Cleared Traditional

K001720 - SYNTHES SACRAL BAR SYSTEM

K001720 is the FDA 510(k) clearance for SYNTHES SACRAL BAR SYSTEM by Synthes (Usa). It is a Class 2 Orthopedic device (product code JDW) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K001720 · Synthes (Usa) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2000
Decision
79d
Days
Class 2
Risk

K001720 is an FDA 510(k) clearance for the SYNTHES SACRAL BAR SYSTEM. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on August 24, 2000 after a review of 79 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 Synthes (Usa) devices

Submission Details

510(k) Number K001720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2000
Decision Date August 24, 2000
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
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 52
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K001720.
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
K002605 · Synthes (Usa) · Nov 2000
BIOMET LATERAL TROCH PLATE
K003294 · Biomet, Inc. · Nov 2000
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT
K003131 · Biomet, Inc. · Nov 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
DEPUY ROCKWOOD CLAVICLE PIN
K991649 · Depuy, Inc. · Jul 1999