U1 HIP SYSTEM

K994078 · United Orthopedic Corp. · LPH · Dec 4, 2000 · Orthopedic

Device Facts

• Record ID: K994078
• Device Name: U1 HIP SYSTEM
• Applicant: United Orthopedic Corp.
• Product Code: LPH · Orthopedic
• Decision Date: Dec 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

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: 1. 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.

Device Story

The U1 Hip System is a modular total hip joint replacement prosthesis. Components include a tri-wedge femoral stem (cast Co-Cr-Mo alloy, ASTM F75) with porous-coated proximal surface and Morse taper; a 26mm femoral head (wrought Co-Cr-Mo alloy, ASTM F1537); a hemispherical acetabular shell (cast Co-Cr-Mo alloy) with porous coating and screw holes; and a UHMWPE liner. The device is implanted by orthopedic surgeons in a clinical/hospital setting to replace the hip joint. It functions as a mechanical load-bearing implant to restore joint function and reduce pain. Clinical benefit is derived from the restoration of hip biomechanics and stability.

Clinical Evidence

Bench testing only. Finite element analysis was performed to evaluate stem performance (relative motion, load transfer). Porous coating characterization included static tensile and shear strength testing (results >20MPa), volume porosity (30-70%), pore size (100-1000 microns), and coating thickness (500-1500 microns).

Technological Characteristics

Modular hip prosthesis. Materials: Cast Co-Cr-Mo alloy (ASTM F75) for femoral stem and acetabular shell; wrought Co-Cr-Mo alloy (ASTM F1537) for femoral head; UHMWPE (ISO 5834/1) for liner. Features: Tri-wedge femoral stem, Morse taper, beaded porous coating, hemispherical acetabular shell with screw holes. Sterilization method not specified.

Indications for Use

Indicated for skeletally mature patients requiring hip arthroplasty for pain relief or improved function due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity, revision procedures, or proximal femur fractures (nonunion, femoral neck, trochanteric) with head involvement.

Regulatory Classification

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.

Predicate Devices

• DePuy AML® Hip Prosthesis

Submission Summary (Full Text)

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# 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.

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#### 9 U1 HIP SYSTEM

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.

### 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.

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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, [phone]. Traditionally, and [phone]. 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 [phone] or at [phone], 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