Cleared Traditional

SPACER-S TEMPORARY SHOULDER SPACER (K060535) - FDA 510(k) Clearance

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

K060535 · Tecres S.P.A. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2006
Decision
85d
Days
Class 2
Risk

K060535 is an FDA 510(k) clearance for the SPACER-S TEMPORARY SHOULDER SPACER. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Tecres S.P.A. (Gainesville, US). The FDA issued a Cleared decision on May 24, 2006 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3690 - 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 Tecres S.P.A. devices

Submission Details

510(k) Number K060535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2006
Decision Date May 24, 2006
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3690
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 - HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

All 33
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K060535.
MODULAR REPLACEMENT ELBOW SYSTEM
K062845 · Howmedica Osteonics Corp. · Dec 2006
SOLAR PUREFIX HA SHOULDER
K061677 · Howmedica Osteonics Corp. · Jul 2006
EXACTECH EQUINOXE SHOULDER STEMS
K061454 · Exactech, Inc. · Jun 2006
COPELAND EAS HUMERAL RESURFACING HEADS
K051843 · Biomet, Inc. · Sep 2005
MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS
K040128 · Howmedica Osteonics Corp. · Mar 2004
DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS
K033516 · DePuy Orthopaedics, Inc. · Dec 2003