Cleared Special

K113303 - OSLEOBRIDGE IDSF SPACER CONECTOR

K113303 is an FDA 510(k) clearance for OSLEOBRIDGE IDSF SPACER CONECTOR, manufactured by Merete Medical GmbH. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 30-day FDA review.

K113303 · Merete Medical GmbH · Orthopedic device
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Dec 2011
Decision
30d
Days
Class 2
Risk

K113303 is an FDA 510(k) clearance for the OSLEOBRIDGE IDSF SPACER CONECTOR. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Merete Medical GmbH (Berlin, DE). The FDA issued a Cleared decision on December 9, 2011 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Merete Medical GmbH devices

FDA 510(k) Submission Details - K113303

510(k) Number K113303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2011
Decision Date December 09, 2011
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 365
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K113303.
OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR
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K111891 · Synthes USA Products, LLC · Nov 2011
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K111025 · Smith & Nephew, Inc. · Jul 2011