Cleared Special

K022437 - UNI KNEE

K022437 is an FDA 510(k) clearance for UNI KNEE, manufactured by Encore Medical, L.P.. The device is a Class 2 Orthopedic device with product code HRY cleared through the Special 510(k) pathway after a 29-day FDA review.

K022437 · Encore Medical, L.P. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2002
Decision
29d
Days
Class 2
Risk

K022437 is an FDA 510(k) clearance for the UNI KNEE. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on August 23, 2002 after a review of 29 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.

View all Encore Medical, L.P. devices

FDA 510(k) Submission Details - K022437

510(k) Number K022437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2002
Decision Date August 23, 2002
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

HRY Device Classification - Class 2, Special Controls

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
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.

Regulatory Peers - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 75
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K022437.
UC-PLUS SOLUTION UNICONDYLAR KNEE
K032052 · Plus Orthopedics · Jul 2003
REPICCI LOCKED KEEL TIBIAL BEARING
K030446 · Biomet, Inc. · Mar 2003
ADVANCE LESS CONFORMING TIBIAL COMPONENT
K030193 · Wrightmedicaltechnologyinc · Feb 2003
FIXED BEARING UNI COMPONENT
K021621 · Biomet, Inc. · Jun 2002
UNICONDYLAR KNEE
K020741 · Encore Orthopedics, Inc. · Jun 2002
ADVANCE UNICONDYLAR KNEE SYSTEM
K014171 · Wrightmedicaltechnologyinc · Mar 2002