Cleared Traditional

K000682 - SYNTHES LARGE FRAGMENT DYNAMIC COMPRESS...

K000682 is the FDA 510(k) clearance for SYNTHES LARGE FRAGMENT DYNAMIC COMPRESS... by Synthes (Usa). It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K000682 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
62d
Days
Class 2
Risk

K000682 is an FDA 510(k) clearance for the SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on May 1, 2000 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 K000682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2000
Decision Date May 01, 2000
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 276
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K000682.
COLLES C SERIES FRAME STERILE PACK
K003397 · DePuy Orthopaedics, Inc. · Jan 2001
EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM
K001358 · Ebi, L.P. · May 2000
PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601
K000734 · Pioneer Surgical Technology · May 2000
SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
K000684 · Synthes (Usa) · Apr 2000
EBI XFIX DFS SYSTEM
K000319 · Ebi, L.P. · Feb 2000
EBI XFIX DFS RAIL SYSTEM
K000083 · Ebi, L.P. · Feb 2000