Cleared Traditional

K994364 - SYNTHES BUTTON PLATE

K994364 is the FDA 510(k) clearance for SYNTHES BUTTON PLATE by Synthes (Usa). It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K994364 · Synthes (Usa) · Orthopedic device
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Mar 2000
Decision
79d
Days
Class 2
Risk

K994364 is an FDA 510(k) clearance for the SYNTHES BUTTON PLATE. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on March 15, 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 K994364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1999
Decision Date March 15, 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 MBI Fastener, Fixation, Nondegradable, Soft Tissue
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 390
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K994364.
TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55
K011007 · Arthrex, Inc. · Jun 2001
ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924
K010457 · Arthrex, Inc. · May 2001
STERILE BUTTON PLATE
K010121 · Synthes (Usa) · Feb 2001
STAPLETAC2 BONE ANCHOR SYSTEM
K000279 · American Medical Systems, Inc. · Mar 2000
ACUMED SUTURE ANCHOR
K993657 · Acu Med, Inc. · Jan 2000
BONE ANCHOR SYSTEM III (BAS III)
K990295 · Boston Scientific Corp · Mar 1999