(189 days)
This device is indicated for use in total hip arthroplasty or bipolar arthroplasty undergoing primary and revision surgery for the following conditions:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia
- Inflammatory degenerative joint disease such as rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
- Revision procedures where other treatments or devices have failed
UTF Stem is designed for cementless use.
UTF Stem is a modular, wedge-shaped stem with 12/14 neck taper, which is made from forging Ti-6A1-4V alloy conforming to ASTM F 620 and the proximal part of each femoral stem is coated with CP Ti plasma spray. The net-shape of stem was forged by the titanium bar (ASTM F136). Circumferential titanium plasma coating sprayed with CP Ti powder (ASTM F1580) provides biological fixation. This device is collarless to allow for self-seating of the implant between the lateral and medial cortices of the femoral canal. UTF Stem is available with standard offset and high offset options to restore hip biomechanics. Each type of offset is available in 10 sizes ranging.
For total hip replacement, UTF Stem can be used in conjunction with UNITED Femoral Head (K994078, K022520 and K111546), U2 Acetabular Cup Liner (K050262), XPE Cup Liner (K111546), U2 HA/Ti Plasma Spray Cup (K050262), U2 Ti Plasma Spray Cup (K050262) and U2 Ti Porous Coated Cup (K111546). As using with the U2 Acetabular Cup Liner (K050262), UTF Stem can be used with 26 mm and 28 mm Femoral Head (K994078 and K022520) and 28 mm ceramic Femoral Head (K103479). As using with XPE Cup Liner (K111546), UTF Stem can be used with 28 mm, 32 mm and 36 mm metal Femoral Head (K022520, K111546), and 28 mm and 32 mm Ceramic Femoral Head (K103479). Only U2 Ti Porous Coated Cup (K111546) and XPE Cup Liner (K111546) can be used in conjunction with the 32 mm and 36 mm Femoral Head (K111546, K103479). For bipolar hip replacement, UTF Stem also can be used in conjunction with 26 mm. 28 mm. 32mm and 36mm Femoral Head (K994078, K022520, K111546) and Bipolar implants (K050269, K101670). UNITED Femoral Head and Binolar Cap are made of Co-Cr-Mo alloy, while Ceramic Femoral Head is manufactured from alumina. Acetabular Cup Liner and Bipolar Cap Liner are made of UHMWPE, while U2 Acetabular Cup shells are manufactured from forged Titanium alloy.
The provided text describes a 510(k) summary for the "UTF Stem" total hip prosthesis. The acceptance criteria and supporting studies are limited to bench testing to demonstrate substantial equivalence to predicate devices. It does not contain information about clinical studies with human participants, expert review processes, or multi-reader multi-case studies.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance (Implied or Stated) |
|---|---|---|
| Mechanical Properties | Distal fatigue strength of UTF Stem | Performed (implies met relevant standards, though specific values are not presented) |
| Neck fatigue strength of UTF Stem | Performed (implies met relevant standards, though specific values are not presented) | |
| Femoral head disassembly loads for metal femoral head in conjunction with UTF Stem | Performed (implies met relevant standards, though specific values are not presented) | |
| Range of motion analysis | Performed (implies met relevant standards, though specific values are not presented) | |
| Burst test for ceramic femoral head with UTF Stem | Performed (implies met relevant standards, though specific values are not presented) | |
| Fatigue test for ceramic femoral head with UTF Stem | Performed (implies met relevant standards, though specific values are not presented) | |
| Burst test for post-fatigue for ceramic femoral head with UTF Stem | Performed (implies met relevant standards, though specific values are not presented) | |
| Rotational resistance test for ceramic femoral head with UTF Stem | Performed (implies met relevant standards, though specific values are not presented) | |
| Pull-off test for ceramic femoral head with UTF Stem | Performed (implies met relevant standards, though specific values are not presented) | |
| Material/Surface Properties | Evaluation of microstructure of the modified surface | Performed (implies met relevant standards, though specific details are not presented) |
Note: The document states that the 510(k) was prepared in accordance with several guidance documents, including "Class II Special Controls Guidance Document-Hip Joint Metal Polymer Constrained Cemented or Uncemented Prosthesis" and "Guidance for Non-clinical Information for Femoral Stem Prostheses." This implies that the tests performed adhered to the acceptance criteria outlined in these guidance documents, even if the specific numerical thresholds are not explicitly listed in this summary. The successful clearance by the FDA (K110245) indicates that the device was deemed to meet these criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions that the listed tests "have been performed." For bench testing, the sample size would typically refer to the number of physical samples of the device components tested for each specific test.
- Data Provenance: Not applicable in the context of clinical data. For bench testing, the data would originate from laboratory experiments conducted by the manufacturer or a contracted lab. The manufacturer is United Orthopedic Corporation, located in Hsinchu, Taiwan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. This summary only describes non-clinical, bench testing. There is no indication of a "ground truth" established by human experts for these mechanical or material property tests. The "ground truth" for bench tests is typically defined by engineering specifications, material standards (e.g., ASTM), and regulatory guidance documents.
4. Adjudication Method for the Test Set
- Not applicable. This summary pertains to non-clinical bench testing, where adjudication by multiple experts is not typically a component of determining test outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This document focuses solely on the substantial equivalence through bench testing (mechanical and material properties) of a hip prosthesis. It does not involve human readers or image interpretation, thus no MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical medical implant, not a software algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
- Engineering Specifications and Standardized Test Methods: The "ground truth" for the bench tests would be the established performance criteria and thresholds defined in relevant ASTM standards (e.g., ASTM F 620, ASTM F136, ASTM F1580), FDA guidance documents (e.g., "Guidance for Non-clinical Information for Femoral Stem Prostheses"), and the manufacturer's internal design specifications for a hip prosthesis.
8. The Sample Size for the Training Set
- Not applicable. This report describes the performance of a physical device, not an AI or machine learning model that would require a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, there is no training set for a physical medical device.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.