Cleared Traditional

DORR KNEE SYSTEM (K901085) - FDA 510(k) Clearance

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

K901085 · Intermedics Orthopedics · Orthopedic device
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Sep 1990
Decision
194d
Days
Class 2
Risk

K901085 is an FDA 510(k) clearance for the DORR KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on September 19, 1990 after a review of 194 days - an extended review cycle.

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 Intermedics Orthopedics devices

Submission Details

510(k) Number K901085 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 09, 1990
Decision Date September 19, 1990
Days to Decision 194 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 122d · This submission: 194d
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 522
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K901085.
KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEM
K904208 · Howmedica Corp. · Apr 1991
AMK MODULAR TIBIAL WEDGE SYSTEM
K904205 · Depuy, Inc. · Oct 1990
PCA (R) TIBIAL BONE WEDGES
K904170 · Howmedica Corp. · Oct 1990
AMK UNIVERSAL FEMORAL COMPONENT
K902246 · Depuy, Inc. · Aug 1990
ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED
K901406 · Depuy, Inc. · Jul 1990
MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR
K895639 · Zimmer, Inc. · Feb 1990