Cleared Special

K000232 - ROTAGLIDE + MODULAR KNEE SYSTEM WITH FI...

K000232 is an FDA 510(k) clearance for ROTAGLIDE + MODULAR KNEE SYSTEM WITH FI..., manufactured by Corin USA. The device is a Class 2 Orthopedic device with product code JWH cleared through the Special 510(k) pathway after a 29-day FDA review.

K000232 · Corin USA · Orthopedic device
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Feb 2000
Decision
29d
Days
Class 2
Risk

K000232 is an FDA 510(k) clearance for the ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on February 25, 2000 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 Corin USA devices

FDA 510(k) Submission Details - K000232

510(k) Number K000232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2000
Decision Date February 25, 2000
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Statement
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.

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 810
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K000232.
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