Cleared Traditional

CONTINUUM KNEE SYSTEM (CKS) (K882322) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K882322 · Buckman Co., Inc. · Orthopedic device
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Feb 1989
Decision
247d
Days
Class 2
Risk

K882322 is an FDA 510(k) clearance for the CONTINUUM KNEE SYSTEM (CKS). Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on February 8, 1989 after a review of 247 days - an extended review cycle.

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 Buckman Co., Inc. devices

Submission Details

510(k) Number K882322 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 06, 1988
Decision Date February 08, 1989
Days to Decision 247 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 122d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 522
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K882322.
MG II POROUS TOTAL KNEE SYSTEM
K892800 · Zimmer, Inc. · Aug 1989
P.F.C. MODULAR KNEE SYSTEM, TIBIAL TRAY-POROUS
K892394 · Johnson & Johnson Professionals, Inc. · Jul 1989
P.F.C.(TM) MODULAR KNEE SYSTEM
K884796 · Johnson & Johnson Professionals, Inc. · Mar 1989
OMNIFIT TOTAL KNEE SERIES III,IV & POST. STAB. FEM
K884410 · Osteonics Corp. · Jan 1989
OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS
K884398 · Osteonics Corp. · Jan 1989
AMK TOTAL KNEE SYSTEM WITHOUT POROCOAT
K883122 · Depuy, Inc. · Dec 1988