Cleared Traditional

K060038 - SBI RADIO-CAPITELLAR IMPLANT

K060038 is an FDA 510(k) clearance for SBI RADIO-CAPITELLAR IMPLANT, manufactured by Small Bone Innovations, Inc.. The device is a Class 2 Orthopedic device with product code JDB cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K060038 · Small Bone Innovations, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
83d
Days
Class 2
Risk

K060038 is an FDA 510(k) clearance for the SBI RADIO-CAPITELLAR IMPLANT. Classified as Prosthesis, Elbow, Semi-constrained, Cemented (product code JDB), Class II - Special Controls.

Submitted by Small Bone Innovations, Inc. (New York, US). The FDA issued a Cleared decision on March 30, 2006 after a review of 83 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. 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 - K060038

510(k) Number K060038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2006
Decision Date March 30, 2006
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K060038.
LATITUDE ELBOW PROTHESIS
K070787 · Tornier · Aug 2007
SBI LATERAL RADIO CAPITELLUM
K070236 · Small Bone Innovations, Inc. · Feb 2007
RHS
K060438 · Tornier · Apr 2006
TORNIER ELBOW PROSTHESIS
K050848 · Tornier · Jul 2005
MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS
K031218 · Tornier · May 2003
TORNIER TOTAL ELBOW PROSTHESIS
K011567 · Tornier · Jun 2001