Cleared Traditional

K884338 - LACEY POSTERIOR STABILIZED KNEE SYSTEM

K884338 is an FDA 510(k) clearance for LACEY POSTERIOR STABILIZED KNEE SYSTEM, manufactured by Dow Corning Wright. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K884338 · Dow Corning Wright · Orthopedic device
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Feb 1989
Decision
110d
Days
Class 2
Risk

K884338 is an FDA 510(k) clearance for the LACEY POSTERIOR STABILIZED KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on February 1, 1989 after a review of 110 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 Dow Corning Wright devices

FDA 510(k) Submission Details - K884338

510(k) Number K884338 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 14, 1988
Decision Date February 01, 1989
Days to Decision 110 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
12d faster than avg
Panel avg: 122d · This submission: 110d
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 787
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K884338.
POROUS COATED GENESIS FEMORAL COMPONENT
K885036 · Richards Medical Co., Inc. · Apr 1989
P.F.C.(TM) MODULAR KNEE SYSTEM
K884796 · Johnson & Johnson Professionals, Inc. · Mar 1989
CONTINUUM KNEE SYSTEM (CKS)
K882322 · Buckman Co., Inc. · 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
AMK TOTAL KNEE SYSTEM WITHOUT POROCOAT
K883122 · Depuy, Inc. · Dec 1988