Cleared Traditional

K061599 - PIN SCREW

K061599 is the FDA 510(k) clearance for PIN SCREW by Bk Meditech, Co., Ltd.. It is a Class 2 Orthopedic device (product code JDW) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K061599 · Bk Meditech, Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
48d
Days
Class 2
Risk

K061599 is an FDA 510(k) clearance for the PIN SCREW. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Bk Meditech, Co., Ltd. (Hwasung-Si, Kyunggi-Do, KR). The FDA issued a Cleared decision on July 26, 2006 after a review of 48 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 Bk Meditech, Co., Ltd. devices

Submission Details

510(k) Number K061599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2006
Decision Date July 26, 2006
Days to Decision 48 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
74d faster than avg
Panel avg: 122d · This submission: 48d
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 49
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K061599.
SMV Scientific K-Wire and Pins
K182171 · Summit Medventures · Oct 2018
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
K120871 · Smith & Nephew, Inc. · Jun 2012
ROCKWOOD CLAVICLE PINS
K103001 · DePuy Orthopaedics, Inc. · Feb 2011
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
JET-X HA COATED HALF PINS
K023921 · Smith & Nephew, Inc. · Feb 2003