(107 days)
Not Found
Not Found
No
The description focuses solely on the material properties and mechanical design of a bioresorbable screw for orthopedic fixation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an implantable screw used for fixation of tendon transplants in cruciate ligament reconstruction, which is a therapeutic intervention.
No
The device is described as an interference screw used for fixation of tendon-transplants in knee ligament reconstruction. It mentions "diagnostic indications" but the purpose of the device itself is mechanical fixation and not diagnosis.
No
The device description clearly describes a physical, bioresorbable screw made of Poly (D,L-Lactide), which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "Tibial and femoral fixation (primary anchorage) of the autologous tendon-transplants... in the reconstruction of the cruciate ligaments of the human knee." This describes a surgical procedure and the use of an implant to fix tissue, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a bioresorbable interference screw used for physical fixation of a tendon graft. It talks about material properties, thread design, and implantation. This is characteristic of a surgical implant, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for structural support during a reconstructive procedure.
N/A
Intended Use / Indications for Use
The Sulzer Orthopedics Sysorb Interference Screws are intended for use in the following diagnostic indications:
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- Tibial and femoral fixation (primary anchorage) of the autologous tendon-transplants as it is used in the reconstruction of the cruciate ligaments of the human knee.
Product codes
MAI, HWC, GAT
Device Description
The Sulzer Orthopedics Sysorb Interference Screws are a bioresorbable interference screw used in attachment of autologous tendon tranfers in cruciate ligament reconstruction. The Sysorb interference screws are manufactured from the bioresorbable material Poly (D,L-Lactide) (Resomer R208), an amorphous polymer derivative of lactic acid. The screw provides an initial interference fit fixation of the tissue graft and resorbs over time as the graft is naturally incorporated into the surrounding structure.
The Sysorb Interference Screw uses a nearly symmetrical thread profile which takes into account both the strength of the material and the relative strength of cancellous bone. The design also allows the screw to be introduced without drilling or tapping. A continuous "turbine" shaped driving feature allows torque to be applied along the complete length of the screw upon implantation, thus minimizing the potential for fracture of the implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human knee (tibial and femoral fixation for cruciate ligaments)
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
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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)
Not Found
Reference Device(s)
Smith & Nephew (Acufex) Endo-Fix, Instrument Makar Biologically Quiet, Arthrex Bio-Interference, Linvatec Bioscrew
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) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Sulzer Orthopedics Sysorb Interference Screw.
| Submitter/
Author. Rep .: | Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 |
|------------------------------|-----------------------------------------------------------------------------------------|
| Manufacturer: | Sulzer Orthopedics Ltd.
Grabenstrasse 25
CH-6341 Baar, Switzerland |
| Date: | October 8, 1998 |
| Contact Person: | Mitchell A. Dhority, RAC
Manager, Regulatory Affairs |
| Classification Name: | 21 CFR 888.3040 - Smooth or threaded metallic bone fixation
fastener |
| Common/Usual Name: | Resorbable interference screw |
| Trade/Proprietary Name: | Sulzer Orthopedics Sysorb Interference Screw |
PRODUCT DESCRIPTION
The Sulzer Orthopedics Sysorb Interference Screws are a bioresorbable interference screw used in attachment of autologous tendon tranfers in cruciate ligament reconstruction. The Sysorb interference screws are manufactured from the bioresorbable material Poly (D,L-Lactide) (Resomer R208), an amorphous polymer derivative of lactic acid. The screw provides an initial interference fit fixation of the tissue graft and resorbs over time as the graft is naturally incorporated into the surrounding structure.
The Sysorb Interference Screw uses a nearly symmetrical thread profile which takes into account both the strength of the material and the relative strength of cancellous bone. The design also allows the screw to be introduced without drilling or tapping. A continuous "turbine" shaped driving feature allows torque to be applied along the complete length of the screw upon implantation, thus minimizing the potential for fracture of the implant.
SPECIFIC DIAGNOSTIC INDICATIONS
The Sulzer Orthopedics Sysorb Interference Screws are intended for use in tibial and femoral fixation (primary anchorage) of the autologous tendon-transplants as it is used in the reconstruction of the cruciate ligaments of the human knee.
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SUBSTANTIAL EQUIVALENCE
The Sulzer Orthopedics Sysorb Interference Screws are similar to the following competitive, commercially available resorbable interference screws:
- Smith & Nephew (Acufex) Endo-Fix 프
- Instrument Makar Biologically Quiet
- Arthrex Bio-Interference
- Linvatec Bioscrew
2
Image /page/2/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. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 28 1999
Mr. Mitchell A. Dhority Manager, Regulatory Affairs Sulzer Orthopedics Inc. 9900 Spectrum Drive Austin, Texas 78717
K983592 Re: SYSORB Resorbable Interference Screw Requlatory Class: II Product Codes: MAI, HWC, and GAT January 12, 1999 Dated: Received: January 14, 1999
Dear Mr. Dhority:
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 requlations 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 regulatory action. In addition, FDA may publish further announcements 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 requlations.
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Page 2 - Mr. Mitchell A. Dhority
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 regulation (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 Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to the regulation cherefox) hisbidian's ap sother 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,
Colin M. Hittle, Ph.D., M.D.
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
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Page 1 of 1
510(k) Number (if known): ___ 9 3 3 5 9 2
Device Name: Sulzer Orthopedics Sysorb Interference Screws
Indications For Use:
The Sulzer Orthopedics Sysorb Interference Screws are intended for use in the following diagnostic indications:
-
- Tibial and femoral fixation (primary anchorage) of the autologous tendon-transplants as it is used in the reconstruction of the cruciate ligaments of the human knee.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Acòelly
Division Sign-Off of General Restorat 510(k) Number