Cleared Traditional

PCA TOTAL HIP SYSTEM (CEMENTLESS USE) (K920831) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K920831 · Pfizer Hospital Products Group, Inc. · Orthopedic device
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Jun 1992
Decision
111d
Days
Class 2
Risk

K920831 is an FDA 510(k) clearance for the PCA TOTAL HIP SYSTEM (CEMENTLESS USE). Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Pfizer Hospital Products Group, Inc. (Rutherford, US). The FDA issued a Cleared decision on June 10, 1992 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Pfizer Hospital Products Group, Inc. devices

Submission Details

510(k) Number K920831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1992
Decision Date June 10, 1992
Days to Decision 111 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K920831.
ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS
K926107 · Biomet, Inc. · Jul 1993
OSTEONICS MICROSUTERED FEMORAL COMPONENTES
K926201 · Osteonics Corp. · Jun 1993
BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM
K921639 · Zimmer, Inc. · Jul 1992
TRI-LOCK II TITANIUM ACETABULUM PROSTHESIS
K862702 · Depuy, Inc. · Jul 1986
POROUS COATED HIP FEMORAL PROSTHESIS
K862326 · Johnson & Johnson Professionals, Inc. · Jul 1986
PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259
K860442 · Howmedica Corp. · May 1986