Cleared Special

K001957 - MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT

K001957 is an FDA 510(k) clearance for MODULAR ROTATING HINGE KNEE TIBIAL ROTA..., manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code KRO cleared through the Special 510(k) pathway after a 28-day FDA review.

K001957 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
28d
Days
Class 2
Risk

K001957 is an FDA 510(k) clearance for the MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Rutherford, US). The FDA issued a Cleared decision on July 25, 2000 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - 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 - K001957

510(k) Number K001957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2000
Decision Date July 25, 2000
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

KRO Device Classification - Class 2, Special Controls

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 86
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K001957.
RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
K003504 · Plus Orthopedics · May 2001
AVL HINGE KNEE SYSTEM
K010774 · Biomet, Inc. · Apr 2001
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K002552 · Howmedica Osteonics Corp. · Nov 2000
MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
K001548 · Howmedica Osteonics Corp. · Jun 2000
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K994207 · Howmedica Osteonics Corp. · Mar 2000
HINGED KNEE
K982160 · Encore Orthopedics, Inc. · Mar 1999
K001957 · MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT
Download PDF FDA Summary Howmedica Osteonics C…