Cleared Traditional

K212996 - Sterile PHALINX Hammertoe System

K212996 is the FDA 510(k) clearance for Sterile PHALINX Hammertoe System by Wrightmedicaltechnologyinc. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K212996 · Wrightmedicaltechnologyinc · Orthopedic device
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Nov 2021
Decision
57d
Days
Class 2
Risk

K212996 is an FDA 510(k) clearance for the Sterile PHALINX Hammertoe System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on November 16, 2021 after a review of 57 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K212996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2021
Decision Date November 16, 2021
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
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 556
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K212996.
OSSIOfiber Compression Screw, 3.5mm
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K202326 · Bespa Global, LLC · Nov 2021
Treace Medical Concepts (TMC) Screw Fixation System
K213036 · Treace Medical Concepts, Inc. · Oct 2021
ChM 4.5mm Cortical screws
K210490 · Chm Sp. Z O.O. · Oct 2021