Cleared Traditional

ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT (K921182) - FDA 510(k) Clearance

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

K921182 · Biomet, Inc. · Orthopedic device
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Jul 1993
Decision
500d
Days
Class 2
Risk

K921182 is an FDA 510(k) clearance for the ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 23, 1993 after a review of 500 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 Biomet, Inc. devices

Submission Details

510(k) Number K921182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1992
Decision Date July 23, 1993
Days to Decision 500 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
378d slower than avg
Panel avg: 122d · This submission: 500d
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 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K921182.
AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY
K925837 · Depuy, Inc. · Jan 1994
MG II POROUS KNEE SYSTEM FEMORAL COMPONENTS
K930831 · Zimmer, Inc. · Nov 1993
ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED
K933304 · Depuy, Inc. · Aug 1993
KINEMAX(R) CONDYLAR TOTAL KNEE SYST FEMORAL SPACER
K925901 · Howmedica Corp. · Mar 1993
DURACON METAL BACKED PATELLA
K923573 · Howmedica Corp. · Mar 1993
OSTEONICS(R) 700 SERIES TOTAL KNEE MOD FEMOR COMP
K925372 · Osteonics Corp. · Feb 1993