Cleared Special

K992346 - KINEMATIC II ROTATING HINGE KNEE

K992346 is an FDA 510(k) clearance for KINEMATIC II ROTATING HINGE KNEE, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code LGE cleared through the Special 510(k) pathway after a 30-day FDA review.

K992346 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
30d
Days
Class 2
Risk

K992346 is an FDA 510(k) clearance for the KINEMATIC II ROTATING HINGE KNEE. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Trunnion-bearing (product code LGE), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on August 12, 1999 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K992346

510(k) Number K992346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1999
Decision Date August 12, 1999
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

LGE Device Classification - Class 2, Special Controls

Product Code LGE Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Trunnion-bearing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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.

K992346 · KINEMATIC II ROTATING HINGE KNEE
Download PDF FDA Summary Howmedica Osteonics C…