P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT

K945518 · Johnson & Johnson Professionals, Inc. · KWY · Mar 8, 1996 · Orthopedic

Device Facts

• Record ID: K945518
• Device Name: P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT
• Applicant: Johnson & Johnson Professionals, Inc.
• Product Code: KWY · Orthopedic
• Decision Date: Mar 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component is indicated for use in total and 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. Use of a prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion. The P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component is indicated for use without bone cement (PMMA).

Device Story

P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component; modular femoral prosthesis for total/partial hip replacement. Device implanted by orthopedic surgeons in clinical settings. Provides structural replacement for damaged hip joints; facilitates joint function restoration. Smaller sizes added to existing product line to address proximal-to-distal anatomical incongruity. Used without bone cement (cementless fixation).

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material identity to previously cleared predicate device.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V). Modular femoral component design. Cementless fixation. Five additional sizes (1/1, 2/2, 3/3, 2/1, 3/2) added to existing range.

Indications for Use

Indicated for patients with severe hip pain/disability due to rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, femoral fracture non-union, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, or previous fusion. For use without bone cement.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.

Predicate Devices

• P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component (K935452)

Submission Summary (Full Text)

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K945578

EXHIBIT I

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component - Smaller Sizes

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

1. CONTACT PERSON

J. Teresa Dorriety, Esq., Sr. Regulatory Affairs Specialist, [phone]

2. NAME OF DEVICE

Proprietary Name: P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component
Common Name: Porous Coated Modular Femoral Prosthesis
Classification Name: Hip Joint Metal/Polymer Semi-Constrained

3. DEVICE CLASSIFICATION

Classification for porous coated modular femoral prosthesis has been placed in Class II by FDA (58 FR 3227, January 9, 1993).

4. STATEMENT OF SUBSTANTIAL EQUIVALENCE

The P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component in the smaller sizes is substantially equivalent and identical in function to the P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component cleared for commercial distribution under premarket notification #K935452.

5. INDICATIONS FOR USE

The P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component is indicated for use in total and 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. Use of a prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.

The P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component is indicated for use without bone cement (PMMA).

6. PHYSICAL DESCRIPTION

The P.F.C. 2 Total hip System Porous Coated Femoral Component in the smaller sizes is manufactured from titanium alloy (Ti-6Al-4V), the same material used to manufacture the P.F.C. 2 femoral components in the larger sizes. In addition to the sixteen sizes available under premarket notification #K935452, five additional sizes are available; three standard sizes (1/1, 2/2, and 3/3) and two additional sizes (2/1 and 3/2) to accommodate patient populations with proximal to distal incongruity.