(11 days)
Not Found
Not Found
No
The summary describes a mechanical device (cannulated screws) with design modifications and mechanical testing, with no mention of software, image processing, or AI/ML terms.
No
This device is for fracture fixation, meaning it helps to stabilize and hold bones in place after a fracture, which is a supportive and reparative function rather than a direct therapeutic one like drug delivery or pain relief.
No
Explanation: The device is a cannulated screw system intended for fracture fixation, which is a treatment rather than a diagnostic function. It is a surgical implant and not designed to diagnose a condition.
No
The device description clearly states it is a "Cannulated Screw System" and describes modifications to screw lengths and diameters, indicating it is a physical hardware device used for fracture fixation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fracture fixation of small and long bones and of the pelvis." This describes a surgical implant used to stabilize broken bones within the body.
- Device Description: The description details design modifications to a "Cannulated Screw System," which is a type of orthopedic implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used for diagnostic purposes by analyzing samples outside the body. This device is clearly an implant used within the body for structural support.
N/A
Intended Use / Indications for Use
The intended use of the modified devices, as described in its labeling, has not changed as a result of this modification. These devices are intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
This Special 510(k) submission is intended to address design modifications to the Asnis III Cannulated Screw System. Additional lengths have been added to the 8.0 mm diameter screws. The core thread diameter of the 6.5 mm diameter screws has been modified. The material, intended use, packaging and sterilization of the subject devices are identical to those of predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small and long bones and of the pelvis
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)
Mechanical testing and analysis demonstrates comparable properties of the subject to the predicate device.
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.
Not Found
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
Special 510(k) Summary: Device Modification to the Asnis III Cannulated Screw System
| Submission Information | |
|---|---|
| Name and Address of the Sponsor | |
| of the 510(k) Submission: | Howmedica Osteonics Corp |
| 59 Route 17 | |
| Allendale, NJ 07401-1677 | |
| Contact Person: | Karen Ariemma |
| Regulatory Affairs Specialist | |
| Date of Summary Preparation: | December 6, 2002 |
| Device Identification | |
| Proprietary Name: | Asnis III Cannulated Screw System |
| Common Name: | Bone Screw |
| Classification Name and Reference: | Single/multiple component metallic bone fixation |
| appliances and accessories, 21 CFR §888.3030 |
This Special 510(k) submission is intended to address design modifications to the Asnis III Cannulated Screw System. Additional lengths have been added to the 8.0 mm diameter screws. The core thread diameter of the 6.5 mm diameter screws has been modified. The material, intended use, packaging and sterilization of the subject devices are identical to those of predicate devices.
Intended Use
The intended use of the modified devices, as described in its labeling, has not changed as a result of this modification. These devices are intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
Statement of Technological Comparison
Mechanical testing and analysis demonstrates comparable properties of the subject to the predicate device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Public Health Service
DEC 2 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Ariemma Regulatory Affairs Specialist Stryker Howmedica Osteonics Corp. 59 Route 17 South Allendale, New Jersey 07401-1677
Re: K024060 -
Trade Name: Asnis III Cannulated Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and
accessories
Regulatory Class: II Product Code: HWC Dated: December 6, 2002 Received: December 9, 2002
Dear Ms. Ariemma:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 – Ms. Karen Ariemma
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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,
Muriam C. Puvot
for 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
510(k) Number (if known): KO 2 40 60
Device Name: Asnis III Cannulated Screw System
Indications for Use
The Asnis III Cannulated Screw System intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use メ
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Number K029060