Cleared Traditional

K011875 - MODIFICATION TO THE TAC' PIN

K011875 is the FDA 510(k) clearance for MODIFICATION TO THE TAC' PIN by New Deal, S.A.. It is a Class 2 Orthopedic device (product code JDW) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K011875 · New Deal, S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
83d
Days
Class 2
Risk

K011875 is an FDA 510(k) clearance for the MODIFICATION TO 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 September 6, 2001 after a review of 83 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

Submission Details

510(k) Number K011875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2001
Decision Date September 06, 2001
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 54
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K011875.
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
K021182 · Biomet, Inc. · May 2002
STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM
K020097 · Stryker Endoscopy · Mar 2002
STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM
K012270 · Stryker Endoscopy · Sep 2001
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
K011319 · Stryker Endoscopy · Jul 2001
RESORBABLE HAMMERTOE PIN
K011137 · Biomet, Inc. · Jun 2001
APEX FIXATION PINS
K011136 · Howmedica Osteonics Corp. · May 2001