Cleared Traditional

K152841 - Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws

K152841 is an FDA 510(k) clearance for Zimmer Plates and Screws System (ZPS) S..., 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 56-day FDA review.

K152841 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
56d
Days
Class 2
Risk

K152841 is an FDA 510(k) clearance for the Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws. 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 November 24, 2015 after a review of 56 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 - K152841

510(k) Number K152841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2015
Decision Date November 24, 2015
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 951
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K152841.
Monster BITE Screw System
K153378 · Paragon 28 · Dec 2015
Tyber Medical MST Trauma Screw
K153180 · Tyber Medical, LLC · Nov 2015
SELF- COMPRESSIVE SCREW
K153182 · Neosteo · Nov 2015
EzFuze Implant System
K150211 · Vilex IN Tennessee, Inc. · Nov 2015
Integra DigiFuse Cannulated Intramedullary Fusion System
K152527 · Ascension Orthopedics · Oct 2015
HammerFiX Device
K152710 · Extremity Medical, LLC · Oct 2015