Cleared Traditional

K053513 - T-PIN

K053513 is an FDA 510(k) clearance for T-PIN, manufactured by Union Surgical, LLC. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K053513 · Union Surgical, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
28d
Days
Class 2
Risk

K053513 is an FDA 510(k) clearance for the T-PIN. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Union Surgical, LLC (Philadelphia, US). The FDA issued a Cleared decision on January 13, 2006 after a review of 28 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 Union Surgical, LLC devices

FDA 510(k) Submission Details - K053513

510(k) Number K053513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2005
Decision Date January 13, 2006
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 78
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K053513.
NEXFIX COMPRESSION PIN
K072710 · Nexa Orthopedics, Inc. · Nov 2007
SBI TITANIUM THREADED PIN
K071540 · Small Bone Innovations, Inc. · Aug 2007
ALLOFIX ANCHOR, 5.0 MM ANCHOR
K061498 · Musculoskeletal Transplant Foundation · Jul 2006
TAPERED COMPRESSION PIN
K051740 · Nexa Orthopedics, Inc. · Sep 2005
SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS
K040765 · Synthes (Usa) · Apr 2004
MODIFICATION TO JET-X HA COATED HALF PINS
K033289 · Smith & Nephew, Inc. · Jan 2004