(148 days)
No
The description focuses on the material and mechanical function of a surgical screw, with no mention of AI/ML, image processing, or data-driven analysis.
No
The device, BioScrew, is an absorbable interference screw used for fixation during ligament reconstruction. Its primary function is mechanical support, not direct treatment of a disease or condition, which is a characteristic of therapeutic devices.
No
The device is described as an interference screw used in ligament reconstruction, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states the BioScrew is a physical, absorbable bone screw made of Poly (L-lactic Acid), indicating it is a hardware device, not software.
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 and Intended Use: The BioScrew is a physical implantable device used for surgical fixation of grafts during ligament reconstruction. It is a screw made of absorbable material that is placed directly into the bone.
- Lack of Biological Sample Analysis: The description and intended use do not involve the analysis of any biological samples from the patient. The device's function is mechanical fixation within the body.
Therefore, the BioScrew falls under the category of a surgical implant or device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
- The BioScrew is used to provide interference 1. fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament reconstruction.
- The BioScrew is used to provide interference 2. fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
- The BioScrew is used to provide interference 3. fixation during posterior cruciate ligament reconstruction.
Implantation of the interference screw is accomplished through arthroscopy or arthrotomy. This device is a single-use device.
Product codes (comma separated list FDA assigned to the subject device)
HWC, MAI
Device Description
The BioScrew Absorbable Interference Screw is a cannulated, sterile, single-use bone screw made of an absorbable homopolymer derived from Poly (L-lactic Acid) similar to that used in bioabsorbable suture and will gradually be absorbed into the body.
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)
Strength and degradation tests are planned to compare the BioScrew to the Arthrex and/or BioMet screws.
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.
Linvatec BioScrew Absorbable Interference Screw, Arthrex Interference Screws, Arthrotek Interference Screws, K960652, K960940, K915424, K934469
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
Image /page/0/Picture/1 description: The image shows the logo for Linvatec. The logo consists of a geometric shape on the left and the word "Linvatec" on the right. The geometric shape is a square with three lines inside, and the word "Linvatec" is in a bold, sans-serif font.
11311 Concept Boulevard - Largo, Florida - 3773 - 813 399-5334 - Fax 813 399-5264
Carol A. Weideman, Ph.D.
Director Regulatory Affairs
Image /page/0/Picture/5 description: The image shows a handwritten string of characters. The string appears to be "K973758". The characters are written in black ink on a white background. The numbers are slightly uneven and have a handwritten style.
October 1, 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
BioScrew® Absorbable Interference Screw
In accordance with the requirements of the Safe Medical In accordance #1ch and 21 CFR 807.92, Linvatec Corporation Device Hot of itting the 510(k) Summary of Safety and Absorbable Interference Effectiveness for the BioScrew® Screw.
Submitter A.
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773
Company Contact B.
Carol A. Weideman, Ph.D. Director, Regulatory Affairs
Device Name C.
BioScrew® Absorbable Interference Screw Trade Name : Bone Screw Common Name: Smooth or threaded metallic bone Classification Name: fixation fastener
Predicate/Legally Marketed Devices D.
Linvatec BioScrew Absorbable Interference Screw Arthrex Interference Screws Arthrotek Interference Screw
Device Description E .
The BioScrew Absorbable Interference Screw is a cannulated, sterile, single-use bone screw made of an absorbable homopolymer derived from Poly (L-lactic Acid) similar to that used in bioabsorbable suture and will gradually be absorbed into the body.
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1
Summary of Safety and Effectiveness BioScrew® Absorbable Interference Screw 510 (k) # _ K973758 October 1, 1997 Page 2 of 3
Intended Use F.
- The BioScrew is used to provide interference 1. fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament reconstruction.
- The BioScrew is used to provide interference 2. fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
- The BioScrew is used to provide interference 3. fixation during posterior cruciate ligament reconstruction.
Implantation of the interference screw is accomplished through arthroscopy or arthrotomy. This device is a single-use device.
Substantial Equivalence G.
The BioScrew Absorbable Interference Screw is substantially equivalent in design, function and intended use to Linvatec BioScrew Absorbable Interference Screw, Arthrex Interference Screws and Arthrotek Interference Screws.
Strength and degradation tests are planned to compare the BioScrew to the Arthrex and/or BioMet screws.
The similarities/dissimilarities to the predicate are shown in the attached table.
2
CHART OF SIMILARITIES AND DISSIMILARITIES
(
| Company Name | Device Name | Intended Use | Material | Single-Use
Reusable | Method of
Sterilization | Design |
|-------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------|
| New Product
Invatec | BioScrew®
Absorbable
Interference
Screw | Provide interference fixation:
- Patellar bone-tendon-bone
grafts in ACL reconstruction - Femoral and/or tibial
fixation in ACL
reconstruction using a soft
tissue graft - PCL reconstruction | Poly
(L-lactic Acid) | Sterile
Single-use | Ethylene
Oxide
24 month
shelf life | Cannulated
Headless & rounded
head
Diameter: 7mm-11mm
Length: 20mm-30mm |
| Predicate
Invatec | BioScrew®
Absorbable
Interference
Screw
510(k) #K960652
#K960940 | Provide interference fixation: - Patellar bone-tendon-bone
grafts in ACL reconstruction - Femoral and/or tibial
fixation in ACL
reconstruction using a soft
tissue graft - PCL reconstruction | Poly
(L-lactic Acid) | Sterile
Single-use | Ethylene
Oxide
24 month
shelf life | Cannulated
Headless and rounded
head
Diameter: 7mm-9mm
Length: 20mm-30mm |
| Predicate
Arthrex,
Inc. | Non-sheathed
Interference
Screws
Full Threaded
Screws
510(k) #K915424 | Tibial ACL fixation, PCL
femoral and tibial fixation and
standard two incision type ACL
procedures | Titanium | Sterile
Single-use | Unknown | Cannulated
Headless and rounded
head
Diameter: 6mm-10mm
Length: 20mm-30mm |
| Predicate
BioMet,
Inc. | Arthrotek
Interference
Screw
510(k) #K934469 | Interference fixation ACL and
PCL reconstruction | Titanium | Sterile or
non-sterile
Single-use | Unknown | Rounded head
Diameter: 7mm-10mm
Length: 20mm-30mm |
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB