Cleared Traditional

K062113 - SOLAR REUNION FRACTURE STEM

K062113 is an FDA 510(k) clearance for SOLAR REUNION FRACTURE STEM, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K062113 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
71d
Days
Class 2
Risk

K062113 is an FDA 510(k) clearance for the SOLAR REUNION FRACTURE STEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on October 3, 2006 after a review of 71 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 Howmedica Osteonics Corp. devices

FDA 510(k) Submission Details - K062113

510(k) Number K062113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2006
Decision Date October 03, 2006
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
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 184
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K062113.
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K060874 · DePuy Orthopaedics, Inc. · Jun 2006
AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM
K060209 · Tornier · Mar 2006
DEPUY GLOBAL SHOULDER CROSSLINK GLENOID
K052472 · DePuy Orthopaedics, Inc. · Oct 2005