Cleared Traditional

K102180 - RHEAD RADIAL HEAD EXTENDED STEMS

K102180 is an FDA 510(k) clearance for RHEAD RADIAL HEAD EXTENDED STEMS, 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 140-day FDA review.

K102180 · Small Bone Innovations, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
140d
Days
Class 2
Risk

K102180 is an FDA 510(k) clearance for the RHEAD RADIAL HEAD EXTENDED STEMS. Classified as Prosthesis, Elbow, Semi-constrained, Cemented (product code JDB), Class II - Special Controls.

Submitted by Small Bone Innovations, Inc. (Morrisville, US). The FDA issued a Cleared decision on December 20, 2010 after a review of 140 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Small Bone Innovations, Inc. devices

FDA 510(k) Submission Details - K102180

510(k) Number K102180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2010
Decision Date December 20, 2010
Days to Decision 140 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
18d slower than avg
Panel avg: 122d · This submission: 140d
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 K102180.
LATITUDE EV™ Total Elbow Arthroplasty
K193247 · Tornier, Inc. · Aug 2020
LATITUDE EV Total Elbow Arthroplasty
K182461 · Tornier, Inc. · Dec 2018
Latitude EV Total Elbow Arthroplasty
K171010 · Tornier, Inc. · Aug 2017
LATITUDE ELBOW PROSTHESIS
K100562 · Tornier, Inc. · Jun 2010
LATITUDE ELBOW PROTHESIS
K070787 · Tornier · Aug 2007
SBI LATERAL RADIO CAPITELLUM
K070236 · Small Bone Innovations, Inc. · Feb 2007