Cleared Traditional

K993910 - TAC' PIN

K993910 is an FDA 510(k) clearance for TAC' PIN, manufactured by New Deal, S.A.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K993910 · New Deal, S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
76d
Days
Class 2
Risk

K993910 is an FDA 510(k) clearance for the TAC' PIN. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by New Deal, S.A. (Potomac, US). The FDA issued a Cleared decision on February 1, 2000 after a review of 76 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 New Deal, S.A. devices

FDA 510(k) Submission Details - K993910

510(k) Number K993910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1999
Decision Date February 01, 2000
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDW Device Classification - Class 2, Special Controls

Product Code JDW Pin, Fixation, Threaded
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 - JDW Pin, Fixation, Threaded

All 84
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K993910.
SYNTHES SACRAL BAR SYSTEM
K001720 · Synthes (Usa) · Aug 2000
APEX FIXATION PINS
K001886 · Howmedica Osteonics Corp. · Jul 2000
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]
K994143 · Smith & Nephew, Inc. · Feb 2000
DIGIT WIDGET
K992970 · Hand Biomechanics Lab, Inc. · Nov 1999
DEPUY ROCKWOOD CLAVICLE PIN
K991649 · Depuy, Inc. · Jul 1999
STAINLESS STEEL FIXATION PINS
K990353 · Bregma International Trading Company , Ltd. · Jun 1999