Cleared Traditional

K071090 - TRABECULAR METAL GLENOID- B/F COMPLETE ...

K071090 is an FDA 510(k) clearance for TRABECULAR METAL GLENOID- B/F COMPLETE ..., manufactured by Zimmer Trabecular Metal Technology. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K071090 · Zimmer Trabecular Metal Technology · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
72d
Days
Class 2
Risk

K071090 is an FDA 510(k) clearance for the TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Zimmer Trabecular Metal Technology (Parsippany, US). The FDA issued a Cleared decision on June 29, 2007 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - 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 Zimmer Trabecular Metal Technology devices

FDA 510(k) Submission Details - K071090

510(k) Number K071090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2007
Decision Date June 29, 2007
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWS Device Classification - Class 2, Special Controls

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 166
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K071090.
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K071032 · Arthrex, Inc. · Aug 2007
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K062113 · Howmedica Osteonics Corp. · Oct 2006