(56 days)
K 945303
Not Found
No
The 510(k) summary describes a purely mechanical, bioabsorbable screw for surgical fixation and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML devices.
Yes
The device is used for fixation of grafts during ACL/PCL reconstruction, which is a medical procedure to treat a damaged ligament, thus providing therapy.
No
The device description and intended use clearly state that it is a screw used for fixation in ACL/PCL reconstruction, which is a therapeutic purpose, not diagnostics.
No
The device description clearly states it is a physical screw made of polylactic acid, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a surgical implant used for fixing grafts during ACL/PCL reconstruction. It is a physical screw inserted into the body.
- Lack of Diagnostic Activity: There is no mention of testing samples, analyzing biological markers, or providing diagnostic information about a patient's condition.
This device falls under the category of a surgical implant or orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
Both screws have similar intended uses. The screws are used to fixate grafts to bone during anterior cruciate ligament reconstruction surgery. The Bioabsorbable is expanding that indication to soft-tissue.
Bioabsorbable Interference screw is used for fixation of bone-tendonbone or soft-tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
Indications:
-
- The Bioabsorbable Interference Screw is used for fixation of bone-tendon-bone or soft-tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
-
- The screw is indicated for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HWC, MAI
Device Description
The Bioabsorbable Interference Screw is a screw that has a range of diameters from 7 to 9 mm and a length that ranges from 20 mm to 30 mm. The Arthrex PLLA Bio-Screw is provided in a range of diameters from 7 to 9 mm and one length, 23 mm. The material of construction for both screws is polylactic acid.
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)
The Bioabsorbable Interference screw has been tested against the Arthrex PLLA Bio-Screw. Both screws had results which are recorded in the test results located in attachment one.
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.
K 945303
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
JAN 28 1999
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is : K984320
This summary was prepared on December 1, 1998
A. Submitter
Smith & Nephew, Inc., Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048
Company Contact B.
Demetrios Tsakonas Clinical/Regulatory Specialist
C. Device Name
| Trade Name: | Bioabsorbable Interference Screw |
|---|---|
| Common Name: | Screw, Fixation, Bone, Orthopedics |
| Classification Name: | Screw: 87HWC |
D. Predicate/Legally Marketed Devices
Arthrex Bio-Interference Screw (510K # K 945303) Arthrex, Inc. 3050 North Horseshoe Drive Naples, Florida
1
E. Device Description
The Bioabsorbable Interference Screw is a screw that has a range of diameters from 7 to 9 mm and a length that ranges from 20 mm to 30 mm. The Arthrex PLLA Bio-Screw is provided in a range of diameters from 7 to 9 mm and one length, 23 mm. The material of construction for both screws is polylactic acid.
F. Performance
The Bioabsorbable Interference screw has been tested against the Arthrex PLLA Bio-Screw. Both screws had results which are recorded in the test results located in attachment one.
G. Intended Use
Both screws have similar intended uses. The screws are used to fixate grafts to bone during anterior cruciate ligament reconstruction surgery. The Bioabsorbable is expanding that indication to soft-tissue.
H. Substantial Equivalence
The Bioabsorbable Interference Screw and the Arthrex PLLA have similar designs. Both are used in fixating grafts to bone. The material for both screws are the same and the screws have similar dimensions.
Risks to health have been addressed through the specified materials, processing controls, quality assurance, and compliance to the Medical Device Good Manufacturing Practices requlations.
A summary comparison of the characteristics of the Bioabsorbable Interference Screw and the substantially equivalent devices is presented in the table below.
| Current Product | Substantially Equivalent Product | |
|---|---|---|
| Attribute | ||
| ↓ | Bioabsorbable Interference Screw | Arthrex PLLA Bio-Screw |
| Indication | Bone-Tendon-Bone or Soft Tissue Graft | |
| Fixation for ACL/PCL | ||
| Reconstruction | Bone-Tendon-Bone or Soft Tissue Graft | |
| Fixation for ACL Reconstruction | ||
| Dimensions | Diameter: 7 - 9 mm | Diameter: 7 - 9 mm |
| Length: 20 - 30 mm | Length: 23 mm | |
| Material | PLA | PLA |
| Sterilization | Ethylene Oxide | NA |
| Labeling | Sterile, Single Use Only | NA |
| Applicant | Demetrios Jackson | |
| Date | 12/2/98 |
Applicant
Date 12/2/98
2
Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of a human figure embracing a globe. The emblem is positioned in the center of the circle. Encircling the emblem are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 28 1999
Mr. Demetrios Tsakonas Clinical/Requlatory Specialist Smith & Nephew Endoscopy 130 Forbes Boulevard Mansfield, Massachusetts 02048
K984320 Re : Bioabsorbable Interference Screw Trade Name: Requlatory Class: II Product Codes: HWC and MAI Dated: December 2, 1998 Received: December 3, 1998
Dear Mr. Tsakonas:
We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Demetrios Tsakonas
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
510 (k) Number (If Known):
Device Name: Bioabsorbable Interference Screw
Intended Use: Bioabsorbable Interference screw is used for fixation of bone-tendonbone or soft-tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
Indications:
-
- The Bioabsorbable Interference Screw is used for fixation of bone-tendon-bone or softtissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
-
- The screw is indicated for single use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Picedo
Prescription Use
(Per 21 CFR 801.109)
or Over-The-Counter Use ______________________________________________________________________________________________________________________________________________________