(28 days)
No
The device description and performance studies focus on the mechanical properties and materials of the hip implant components. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for the reduction or relief of pain and/or improved hip function, which constitutes a therapeutic purpose.
No
The device is a U2 Hip System which is a prosthesis used in hip arthroplasty to replace hip components. It is an implantable medical device, not a diagnostic one.
No
The device description clearly outlines physical components made of metal and polymer, intended for surgical implantation. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for surgical implantation to replace a hip joint. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose diseases or conditions.
- Device Description: The device is a physical implantable prosthesis made of metal and polymer components designed to function as a hip joint. This is consistent with a surgical implant, not an IVD.
- Performance Studies: The performance studies described are mechanical bench tests evaluating the physical properties and durability of the implant components. IVD performance studies typically involve clinical trials or analytical studies to assess the accuracy and reliability of the diagnostic results.
- Anatomical Site: The anatomical site is the hip, which is where the implant is placed within the body.
In summary, the device is a surgical implant for hip replacement, which is a medical device but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
For use as a Total Hip Replacement
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
For use as a Bipolar Hip Replacement
- Femoral head/neck factures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Cemented stem is designed for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI
Device Description
for hip arthroplasty is a metal/polymer/metal System designed U2 Hip semi-constrained prosthesis with femoral components and acetabular components. The femoral components are composed of a ball mechanical locked with a stem by means of a Morse taper, while the acetabular components are composed of an highly crosslinked ultra - high - molecular - weight - polyethylene articulating bearing surface fixed in a metal shell. Components of this premarket notification include the following components:
- Ti Porous Coated Cup
- XPE Cup Liner
- 32 mm and 36 mm Femoral Head
- U2 Hip Stem, Press-fit
- U2 Hip Stem, Cemented
The titanium bar (ASTM F136) was forged into a net-shape of acetabular cup and then the forged part was machined into the final shape of Ti Porous Coated Cup. The outer surface is ' porous coated with three layers of CP Ti beads (ASTM F1580). XPE Cup Liner is manufactured from highly crosslinked UHMWPE which conform to ASTM F2565 and the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834. The first series of XPE Cup Liner with the sizes of 44 to 80 mm has an inner diameter of 28 mm. The second series with the sizes of 50 to 80 mm have an inner diameter of 32 mm. The third series with the sizes from 54 to 80 mm have an inner diameter of 36 mm. The 32 and 36 mm Femoral Head is manufactured from CoCrMo alloy (ASTM F1537) with neck length of -3, +0, +5, and +10 mm. U2 Press-fit Stem is manufactured from titanium alloy (ASTM F620) which is intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. U2 Cemented Hip Stem manufactured from forging CoCrMo alloy (ASTM F799) is intended for cement fixation. Moreover, this device is available to use with an accessory, called "Cement Restrictor, Full PE" made of Ultra-High Molecular Weight Polyethylene (ASTM F648).
The Ti Porous Coated Cup will be used with 510k cleared cup liner of the U2 Acetabular Component (K050262) and currently submission XPE Cup Liner. As using with the existing cup liner (K050262), the Ti Porous Coated Cup may be used with 26 mm and 28 mm Femoral Head (K994078 and K022520) and 28 mm Ceramic Femoral Head (K103479). As using with currently submission XPE Cup Liner, this component may be used with currently submission 32 mm and 36mm Femoral Head, the 28 mm Femoral Head (K022520) and 28 mm and 32 mm Ceramic Femoral Head (K103479). Besides, XPE Cup Liner may also be used with existing U2 Acetabular Cup (K050262). The 32 mm and 36 mm Femoral Head may also be used with U2 Bipolar Implant (K101670), Revision Stem (K062978) and current submission Cemented Stem and Press-fit Stem
The Press-fit Stem and Cemented Stem will be used with currently submission 32mm and 36 mm metal Femoral Head and may be used with 26 mm and 28 mm metal Femoral Head (K994078 and K022520). The Press-fit Stem which made from Ti alloy can also be used with Ceramic Femoral Head (K103479).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
skeletally mature patients
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)
Performance Test - Bench:
This 5101k) was prepared in accordance with the Agency's, "Class II Special Controls Guidance Document- Hip Joint Metal Polymer Constrained Cemented or Uncemented Prosthesis", "Guidance for Non-clinical Information for Femoral Stem Prostheses", "Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components" and "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement". A review of the mechanical data indicates that the U2 Hip System is capable of withstanding expected in vivo loading without failure. The following mechanical tests of the U2 Hip System were performed:
- Locking Strength of XPE Cup Liner per ASTM F1820
- Wear Simulation Test of XPE Cup Liner per ISO 14242-1
- Range of Motion for XPE Cup Liner and 32 and 36 mm Femoral Head by CAD simulation
- Femoral Head Disassembly loads for the Subject Stem per ASTM F2009.
