Cleared Special

K070236 - SBI LATERAL RADIO CAPITELLUM

K070236 is an FDA 510(k) clearance for SBI LATERAL RADIO CAPITELLUM, manufactured by Small Bone Innovations, Inc.. The device is a Class 2 Orthopedic device with product code JDB cleared through the Special 510(k) pathway after a 27-day FDA review.

K070236 · Small Bone Innovations, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
27d
Days
Class 2
Risk

K070236 is an FDA 510(k) clearance for the SBI LATERAL RADIO CAPITELLUM. Classified as Prosthesis, Elbow, Semi-constrained, Cemented (product code JDB), Class II - Special Controls.

Submitted by Small Bone Innovations, Inc. (Newyork, US). The FDA issued a Cleared decision on February 21, 2007 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3160 - 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.

FDA 510(k) Submission Details - K070236

510(k) Number K070236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2007
Decision Date February 21, 2007
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

JDB Device Classification - Class 2, Special Controls

Product Code JDB Prosthesis, Elbow, Semi-constrained, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3160
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 - JDB Prosthesis, Elbow, Semi-constrained, Cemented

All 25
Devices cleared under the same product code (JDB) and FDA review panel - the closest regulatory comparables to K070236.
RHEAD RADIAL HEAD EXTENDED STEMS
K102180 · Small Bone Innovations, Inc. · Dec 2010
LATITUDE ELBOW PROSTHESIS
K100562 · Tornier, Inc. · Jun 2010
LATITUDE ELBOW PROTHESIS
K070787 · Tornier · Aug 2007
RHS
K060438 · Tornier · Apr 2006
SBI RADIO-CAPITELLAR IMPLANT
K060038 · Small Bone Innovations, Inc. · Mar 2006
TORNIER ELBOW PROSTHESIS
K050848 · Tornier · Jul 2005