(81 days)
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No
The summary describes a mechanical bone screw and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a permanent internal implant used for transposition of the anterior tibial tuberosity, indicating a direct therapeutic function to treat a medical condition or provide structural support for healing.
No
Explanation: The device is described as a "single-use, permanent internal device" and a "partially threaded screw" made of surgical implant Titanium, intended for "Transposition of Anterior Tibial Tuberosity." This indicates it is a surgical implant used for treatment, not for diagnosing a condition.
No
The device description clearly states it is a "single-use, permanent internal device" which is a physical screw made of titanium. This is a hardware device, not software.
No, 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 provided description clearly states this is a "single-use, permanent internal device" that is a "Flat-headed, partially threaded screw." It's designed to be implanted into the body.
- Intended Use: The intended use is for "Transposition of Anterior Tibial Tuberosity," which is a surgical procedure involving bone.
This device is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
Transposition of Anterior Tibial Tuberosity Possibility of compression without adding any washer.
Product codes
KWC
Device Description
This is a single-use, permanent internal device. This is a Flat-headed, partially threaded screw, designed to be used without any washer. This screw is available in six sizes : (40, 45, 50, 55 and 60 mm). This screw is madeof surgical implant Titanium, Ti6Al4EVELI, according to ASTM-136-92 or to ISO 5832-3-90.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Anterior Tibial Tuberosity
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
SUMMARY OF SAFETY AND EFFECTIVENESS
Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory authority : Company : J.B.S Parc d'activités Savipol 10000 Ste Savine, Troyes Tel : 011-33-2571-2500 MAR - 4 1996 Fax : 011-33-2571-2506 Medical Device Establishment Registration # : 9681258 FDA Owner/Operator # : 9021265 Contact : Mrs Liza Burns, Regulatory consultant. Trade name : J.B.S T.T.A screw Common name : T.T.A screw Classification : Bone, fixation, screw Classification Code : 87 KWC. Device description : This is a single-use, permanent internal device. This is a Flat-headed, partially threaded screw, designed to be used without any washer. This screw is available in six sizes : (40, 45, 50, 55 and 60 mm). This screw is madeof surgical implant Titanium, Ti6Al4EVELI, according to ASTM-136-92 or to ISO 5832-3-90.
Indications or use :
Transposition of Anterior Tibial Tuberosity Possibility of compression without adding any washer.
Contraindications :
The J.B.S T.T.A is not to be used for patients with active localized or systemic intection, patients who are pregnant or patients who have disease or other medical condition which inhibits the potential of bony fusion. (i.e., osteoporosis, kidney analysis, etc.).
Substantially equivalent devices .
1 - The partially threaded bone screw manufactured by Howmedica, Inc.
2-The partially threaded bone screw manufactured by Synthes.
Distributed by J.B.S USA 204E Blithedale Avenue Mill Valley. CA 94941
Made in France by J.B.S Parc d'activités Savipol 10300 Ste Savine, Troyes.