ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES

K965156 · Johnson & Johnson Professionals, Inc. · KWL · Jan 24, 1997 · Orthopedic

Device Facts

• Record ID: K965156
• Device Name: ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES
• Applicant: Johnson & Johnson Professionals, Inc.
• Product Code: KWL · Orthopedic
• Decision Date: Jan 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ULTIMA* Unipolar Head is indicated for use in conjunction with a modular femoral stem in partial hip replacement procedures for patients suffering severe pain and disability due to: 1. femoral neck fracture, 2. avascular necrosis of the femoral head, 3. osteoarthritis, 4. abnormalities where: - the major pathology affects the femoral head, - the acetabular cavity is normal and not deformed or weakened, - acetabular replacement is not required or desirable.

Device Story

ULTIMA* Unipolar Head and Adapter Sleeves are metallic hip prostheses for partial hip replacement. Device consists of a cobalt-chromium-molybdenum (Co-Cr-Mo) unipolar head (38mm-63mm) and modular adapter sleeves. Heads are either solid (38-43mm) or hollow two-piece electron-beam welded assemblies (44-63mm). Adapter sleeves provide various neck length offsets (10/12, 11/13, 12/14 tapers) to interface with modular femoral stems via Morse-taper locking. Used by orthopedic surgeons in clinical settings to restore hip function in patients with femoral head pathology but healthy acetabula. Benefits include restoration of joint articulation and pain relief.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Cast Co-Cr-Mo alloy (ASTM F75) for heads; wrought Co-Cr-Mo alloy (ASTM F799) for adapter sleeves. Manufacturing: Hot isostatic pressing, solution annealing, electron beam welding (for hollow heads). Design: Unipolar head with tapered bore for modular adapter sleeves. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring partial hip replacement due to femoral neck fracture, avascular necrosis of the femoral head, or osteoarthritis, where the acetabulum is normal and does not require replacement.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• ULTIMA* Unipolar Modular Head (not specified)
• Howmedica Unitrax Unipolar System (not specified)

Submission Summary (Full Text)

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R965156
JAN 24 1997

# Summary of Safety & Effectiveness Data for the ULTIMA* Unipolar Head and Adapter Sleeves

Johnson & Johnson Professional, Inc.
325 Paramount Drive
Raynham, Massachusetts 02767

1. Contact Person

Johanna Newman, Assoc. Regulatory Affairs Specialist, [phone].

2. Device Name

Proprietary Name: ULTIMA* Unipolar Head and Adapter Sleeves
Common Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis
Classification Name: Prosthesis, Hip
Regulatory Class: Class II by 21 CFR § 888.3360
Product Code: 87 JDG
Owner/Operator # 9001269

3. Device Classification

Classification for ULTIMA* Unipolar Head and Adapter Sleeves has been placed in Class II by 21 CFR § 888.3360

4. Statement of Substantial Equivalence

The safety and effectiveness of the ULTIMA* Unipolar Head and Adapter Sleeves is substantially equivalent in terms of function to the Johnson & Johnson ULTIMA* Unipolar Modular Head and the Howmedica Unitrax Unipolar System. Furthermore, analysis results demonstrate that the ULTIMA* Unipolar Head and Adapter Sleeves meets the set criteria for the establishment of “substantial equivalence”.

5. Indications for Use

The ULTIMA* Unipolar Head is indicated for use in conjunction with a modular femoral stem in partial hip replacement procedures for patients suffering severe pain and disability due to:

1. femoral neck fracture,
2. avascular necrosis of the femoral head,
3. osteoarthritis,
4. abnormalities where:
- the major pathology affects the femoral head,
- the acetabular cavity is normal and not deformed or weakened,
- acetabular replacement is not required or desirable.

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# 6. Physical Description

The ULTIMA* Unipolar Head is provided in a size range of 38mm to 63mm (outer diameter), in 1mm increments. Sizes from 44mm through 63mm are manufactured as a two-piece assembly. The two pieces are made of cast cobalt-chromium-molybdenum alloy conforming to ASTM F75. Both pieces are treated with hot isostatic pressing and solution annealing. The two cast pieces are machined and then joined permanently by electron beam welding to form a hollow unipolar head. Sizes from 38mm through 43mm are cast from cobalt-chromium-molybdenum alloy as a solid head, and are isostatic pressed and solution annealed before machining. Both of these size ranges are finish machined to the outer diameter size. The outer diameter is highly polished for articulation with the implant recipient's natural acetabulum.

The ULTIMA* Unipolar Head has a tapered bore which can receive a variety of Adapter Sleeves. The adapter sleeves can be tapered on the outside to the mate with the unipolar head, and tapered on the inside to mate with the appropriate femoral stem trunnion. The adapter sleeves are available in a 10/12 taper, in size increments for -3mm, +0mm, +5mm. and +10mm neck lengths; in a 11/13 taper, in size increments for +0mm, +6mm, and +12mm neck lengths; and in a 12/14 taper, in size increments for +0mm, +3.5mm, and +7mm neck lengths. The adapter sleeves are machined from cobalt-chromium-molybdenum alloy in wrought bar form conforming ASTM F799.

Table 1. Similarities and Differences Matrix

| | ULTIMA* Unipolar Head and Adapter Sleeves | ULTIMA* Unipolar Modular Head | Howmedica Unitrax Unipolar System |
| --- | --- | --- | --- |
| | | | |
| DESIGN | | | |
| Range of sizes | 38mm-63mm
(1mm increments) | 38mm-65mm
(1mm increments) | 38mm-63mm
(1mm increments) |
| Adapter sleeve for increased neck length | Yes | No | Yes |
| Number neck length sizes | 10/12 taper: -3mm, +0mm, +5mm, +10mm
11/13 taper: +0mm, +6mm, +12mm
12/14 taper: +0mm, +3.5mm, +7mm | +0mm, +5mm | -4mm, +0mm, +5mm, +10mm |
| Morse-taper locking mechanism to modular femoral stem | Yes | Yes | Yes |
| | | | |
| INTENDED USE | | | |
| Partial hip replacement | Yes | Yes | Yes |
| | | | |
| MATERIALS | | | |
| Manufactured from Co-Cr-Mo | Yes | Yes | Yes |