(458 days)
No
The summary describes a mechanical hip implant system and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are based on mechanical testing.
Yes
The device is a total hip replacement system, which replaces diseased or damaged hip joints to improve function and alleviate symptoms. These actions constitute a therapeutic intervention.
No
Explanation: The device is a total hip replacement system, specifically an acetabular component. Its purpose is to replace a diseased or damaged hip joint, not to diagnose a condition.
No
The device description clearly states that the TREGOR® Dual Mobility Acetabular System is composed of physical components like a metal acetabular cup/shell and a dual mobility polyethylene insert, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a hip prosthesis for total hip replacement surgery. This is a surgical implant, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details the physical components of a hip implant (acetabular cup, insert, coatings, etc.). It does not mention any reagents, calibrators, or other components typically associated with IVD devices.
- Performance Studies: The performance studies described are related to the mechanical and physical properties of the implant (static and fatigue loading, wear, coating characterization), not to the analysis of biological samples.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. This device is a medical device used in the body to replace a damaged hip joint.
N/A
Intended Use / Indications for Use
The TREGOR® Dual Mobility Acetabular System is indicated for hip pathologies requiring total hip replacement (THR):
- Non inflammatory or rheumatoid arthritis;
- Osteonecrosis of femoral head;
- Hip deformity affecting its function;
- Non-union head fracture or complex pertrochanteric fracture that are unmanageable using other techniques;
- Revision of previous hip surgery;
- Dislocation risks (e.g., ASA score ≥ 3)
The TREGOR® Dual Mobility Acetabular System hip prosthesis is intended for use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.
Product codes
LZO, MEH, LPH, JDI
Device Description
The TREGOR® Dual Mobility Acetabular System includes the acetabular components of a total hip prosthesis. Its design is based on the original 1976 Dual Mobility design developed by Prof. Bousquet: it uses two distinct articulating surfaces. The TREGOR® Dual Mobility Acetabular System is composed of a metal acetabular cup/shell and a dual mobility polyethylene insert. The articulating surfaces are: between the cup and the dual mobility insert, and between the dual mobility insert and the femoral head. The acetabular cup is made of wrought high nitrogen stainless steel (M30NW) for the cemented cup design (TREGOR® Medial Cup) and of Cobalt/Chromium alloy for all other cementless cup designs that are intended for a press-fit application. When used with cement, an acetabular reinforcement accessory with screws may also be used. When used without cement, the cup may include additional fixation aids (screws, pegs, blades) and includes a non-porous double coating. The plasma spray coating is made of pure titanium and hydroxyapatite (Ti/HA). The insert is made of ultra-high-molecular-weight polyethylene (UHMWPE).
There are five configurations of acetabular cups covering a wide range of sizes with dual mobility inserts compatible with 28 mm prosthetic femoral heads made of CrCo or ceramic:
- TREGOR® Standard (6 sizes from 52 to 62 mm outer diameter): Ti/HA coating, cementless and press fit application.
- TREGOR® 3 Blades (6 sizes from 52 to 62 mm outer diameter): Ti/HA coating, cementless and press fit application. Blades provide additional fixation.
- TREGOR® + (7 sizes from 52 to 64 mm outer diameter): Ti/HA coating, cementless and press fit application. Blades and screws provide additional fixation.
- TREGOR® Tripod (7 sizes from 52 to 64 mm outer diameter): Ti/HA coating, cementless and press fit application. Pegs and screw provide additional fixation.
- TREGOR® Medial Cup (5 sizes from 52 to 60 mm outer diameter): for cemented use only. An optional acetabular reinforcement cross is for cemented use only.
The device is single use and provided sterile.
This premarket notification does not include the femoral components. The TREGOR® Dual Mobility Acetabular System is compatible with FDA cleared StelKast femoral components: Provident, Protract and Progeny femoral stems with the femoral heads made of cobalt-chromium and ceramics, listed below. The femoral heads fully cover the morse taper of the femoral stem neck and the stems all have a polished, highly polished or electro-polished neck:
- Prosthetic head made of Cobalt-Chromium: 28 mm (StelKast reference SC1151: -5 mm, -3.5 mm, standard and +3.5 mm offset)
- Biolox Delta Femoral head: 28 mm (StelKast reference SC3347, -3.5 mm, standard and +3.5 mm offset)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Skeletally mature individuals
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)
Pre-clinical performance testing was conducted in accordance with various international standards and FDA guidance documents. The following tests were conducted:
- Dimensional and sizes analysis
- Static test of dual mobility insert dislocation pull-out
- Static test of dual mobility insert dislocation lever out
- Static and fatigue loading testing of the acetabular cup
- Range of motion analysis
- Jump distance analysis
- Holding of cemented cup under flexion and torsion loading
- Axial holding of tripod peg under loading
- Wear of polyethylene of dual mobility insert
- Dual Titanium and Hydroxyapatite coating characterization
All acceptance criteria were met.
Results concluded that the TREGOR® Dual Mobility Acetabular System finished product and its components met all pre-determined specifications and are adequate for their intended use.
Clinical data were not required for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K070278, K072020, K083116, K101336, Pre-Medical Device Amendment to Food, Drug and Cosmetic Act of 1976 - Charnley design acetabular cup
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
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