Cleared Special

K070787 - LATITUDE ELBOW PROTHESIS

K070787 is an FDA 510(k) clearance for LATITUDE ELBOW PROTHESIS, manufactured by Tornier. The device is a Class 2 Orthopedic device with product code JDB cleared through the Special 510(k) pathway after a 155-day FDA review.

K070787 · Tornier · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
155d
Days
Class 2
Risk

K070787 is an FDA 510(k) clearance for the LATITUDE ELBOW PROTHESIS. Classified as Prosthesis, Elbow, Semi-constrained, Cemented (product code JDB), Class II - Special Controls.

Submitted by Tornier (Saint-Ismier Cedex, FR). The FDA issued a Cleared decision on August 24, 2007 after a review of 155 days - an extended review 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. Standard predicate reliance. 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 - K070787

510(k) Number K070787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2007
Decision Date August 24, 2007
Days to Decision 155 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
33d slower than avg
Panel avg: 122d · This submission: 155d
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 K070787.
Latitude EV Total Elbow Arthroplasty
K171010 · Tornier, Inc. · Aug 2017
RHEAD RADIAL HEAD EXTENDED STEMS
K102180 · Small Bone Innovations, Inc. · Dec 2010
LATITUDE ELBOW PROSTHESIS
K100562 · Tornier, Inc. · Jun 2010
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
K070787 · LATITUDE ELBOW PROTHESIS
Download PDF FDA Summary Tornier