Cleared Traditional

K000684 - SMALL FRAGMENT DYNAMIC COMPRESSION LOCK...

K000684 is the FDA 510(k) clearance for SMALL FRAGMENT DYNAMIC COMPRESSION LOCK... by Synthes (Usa). It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K000684 · Synthes (Usa) · Orthopedic device
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Apr 2000
Decision
59d
Days
Class 2
Risk

K000684 is an FDA 510(k) clearance for the SMALL 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 April 28, 2000 after a review of 59 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 K000684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2000
Decision Date April 28, 2000
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
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 K000684.
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
SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
K000682 · Synthes (Usa) · May 2000
EBI XFIX DFS SYSTEM
K000319 · Ebi, L.P. · Feb 2000
EBI XFIX DFS RAIL SYSTEM
K000083 · Ebi, L.P. · Feb 2000
SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM
K993289 · Smith & Nephew, Inc. · Dec 1999