Cleared Special

K090076 - SALTO TALARIS TOTAL ANKLE PROSTHESIS

K090076 is an FDA 510(k) clearance for SALTO TALARIS TOTAL ANKLE PROSTHESIS, manufactured by Tornier. The device is a Class 2 Orthopedic device with product code HSN cleared through the Special 510(k) pathway after a 64-day FDA review.

K090076 · Tornier · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
64d
Days
Class 2
Risk

K090076 is an FDA 510(k) clearance for the SALTO TALARIS TOTAL ANKLE PROSTHESIS. Classified as Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (product code HSN), Class II - Special Controls.

Submitted by Tornier (Saint-Ismier Cedex, FR). The FDA issued a Cleared decision on March 17, 2009 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3110 - 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 - K090076

510(k) Number K090076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2009
Decision Date March 17, 2009
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

HSN Device Classification - Class 2, Special Controls

Product Code HSN Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3110
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 - HSN Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer

All 68
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K090076.
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Download PDF FDA Summary Tornier