Cleared Traditional

K922500 - PSL TOTAL HIP REPLACEMENT SYSTEM

K922500 is the FDA 510(k) clearance for PSL TOTAL HIP REPLACEMENT SYSTEM by Biopro, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 590-day FDA review.

K922500 · Biopro, Inc. · Orthopedic device
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Jan 1994
Decision
590d
Days
Class 2
Risk

K922500 is an FDA 510(k) clearance for the PSL TOTAL HIP REPLACEMENT SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on January 7, 1994 after a review of 590 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Biopro, Inc. devices

Submission Details

510(k) Number K922500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1992
Decision Date January 07, 1994
Days to Decision 590 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
468d slower than avg
Panel avg: 122d · This submission: 590d
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 446
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K922500.
PMI HIP FEMORAL
K923452 · Biomet, Inc. · Feb 1994
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K921274 · Biomet, Inc. · Feb 1994
APR(R) HIP SYST & NATURAL-HIP(R) FOR UNCEMENT USE
K920955 · Intermedics Orthopedics · Feb 1994
EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM
K921113 · Exactech, Inc. · Oct 1993
EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR
K921114 · Exactech, Inc. · Oct 1993
INFINITY POROUS-COATED TROCHANTERIC MODULE
K922159 · Wrightmedicaltechnologyinc · Oct 1993