Cleared Traditional

K901457 - CONTINUUM KNEE SYSTEM (CKS)

K901457 is an FDA 510(k) clearance for CONTINUUM KNEE SYSTEM (CKS), manufactured by Techmedica, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K901457 · Techmedica, Inc. · Orthopedic device
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Jun 1990
Decision
84d
Days
Class 2
Risk

K901457 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 Techmedica, Inc. (Camarillo, US). The FDA issued a Cleared decision on June 20, 1990 after a review of 84 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Techmedica, Inc. devices

FDA 510(k) Submission Details - K901457

510(k) Number K901457 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 28, 1990
Decision Date June 20, 1990
Days to Decision 84 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 800
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K901457.
SECOND GENERATION KNEE SYSTEM, FEMORAL, PATELLAR
K895145 · Orthomet, Inc. · Jul 1990
PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP
K901936 · Orthomet, Inc. · Jul 1990
WHITESIDE ORTHOLOC MODULAR POST. STAB. KNEE SYSTEM
K901992 · Dow Corning Wright · Jun 1990
KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM
K901338 · Kirschner Medical Corp. · May 1990
NUFFIELD TOTAL KNEE
K892503 · Orthopedic Systems, Inc. · May 1990
WHITESIDE ORTHOLOC MODULAR METAL-BACKED PATELLA
K896081 · Dow Corning Wright · Mar 1990