Cleared Traditional

K861266 - HOWMEDICA KINEMATIC PLUS KNEE SYSTEM

K861266 is an FDA 510(k) clearance for HOWMEDICA KINEMATIC PLUS KNEE SYSTEM, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K861266 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1986
Decision
111d
Days
Class 2
Risk

K861266 is an FDA 510(k) clearance for the HOWMEDICA KINEMATIC PLUS KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on July 24, 1986 after a review of 111 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K861266

510(k) Number K861266 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 04, 1986
Decision Date July 24, 1986
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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 885
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K861266.
OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM
K863668 · Osteonics Corp. · Dec 1986
MODIFIED SYNATOMIC KNEE PATELLA PROSTHESIS
K863667 · Depuy, Inc. · Dec 1986
MILLER/GALANTE TOTAL KNEE POR COATED PATELLAR DOME
K863805 · Zimmer, Inc. · Dec 1986
SYNATOMIC REVISION FEMORAL PROSTHESIS
K860594 · Depuy, Inc. · Mar 1986
M.C.R. KNEE PROSTHESIS (SERIES 3000)
K860654 · Osteonics Corp. · Mar 1986
HOFMANN KNEE
K853991 · Intermedics Orthopedics · Feb 1986