Cleared Traditional

K121277 - Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE

K121277 is an FDA 510(k) clearance for Z-SNAP OFF SCREW, manufactured by Z-Medical GmbH & Co. KG. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K121277 · Z-Medical GmbH & Co. KG · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
194d
Days
Class 2
Risk

K121277 is an FDA 510(k) clearance for the Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Z-Medical GmbH & Co. KG (Tuttlingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on November 7, 2012 after a review of 194 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K121277

510(k) Number K121277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2012
Decision Date November 07, 2012
Days to Decision 194 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 122d · This submission: 194d
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 1042
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K121277.
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ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
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HAMMER TOE IMPLANT
K122959 · Trilliant Surgical, Ltd. · Nov 2012
NEXTRA TI HAMMERTOE CORRECTION SYSTEM
K122031 · Nextremity Solutions, LLC · Oct 2012