Cleared Traditional

K051098 - PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES

K051098 is an FDA 510(k) clearance for PERIARTICULAR LOCKING PLATES AND SCREWS, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K051098 · Zimmer, Inc. · Orthopedic device
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Jul 2005
Decision
69d
Days
Class 2
Risk

K051098 is an FDA 510(k) clearance for the PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES. 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 July 7, 2005 after a review of 69 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

FDA 510(k) Submission Details - K051098

510(k) Number K051098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2005
Decision Date July 07, 2005
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

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 974
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K051098.
MATRYX INTERFERENCE SCREW
K052080 · Linvatec Biomaterials, Inc. · Aug 2005
PLC SCREW
K051310 · Smith & Nephew, Inc. · Jul 2005
ROI FUSION RODS & PLATES
K051309 · Reiley Orthopaedics, Inc. · Jul 2005
MERETE TWISTCUT SNAP-OFF BONE SCREW
K051323 · Merete Medical GmbH · Jul 2005
ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM
K043176 · Arc Surgical, LLC · Jun 2005
STERLING INTERFERENCE SCREW ST
K050767 · Regeneration Technologies, Inc. · Jun 2005