Cleared Traditional

K003269 - UNICONDYLAR INTERPOSITIONAL SPACER

K003269 is an FDA 510(k) clearance for UNICONDYLAR INTERPOSITIONAL SPACER, manufactured by Sulzer Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code HSH cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K003269 · Sulzer Orthopedics, Inc. · Orthopedic device
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Jan 2001
Decision
78d
Days
Class 2
Risk

K003269 is an FDA 510(k) clearance for the UNICONDYLAR INTERPOSITIONAL SPACER. Classified as Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented) (product code HSH), Class II - Special Controls.

Submitted by Sulzer Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on January 4, 2001 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3590 - 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 Sulzer Orthopedics, Inc. devices

FDA 510(k) Submission Details - K003269

510(k) Number K003269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2000
Decision Date January 04, 2001
Days to Decision 78 days
Submission Type Traditional
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
44d faster than avg
Panel avg: 122d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSH Device Classification - Class 2, Special Controls

Product Code HSH Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3590
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.