Cleared Special

K121220 - EQUINOXE GLENOID

K121220 is the FDA 510(k) clearance for EQUINOXE GLENOID by Exactech, Inc.. It is a Class 2 Orthopedic device (product code KWS) cleared through the Special 510(k) pathway after a 211-day FDA review.

K121220 · Exactech, Inc. · Orthopedic device
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Nov 2012
Decision
211d
Days
Class 2
Risk

K121220 is an FDA 510(k) clearance for the EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on November 20, 2012 after a review of 211 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Exactech, Inc. devices

Submission Details

510(k) Number K121220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2012
Decision Date November 20, 2012
Days to Decision 211 days
Submission Type Special
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
89d slower than avg
Panel avg: 122d · This submission: 211d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 153
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K121220.
LIMACORPORATE SMR CTA HUMERAL HEADS
K131112 · Lima Corporate S.P.A. · Jun 2013
UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM
K130129 · Arthrex, Inc. · May 2013
TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+
K123982 · Encore Medical, L.P. · Jan 2013
ASCEND SHOULDER SYSTEM
K121493 · Tornier, Inc. · Jun 2012
ASCEND SHOULDER SYSTEM
K120794 · Tornier, Inc. · Apr 2012
ASCEND SHOULDER SYSTEM
K113413 · Tornier, Inc. · Mar 2012