Cleared Special

K010121 - STERILE BUTTON PLATE

K010121 is the FDA 510(k) clearance for STERILE BUTTON PLATE by Synthes (Usa). It is a Class 2 Orthopedic device (product code MBI) cleared through the Special 510(k) pathway after a 24-day FDA review.

K010121 · Synthes (Usa) · Orthopedic device
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Feb 2001
Decision
24d
Days
Class 2
Risk

K010121 is an FDA 510(k) clearance for the STERILE 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 February 9, 2001 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Synthes (Usa) devices

Submission Details

510(k) Number K010121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2001
Decision Date February 09, 2001
Days to Decision 24 days
Submission Type Special
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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 K010121.
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K011007 · Arthrex, Inc. · Jun 2001
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K010457 · Arthrex, Inc. · May 2001
SYNTHES BUTTON PLATE
K994364 · Synthes (Usa) · Mar 2000
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K000279 · American Medical Systems, Inc. · Mar 2000
ACUMED SUTURE ANCHOR
K993657 · Acu Med, Inc. · Jan 2000