Cleared Traditional

K922841 - BIOPRO MODULAR TIBIAL TRAY

K922841 is the FDA 510(k) clearance for BIOPRO MODULAR TIBIAL TRAY by Biopro, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 466-day FDA review.

K922841 · Biopro, Inc. · Orthopedic device
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Sep 1993
Decision
466d
Days
Class 2
Risk

K922841 is an FDA 510(k) clearance for the BIOPRO MODULAR TIBIAL TRAY. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on September 21, 1993 after a review of 466 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 K922841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1992
Decision Date September 21, 1993
Days to Decision 466 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
344d slower than avg
Panel avg: 122d · This submission: 466d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 781
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K922841.
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THE NATURAL-KNEE REVISION
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ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED
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K925900 · Dow Corning Wright · Aug 1993