Cleared Traditional

AMK TOTAL KNEE SYSTEM WITHOUT POROCOAT (K883122) - FDA 510(k) Clearance

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

K883122 · Depuy, Inc. · Orthopedic device
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Dec 1988
Decision
128d
Days
Class 2
Risk

K883122 is an FDA 510(k) clearance for the AMK TOTAL KNEE SYSTEM WITHOUT POROCOAT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 1, 1988 after a review of 128 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Depuy, Inc. devices

Submission Details

510(k) Number K883122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1988
Decision Date December 01, 1988
Days to Decision 128 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 122d · This submission: 128d
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 K883122.
P.F.C.(TM) MODULAR KNEE SYSTEM
K884796 · Johnson & Johnson Professionals, Inc. · Mar 1989
OMNIFIT TOTAL KNEE SERIES III,IV & POST. STAB. FEM
K884410 · Osteonics Corp. · Jan 1989
OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS
K884398 · Osteonics Corp. · Jan 1989
JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESIS
K882234 · Johnson & Johnson Professionals, Inc. · Oct 1988
PCA MODULAR TOTAL KNEE-UNIVERSAL TIBIAL BASEPLATE
K874923 · Howmedica Corp. · Oct 1988
PCA MODULAR TOTAL KNEE SYS-ALL PLAS PATELLAR COMP
K881982 · Howmedica Corp. · Jul 1988