Cleared Traditional

K062898 - SBI LATERAL RHEAD IMPLANT

K062898 is an FDA 510(k) clearance for SBI LATERAL RHEAD IMPLANT, manufactured by Small Bone Innovations, Inc.. The device is a Class 2 Orthopedic device with product code KWI cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K062898 · Small Bone Innovations, Inc. · Orthopedic device
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Nov 2006
Decision
47d
Days
Class 2
Risk

K062898 is an FDA 510(k) clearance for the SBI LATERAL RHEAD IMPLANT. Classified as Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI), Class II - Special Controls.

Submitted by Small Bone Innovations, Inc. (New York, US). The FDA issued a Cleared decision on November 13, 2006 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3170 - 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 Small Bone Innovations, Inc. devices

FDA 510(k) Submission Details - K062898

510(k) Number K062898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2006
Decision Date November 13, 2006
Days to Decision 47 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
75d faster than avg
Panel avg: 122d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWI Device Classification - Class 2, Special Controls

Product Code KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3170
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 - KWI Prosthesis, Elbow, Hemi-, Radial, Polymer

All 23
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K062898.
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ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC
K131845 · Acumed, LLC · Sep 2013
EVOLVE MODULAR RADIAL HEAD
K060731 · Wrightmedicaltechnologyinc · Apr 2006
EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE
K051385 · Biomet, Inc. · Aug 2005
ACUMED ANATOMIC RADIAL HEAD SYSTEM
K041858 · Acumed, LLC · Oct 2004