(368 days)
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No
The description focuses on the mechanical design and materials of a hip replacement system, with no mention of AI or ML capabilities. The performance studies described are based on finite element analysis and material properties, not AI/ML model performance.
Yes
The device is indicated for the reduction or relief of pain and/or improved hip function, which are therapeutic outcomes.
No
This device is a total hip joint replacement, which is a therapeutic rather than a diagnostic device. Its purpose is to treat conditions by replacing the hip joint, not to identify or characterize medical conditions.
No
The device description clearly outlines multiple hardware components made of metal alloys and plastic (Femoral Stem, Femoral Head, Acetabular Component, Bone Screw). This is a physical implant system, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a hip joint to relieve pain and improve function in patients with specific hip conditions. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device description details the components of a hip replacement system (femoral stem, femoral head, acetabular component, bone screw). These are physical implants designed to be surgically placed in the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- Performance Studies: The performance studies described involve finite element analysis and testing of the physical properties of the implant materials and coatings, not the analysis of biological samples.
In summary, this device is a surgical implant used for treatment, not a diagnostic tool used to analyze biological samples.
N/A
Intended Use / Indications for Use
The U1 hip system is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: Non-inflammatory degenerative joint disease such as osteoathritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. Inflammatory degenerative joint disease such as rheumatoid arthritis; 3. Correction of function deformity; 4. Revision procedures where other treatments or devices have failed; and 5. Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Product codes (comma separated list FDA assigned to the subject device)
LPH
Device Description
The U1 Hip System is designated as a total hip joint replacement. It is a modular type of product system. The followings are the major design features.
Femoral Stem: The component has seven sizes of options, tri- wedge design, straight stem, 1340 neck-stem angle, a Morse type taper to receive modular heads, porous coated surface on proximal portion and satin finished on distal. There are w/ and w/o calcar collar designs. This device is produced from cast Co-Cr-Mo alloy (ASTM F75).
Femoral Head; The head diameter is 26mm. There are four adjustments of options. Std. +3, +6, +9, respectively. It is fabricated from wrought Co-Cr-Mo alloy bars (ASTM F1537) by machining.
Acetabular Component: This device has ten sizes of options, hemispherical design, porous coated surface on metallic shell, clustered bone screw holes, spherical screw holes for variable screw locking angle, PMMA cement plug, easy snap-in and take out mechanism, 16 options for angle adjustment, minimum 4.33mm thickness of UHMWPE liner. The metallic shell is produced from cast Co-Cr-Mo alloy (ASTM F75). The plastic liner is machined from extruded UHMWPE bars (ISO 5834/1)
Bone Screw: This device is a 6.5 mm cancellous bone screw. It has six lengths of options (15 mm ~ 40 mm), and has a shallow screw head.
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
Hip joint
Indicated Patient Age Range
skeletally mature patients
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Ul stem was analyzed using finite element analysis. The results for the U1 stem (relative motion, load transfer, etc.) are somewhat less sensitive to changes in friction condition than they are for the more extensively coated AML. The analysis establishes the essential equivalence of the design concepts for the U1 and AML femoral components.
The static tensile and shear strength of the beaded porous coating are more than 20MPa. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1000 microns and a porous coating thickness between 500 and 1,500 microns.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
DePuy AML® Hip Prosthesis
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.
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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).
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§ 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
X994078
DEC = 4 2000
ਹੈ U1 HIP SYSTEM
Summary
510(k) Summary of Safety and Effectiveness
| Company: | United Orthopedic Corporation |
|---|---|
| Address: | No 57, Park Ave. 2, Science Park, Hsinchu, 300, Taiwan |
| Phone Number: | 886-3-5773351 |
| Fax Number: | 886-3-5777156 |
| Date Prepared: | November 16, 1999. |
| Device Name: | U1 Hip System |
| Common Name: | Hip joint prostheses or replacement |
Hip joint, Semi-Constrained, Metal/Polymer, Porous Classification Name: Uncemented Prosthesis per 21CFR 888.3358. DePuy AML® Hip Prosthesis Predicate Device:
Device Description:
The U1 Hip System is designated as a total hip joint replacement. It is a modular type of product system. The followings are the major design features.
