Cleared Traditional

HOFMANN KNEE (K853991) - FDA 510(k) Clearance

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

K853991 · Intermedics Orthopedics · Orthopedic device
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Feb 1986
Decision
147d
Days
Class 2
Risk

K853991 is an FDA 510(k) clearance for the HOFMANN KNEE. 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 February 21, 1986 after a review of 147 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 Intermedics Orthopedics devices

Submission Details

510(k) Number K853991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1985
Decision Date February 21, 1986
Days to Decision 147 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 122d · This submission: 147d
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 K853991.
HOWMEDICA KINEMATIC PLUS KNEE SYSTEM
K861266 · Howmedica Corp. · Jul 1986
SYNATOMIC REVISION FEMORAL PROSTHESIS
K860594 · Depuy, Inc. · Mar 1986
M.C.R. KNEE PROSTHESIS (SERIES 3000)
K860654 · Osteonics Corp. · Mar 1986
MILLAR/GALANTE PRECOATED TOTAL KNEE
K853661 · Zimmer, Inc. · Dec 1985
THE P.C.A. DOME PATELLA COMPONENT
K852059 · Howmedica Corp. · Jul 1985
POROUS COATED TITANIUM KNEE PROSTHES-
K843907 · Johnson & Johnson Professionals, Inc. · Jan 1985