Cleared Special

K011567 - TORNIER TOTAL ELBOW PROSTHESIS

K011567 is an FDA 510(k) clearance for TORNIER TOTAL ELBOW PROSTHESIS, manufactured by Tornier. The device is a Class 2 Orthopedic device with product code JDB cleared through the Special 510(k) pathway after a 29-day FDA review.

K011567 · Tornier · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
29d
Days
Class 2
Risk

K011567 is an FDA 510(k) clearance for the TORNIER TOTAL ELBOW PROSTHESIS. Classified as Prosthesis, Elbow, Semi-constrained, Cemented (product code JDB), Class II - Special Controls.

Submitted by Tornier (Montbonnot, FR). The FDA issued a Cleared decision on June 19, 2001 after a review of 29 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 - K011567

510(k) Number K011567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2001
Decision Date June 19, 2001
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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 26
Devices cleared under the same product code (JDB) and FDA review panel - the closest regulatory comparables to K011567.
SBI RADIO-CAPITELLAR IMPLANT
K060038 · Small Bone Innovations, Inc. · Mar 2006
TORNIER ELBOW PROSTHESIS
K050848 · Tornier · Jul 2005
MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS
K031218 · Tornier · May 2003
CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
K983141 · Johnson & Johnson Professionals, Inc. · Nov 1998
ABC TOTAL ELBOW PROTHESIS
K972691 · Biomet, Inc. · Oct 1997
SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)
K960087 · Wrightmedicaltechnologyinc · Sep 1996
K011567 · TORNIER TOTAL ELBOW PROSTHESIS
Download PDF FDA Summary Tornier