Cleared Traditional

K050848 - TORNIER ELBOW PROSTHESIS

K050848 is an FDA 510(k) clearance for TORNIER ELBOW PROSTHESIS, manufactured by Tornier. The device is a Class 2 Orthopedic device with product code JDB cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K050848 · Tornier · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
101d
Days
Class 2
Risk

K050848 is an FDA 510(k) clearance for the TORNIER ELBOW PROSTHESIS. Classified as Prosthesis, Elbow, Semi-constrained, Cemented (product code JDB), Class II - Special Controls.

Submitted by Tornier (Monbonnot Saint Martin, FR). The FDA issued a Cleared decision on July 14, 2005 after a review of 101 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 Tornier devices

FDA 510(k) Submission Details - K050848

510(k) Number K050848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2005
Decision Date July 14, 2005
Days to Decision 101 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
21d faster than avg
Panel avg: 122d · This submission: 101d
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 K050848.
SBI LATERAL RADIO CAPITELLUM
K070236 · Small Bone Innovations, Inc. · Feb 2007
RHS
K060438 · Tornier · Apr 2006
SBI RADIO-CAPITELLAR IMPLANT
K060038 · Small Bone Innovations, Inc. · Mar 2006
MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS
K031218 · Tornier · May 2003
TORNIER TOTAL ELBOW PROSTHESIS
K011567 · Tornier · Jun 2001
CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
K983141 · Johnson & Johnson Professionals, Inc. · Nov 1998