P.F.C. CERAMIC HIP HEAD

K962248 · Johnson & Johnson Professionals, Inc. · LZO · Aug 29, 1996 · Orthopedic

Device Facts

• Record ID: K962248
• Device Name: P.F.C. CERAMIC HIP HEAD
• Applicant: Johnson & Johnson Professionals, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Aug 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hip Stem components are indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis and non-union of femoral fractures. These devices are indicated for use only with Bone Cement (PMMA). The P.F.C. Ceramic Hip Head is designed as a modular head, compatible with Johnson & Johnson Professional, Inc.'s femoral stems with a 12/14 Morse-type taper.

Device Story

Modular hip system consisting of P.F.C. Ceramic Hip Head and cemented femoral stems (P.F.C. Cemented, Ultima Cemented, Ultima Cemented Long). Ceramic head (Yttrium Stabilized Zirconium Oxide) mates with Co-Cr-Mo alloy femoral stem via 12/14 Morse-type taper. Intended for use with PMMA bone cement in total/partial hip arthroplasty. Used by orthopedic surgeons in clinical/OR settings to restore joint function and alleviate pain in patients with degenerative or traumatic hip conditions.

Clinical Evidence

Bench testing only; results exceed requirements of FDA Guidance Document for Ceramic Ball Hip Systems (Draft, Jan 10, 1995).

Technological Characteristics

Femoral stems: Cobalt-chromium-molybdenum alloy (ASTM F799). Ceramic Hip Head: Yttrium Stabilized Zirconium Oxide (PROZYR). Modular design with 12/14 Morse-type taper interface. Intended for cemented fixation (PMMA).

Indications for Use

Indicated for patients with severe hip pain/disability due to structural damage from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, or non-union of femoral fractures requiring total or partial hip replacement.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• P.F.C. Ceramic Hip Head (K933275)

Submission Summary (Full Text)

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AUG 29 1996

K962248

# EXHIBIT III

# SUMMARY OF SAFETY AND EFFECTIVENESS DATA

P.F.C. Ceramic Hip Head indicated for use with the P.F.C. Cemented Hip Stem, Ultima Cemented Hip Stem and Ultima Cemented Long Stem

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

1. Contact Person

Anne M. Griffin, Regulatory Affairs Specialist, (508) 828 - 3107.

2. Name of Device

P.F.C. Ceramic Hip Head indicated for use with the P.F.C. Cemented Hip Stem, Ultima Cemented Hip Stem and Ultima Cemented Long Stem. The P.F.C. Ceramic Hip Head has been cleared under 510(k) K933275.

3. Device Classification

Ceramic Hip Heads have been placed into Class II by 21 CFR 888.3353.

4. Statement of Substantial Equivalence

The Ceramic Hip Heads and the Cemented Hip Stems are identical in design, materials and indications for use to those already cleared for domestic commercial distribution. This Premarket Notification is for the labeling of the Hip Stems for use with the Ceramic Hip Head. The mating of the Co-Cr-Mo alloy trunnion of the Hip Stems does not alter the safety and effectiveness of the devices. The test results obtained for the Ceramic Hip Head exceed the requirements of the Guidance Document ("Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems"-Draft, January 10, 1995).

5. Indications for Use

The Hip Stem components are indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis and non-union of femoral fractures. These devices are indicated for use only with Bone Cement (PMMA).

The P.F.C. Ceramic Hip Head is designed as a modular head, compatible with Johnson & Johnson Professional, Inc.'s femoral stems with a 12/14 Morse-type taper.

6. Physical Description

All Hip Stem components are manufactured using cobalt-chromium-molybdenum alloy that complies with ASTM F799. The Ceramic Hip Head is manufactured of Yttrium Stabilized Zirconium Oxide (Zirconia), also known as PROZYR®.

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