Cleared Traditional

REPLICA(TM) TOTAL HIP SYSTEM (K926156) - FDA 510(k) Clearance

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

K926156 · Osteo Technology, Inc. · Orthopedic device
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Mar 1994
Decision
457d
Days
Class 2
Risk

K926156 is an FDA 510(k) clearance for the REPLICA(TM) TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Osteo Technology, Inc. (Timonium, US). The FDA issued a Cleared decision on March 9, 1994 after a review of 457 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 Osteo Technology, Inc. devices

Submission Details

510(k) Number K926156 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 07, 1992
Decision Date March 09, 1994
Days to Decision 457 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
335d slower than avg
Panel avg: 122d · This submission: 457d
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 K926156.
TRILOGY ACETABULAR SYSTEM
K934765 · Zimmer, Inc. · Apr 1994
POROCOAT POROUS COATING/AML PROXIMALLY-COATED STEM
K933787 · Depuy, Inc. · Apr 1994
POROCOAT POROUS COATING
K931641 · Depuy, Inc. · Mar 1994
ACETABULAR SHELL
K935731 · Howmedica Corp. · Mar 1994
HG MULTILOCK HIP PROSTHESIS W/ TI-NIDIUM
K921308 · Zimmer, Inc. · Feb 1994
BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT
K921557 · Zimmer, Inc. · Feb 1994