgical implant used for the internal fixation of bone fractures. It is a physical device inserted into the body to stabilize bone.
- Intended Use: The intended use is for the reduction and fixation of fractures and reconstructive procedures involving bone. This is a therapeutic or surgical application, not a diagnostic one performed on a sample outside the body.
The description clearly indicates a device used within the body for structural support and fixation, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The use of the Kompressor compression screw is generally indicated for the reduction and fixation of fractures appropriate for the size of the device. It is indicated for use in the internal fixation of fractures, fusion, and revision. It is also indicated for reconstructive procedures where reduction and fixation of bone Iraleatou is required (e.g. osteotomies). Contraindications would (Aclude any conditions which would contraindicate implants in general, inclucing:
- Infection .
- Metal sensitivity or allergic reaction to foreign bodies J
- Any concomitant disease which may compromise the function of the ● imolant
- In those cases where avascular necrosis has rendered bone stock . inadequate
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Kompressor bone screw implant is a two-picce fixation device intended for use in the reduction, stabilization, and internal fixation of small bone fractures. The 2-picce design icaucilon, stabilization, and trailing screw component. The implant utilizes a mouporates the use of a reading and trailing portions of the screw to reduce and variance in thread phen between and le in a variety of sizes to accommodate various fracture types and sites.
Materials: Titanium; Ti-6A14V-ELI per ASTM F136 Materials: 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
Not Found
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)
Not Found
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.
Not Found
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
MAR - 1 2004
Modified KMI Kompressor Compression Screw System
For
-
- Submitter:
Kinetikos Medical, Inc. Suite 180 6005 Hidden Valley Rd. Carlsbad, CA 92009
- Submitter:
Contact Person:
K040356
page 1 of 1
John G. Spampinato V.P., Quality Assurance Kinetikos Medical, Inc. Suite 180 6005 Hidden Valley Road Carlsbad, CA 92009 FAX (760) 448 1739 (760) 448 1706
Date Prepared: Feb 10, 2004
| 2. Trade Name: | Kompressor Compression Screw System |
|---|---|
| Common Name: | Compression Screw |
| Classification Name: | Orthopedic |
3. Predicate or legally marketed devices which are substantially equivalent
-KMI Kompressor compression screw (K024233)
Description of Device 4.
Description of Device
The Kompressor bone screw implant is a two-picce fixation device intended for use in the reduction, stabilization, and internal fixation of small bone fractures. The 2-picce design icaucilon, stabilization, and trailing screw component. The implant utilizes a mouporates the use of a reading and trailing portions of the screw to reduce and variance in thread phen between and le in a variety of sizes to accommodate various fracture types and sites.
Materials: Titanium; Ti-6A14V-ELI per ASTM F136 Materials: The system functions to draw bone fractures together, thereby facilitating fixation.
5. Intended Use
The use of the Kompressor compression screw is generally indicated for the reduction and The use of the Rompressor vempression is is indicated for use in the internal fixation of fractures appropriate for the Silso indicated for reconstructive procedures where reduction and fixation of bone fragments is required (e.g. osteotomies). Contraindications would include any conditions which would contraindicate implants in general, including:
- Infection ◆
- Metal sensitivity or allergic reaction to forcign bodies .
- Mour concomitant disease which may compromise the function of the implant .
- In those cases where 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 modified Kompression Screw There are no sigmineant arreters systems currently being marketed which would adversely and the product. The modified Kompressor compression screw system employs affect the use of the produce. The predicate, legally marketed device in that the essential the same mechanical leatures as the preasurios tegared and a trailing thread, the varying ratios contiguration consists of a leading, son tapping may and bone segments. Changes were limited to: a new range of sizes and the indications for use have been broadened to include applications other than small bones of the hand and wrist.
1
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 2004
Mr. John Spampinato Vice President, Quality Assurance Kinetikos Medical, Inc. 6005 Hidden Valley Road, Suite 180 Carlsbad, California 92009
Re: K040356
Trade/Device Name: Kompressor Compression 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 10, 2004 Received: February 17, 2004
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.
2
Page 2 - Mr. John Spampinato
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
iriam C. Provost
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
Special 510(k) Notification - - Kompressor Compression Screw System
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 appropriate for the size of the device. It is indicated for use in the internal fixation of fractures, fusion, and revision. It is also indicated for reconstructive procedures where reduction and fixation of bone Iraleatou is required (e.g. osteotomies). Contraindications would (Aclude any conditions which would contraindicate implants in general, inclucing:
- Infection .
- Metal sensitivity or allergic reaction to foreign bodies J
- Any concomitant disease which may compromise the function of the ● imolant
- In those cases where avascular necrosis has rendered bone stock . inadequate
(PLEASE DO NOT WRITE BELOW THIS LINE - CONITINUE ON ANOTHER P. GE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| Miriam C. Provost | |
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| Over-the-Counter Use | __________ |
and Neurological Devices
510(k) Number K040356