Femoral Stem: The component has seven sizes of options, tri- wedge design, straight stem, 1340 neck-stem angle, a Morse type taper to receive modular heads, porous coated surface on proximal portion and satin finished on distal. There are w/ and w/o calcar collar designs. This device is produced from cast Co-Cr-Mo alloy (ASTM F75).
Femoral Head; The head diameter is 26mm. There are four adjustments of options. Std. +3, +6, +9, respectively. It is fabricated from wrought Co-Cr-Mo alloy bars (ASTM F1537) by machining.
Acetabular Component: This device has ten sizes of options, hemispherical design, porous coated surface on metallic shell, clustered bone screw holes, spherical screw holes for variable screw locking angle, PMMA cement plug, easy snap-in and take out mechanism, 16 options for angle adjustment, minimum 4.33mm thickness of UHMWPE liner. The metallic shell is produced from cast Co-Cr-Mo alloy (ASTM F75). The plastic liner is machined from extruded UHMWPE bars (ISO 5834/1)
Bone Screw: This device is a 6.5 mm cancellous bone screw. It has six lengths of options (15 mm ~ 40 mm), and has a shallow screw head.
Intended Use:
The U1 hip system is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: Non-inflammatory degenerative joint disease such as osteoathritis, avascular necrosis, 1.
1
9 U1 HIP SYSTEM
ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- Inflammatory degenerative joint disease such as rheumatoid arthritis;
-
- Correction of function deformity:
-
- Revision procedures where other treatments or devices have failed; and
-
- Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Basis for Substantial Equivalence:
Features comparable to predicate devices, DePuy AML® Hip prosthesis, include Co-Cr-Mo alloy substrate, straight type stem, beaded porous coated surface on the proximal portion of stem and acetabular cup, and Morse taper locked with heads.
Test Results:
The Ul stem was analyzed using finite element analysis. The results for the U1 stem (relative motion, load transfer, etc.) are somewhat less sensitive to changes in friction condition than they are for the more extensively coated AML. The analysis establishes the essential equivalence of the design concepts for the U1 and AML femoral components.
The static tensile and shear strength of the beaded porous coating are more than 20MPa. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1000 microns and a porous coating thickness between 500 and 1,500 microns.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4. 2000
Mr. Mellen Liu Regulatory Affairs Coordinator United Orthopedic Corporation 57, Park Avenue 2, Science Park Hsinchu 300, Taiwan, R.O.C.
Re: K994078/S1 Trade Name: U1 Hip System Regulatory Class: II Product Code: LPH Dated: September 8, 2000 Received: September 11, 2000
Dear Mr. Liu:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have and we have determined the device is substantially equivalent (for the indications for use above and we have actering as marketed in interstate commerce prior to May 28, 1976, the stated in the enorours) to teater with the enterest that have been reclassified in enacificin and of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, controls pro horons or use, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarket ripps of ally ware found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspotions, the Food and Diam may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 - Mr. Mellen Liu
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific arrivitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for m. Pro aluguestions on the promotion and advertising of your device, (201) 594-4639. Traditionally, and (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). "Other general information on your responsibilities under the Act may be obtained from the Division of Small monmation on your responsive at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Narls N Milburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
、 4 . . . . 1000
Enclosure
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510 (k) Number (if known):____________________________________________________________________________________________________________________________________________________
Device Name: _U1 Hip System
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:
- · Non-inflammatory degenerative joint disease such as osteoathritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- · Inflammatory degenerative joint disease such as rheumatoid arthritis;
- . Correction of function deformity;
- Revision procedures where other treatments or devices have failed; and .
- · Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation
Prescription Use __ (per 21 CFR 801.109) OR
Over-The Counter Use
for Mich N. Milliken
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K994078