Cleared Traditional

ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY (K112885) - FDA 510(k) Clearance

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

K112885 · Zimmer, Inc. · Orthopedic device
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Dec 2011
Decision
80d
Days
Class 2
Risk

K112885 is an FDA 510(k) clearance for the ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 19, 2011 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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, Inc. devices

Submission Details

510(k) Number K112885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date December 19, 2011
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 401
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K112885.
MEDLINE CANNULATED SCREW
K130319 · Medline Industries, Inc. · May 2013
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
K122596 · Smith & Nephew, Inc. · Nov 2012
PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION
K120645 · Wrightmedicaltechnologyinc · Apr 2012
SI-LOK SACROILIAC JOINT FIXATION SYSTEM
K112028 · Globus Medical, Inc. · Dec 2011
SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
K111994 · Smith & Nephew, Inc. · Oct 2011
ORTHOLOC(TM) BONE SCREWS
K112772 · Wrightmedicaltechnologyinc · Oct 2011