Cleared Traditional

K961900 - TIBIAL TRAY PLUG

K961900 is the FDA 510(k) clearance for TIBIAL TRAY PLUG by Wrightmedicaltechnologyinc. It is a Class 2 Orthopedic device (product code HRY) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K961900 · Wrightmedicaltechnologyinc · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 1996
Decision
70d
Days
Class 2
Risk

K961900 is an FDA 510(k) clearance for the TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on July 25, 1996 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K961900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1996
Decision Date July 25, 1996
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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 - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 75
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K961900.
OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS
K974434 · Osteonics Corp. · Jan 1998
REPICCI II UNICONDYLAR KNEE
K971938 · Biomet, Inc. · Aug 1997
P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM
K954481 · Johnson & Johnson Professionals, Inc. · Oct 1996
ADVANCE TIBIAL COMPONENT
K960617 · Wrightmedicaltechnologyinc · May 1996
NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM
K955778 · Intermedics Orthopedics · Mar 1996
GAS PLASMA STERILIZATION
K944538 · Depuy, Inc. · Sep 1995