- Stem Fatigue Test for Press-fit Stem and Cemented Stem with Torsion per ISO 7206-4 and ASTM F1612
- Neck Fatigue Test for Press-fit Stem and Cemented Stem with Torsion per ISO 7206-6
- Evaluation of modified surface treatment includes SEM evaluation per ASTM F1854, shear fatigue testing per ASTM F1160, static shear testing per ASTM F1044, static tensile testing per ASTM F1147, and taber abrasion resistance per ASTM F1978
- Characterize of material properties of XPE cup liner includes tensile properties per ASTM D638, ultimate load per ASTM F2183, Izod impact strength per ASTM F648, Annex 1, fatigue crack propagation per ASTM E647, thermal properties (i.e. % crystallinity and melting temperature) per ASTM D3418, residual free radicals via ESR, swell ratio per ASTM F2214, oxidation index (OI) per ASTM F2102, and trans-vinylene index (TVI) per ASTM F2381.
A review of these tests has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
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.
K070756, K993352, K022520, K994078, K061066, K990369, K001733
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.
K050262, K994078, K022520, K103479, K101670, K062978
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
§ 888.3358 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.
0
( U2 Hip System
510(k) Summary
510(k) Summary of Safety and Effectiveness
| Submitted by: | United Orthopedic Corporation | |||
|---|---|---|---|---|
| Address: | No.57, Park Ave 2, Science Park, Hsinchu 300, Taiwan | |||
| Phone Number: | +886-3-5773351 ext. 212 | |||
| Fax Number: | +886-3-577156 | |||
| Date of Summary: | June 01, 2011 | |||
| Contact Person: | Fang-Yuan Ho | |||
| Manager, Regulatory Affairs | ||||
| Proprietary Name: | U2 Hip System | |||
| Common Name: | Semi-constrained total hip prostheses | |||
| Device Classification | ||||
| Name and Reference: | Hip joint metal/polymer/metal semi-constrained porous-coated | |||
| uncemented prosthesis under 21CFR 888.3358 | ||||
| This falls under the Orthopedics panel. | ||||
| Device Class | Class II | |||
| Panel Code | Orthopaedics Device | |||
| Device Product Code: | LPH, JDI | |||
| Predicate Device: | 1. "Smith & Nephew" R3 Acetabular Cup System (K070756) |
- "UNITED" Femoral Head (K022520, K994078)
- "Osteonics" Crossfire System Acetabular Insert (K993352)
- "Smith & Nephew" Synergy Hip System-Press Fit (K061066)
- "Smith & Nephew" Synergy Cemented Hip Stem (K990369)
- "Zimmer" Intramedullary Bone Plug (K001733) | | | |
Device Description:
for hip arthroplasty is a metal/polymer/metal System designed U2 Hip
1
ਤ U2 Hip System
semi-constrained prosthesis with femoral components and acetabular components. The femoral components are composed of a ball mechanical locked with a stem by means of a Morse taper, while the acetabular components are composed of an highly crosslinked ultra - high - molecular - weight - polyethylene articulating bearing surface fixed in a metal shell. Components of this premarket notification include the following components:
-
Ti Porous Coated Cup
-
XPE Cup Liner
-
32 mm and 36 mm Femoral Head
-
U2 Hip Stem, Press-fit
-
U2 Hip Stem, Cemented
The titanium bar (ASTM F136) was forged into a net-shape of acetabular cup and then the forged part was machined into the final shape of Ti Porous Coated Cup. The outer surface is ' porous coated with three layers of CP Ti beads (ASTM F1580). XPE Cup Liner is manufactured from highly crosslinked UHMWPE which conform to ASTM F2565 and the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834. The first series of XPE Cup Liner with the sizes of 44 to 80 mm has an inner diameter of 28 mm. The second series with the sizes of 50 to 80 mm have an inner diameter of 32 mm. The third series with the sizes from 54 to 80 mm have an inner diameter of 36 mm. The 32 and 36 mm Femoral Head is manufactured from CoCrMo alloy (ASTM F1537) with neck length of -3, +0, +5, and +10 mm. U2 Press-fit Stem is manufactured from titanium alloy (ASTM F620) which is intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. U2 Cemented Hip Stem manufactured from forging CoCrMo alloy (ASTM F799) is intended for cement fixation. Moreover, this device is available to use with an accessory, called "Cement Restrictor, Full PE" made of Ultra-High Molecular Weight Polyethylene (ASTM F648).
The Ti Porous Coated Cup will be used with 510k cleared cup liner of the U2 Acetabular
2