Cleared Traditional

K931655 - P.F.C. BIPOLAR HIP SYSTEM

K931655 is an FDA 510(k) clearance for P.F.C. BIPOLAR HIP SYSTEM, manufactured by Johnson & Johnson Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 430-day FDA review.

K931655 · Johnson & Johnson Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
430d
Days
Class 2
Risk

K931655 is an FDA 510(k) clearance for the P.F.C. BIPOLAR HIP SYSTEM. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Johnson & Johnson Orthopaedics, Inc. (Raynham, US). The FDA issued a Cleared decision on June 9, 1994 after a review of 430 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Johnson & Johnson Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K931655

510(k) Number K931655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1993
Decision Date June 09, 1994
Days to Decision 430 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
308d slower than avg
Panel avg: 122d · This submission: 430d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWY Device Classification - Class 2, Special Controls

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 85
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K931655.
MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM
K941534 · 3M Health Care, Ltd. · Mar 1995
P.F.C. TOTAL HIP SYSTEM
K944132 · Johnson & Johnson Professionals, Inc. · Jan 1995
IOI COCR UNIPOLAR PROSTHESIS
K934159 · Intermedics Orthopedics · Jul 1994
IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM
K925153 · Howmedica Corp. · Mar 1994
TECHMEDICA STANDARD CEMENTED HIP SYSTEM
K926387 · Techmedica, Inc. · Feb 1994
HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM
K925536 · Orthomet, Inc. · Jan 1994