Cleared Traditional

K980637 - IMPLEX CONTINUUM KNEE UNITY TIBIAL COMP...

K980637 is the FDA 510(k) clearance for IMPLEX CONTINUUM KNEE UNITY TIBIAL COMP... by Implex Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K980637 · Implex Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
300d
Days
Class 2
Risk

K980637 is an FDA 510(k) clearance for the IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT. 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 December 16, 1998 after a review of 300 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: 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 K980637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1998
Decision Date December 16, 1998
Days to Decision 300 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
178d slower than avg
Panel avg: 122d · This submission: 300d
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 K980637.
CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENT
K984291 · Implex Corp. · Feb 1999
P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY
K984158 · Depuy, Inc. · Jan 1999
SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL BASEPLATE STEM PLUGS
K983733 · Sulzer Orthopedics, Inc. · Dec 1998
DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION
K980925 · Howmedica Corp. · Dec 1998
DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION
K980632 · Howmedica Corp. · Dec 1998
NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS
K983153 · Sulzer Orthopedics, Inc. · Dec 1998