Cleared Traditional

K983835 - IMPLEX CONTINUUM PATELLA-REVISION HEDRO...

K983835 is the FDA 510(k) clearance for IMPLEX CONTINUUM PATELLA-REVISION HEDRO... by Implex Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K983835 · Implex Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 1999
Decision
136d
Days
Class 2
Risk

K983835 is an FDA 510(k) clearance for the IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on March 15, 1999 after a review of 136 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 Implex Corp. devices

Submission Details

510(k) Number K983835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1998
Decision Date March 15, 1999
Days to Decision 136 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
14d slower than avg
Panel avg: 122d · This submission: 136d
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 764
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K983835.
ASCENT KNEE SYSTEM
K991428 · Biomet, Inc. · May 1999
OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INSERT
K991461 · Howmedica Osteonics Corp. · May 1999
GAS PLASMA STERILIZATION
K972774 · Zimmer, Inc. · May 1999
TITANIUM FEMORAL COMPONENT
K981996 · Biomet, Inc. · Mar 1999
MAXIM REMOVABLE MOLDED POLY TIBIA
K984623 · Biomet, Inc. · Mar 1999
ADVANCED REVISION PRODUCT LINE EXTENSION
K990030 · Wrightmedicaltechnologyinc · Feb 1999