Cleared Traditional

K883122 - AMK TOTAL KNEE SYSTEM WITHOUT POROCOAT

K883122 is an FDA 510(k) clearance for AMK TOTAL KNEE SYSTEM WITHOUT POROCOAT, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 128-day FDA review.

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

FDA 510(k) Submission Details - K883122

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.

JWH Device Classification - Class 2, Special Controls

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 891
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K883122.
LACEY POSTERIOR STABILIZED KNEE SYSTEM
K884338 · Dow Corning Wright · Feb 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
KIRSCHNER TC-IV/NON POR COAT/TOTAL CONDYLAR KNEE S
K883215 · Kirschner Medical Corp. · Nov 1988
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