Cleared Traditional

K933935 - CKS POROUS COATED FEMORAL COMPONENT (FDA 510(k) Clearance)

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

K933935 · Techmedica, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
426d
Days
Class 2
Risk

K933935 is an FDA 510(k) clearance for the CKS POROUS COATED FEMORAL COMPONENT. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Techmedica, Inc. (Camarillo, US). The FDA issued a Cleared decision on October 11, 1994 after a review of 426 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Techmedica, Inc. devices

Submission Details

510(k) Number K933935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1993
Decision Date October 11, 1994
Days to Decision 426 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
304d slower than avg
Panel avg: 122d · This submission: 426d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.