Cleared Traditional

K061749 - ECLIPSE TOTAL ANKLE IMPLANT

K061749 is an FDA 510(k) clearance for ECLIPSE TOTAL ANKLE IMPLANT, manufactured by Kinetikos Medical, Inc.. The device is a Class 2 Orthopedic device with product code HSN cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K061749 · Kinetikos Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
154d
Days
Class 2
Risk

K061749 is an FDA 510(k) clearance for the ECLIPSE TOTAL ANKLE IMPLANT. Classified as Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (product code HSN), Class II - Special Controls.

Submitted by Kinetikos Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 22, 2006 after a review of 154 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3110 - 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 Kinetikos Medical, Inc. devices

FDA 510(k) Submission Details - K061749

510(k) Number K061749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2006
Decision Date November 22, 2006
Days to Decision 154 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
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 61
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K061749.
INBONE TOTAL ANKLE SYSTEM MODEL 200347902
K103374 · Wrightmedicaltechnologyinc · Dec 2010
INBONE II TOTAL ANKLE REPLACEMENT
K100886 · Wrightmedicaltechnologyinc · Aug 2010
SALTO TALARIS TOTAL ANKLE PROSTHESIS
K090076 · Tornier · Mar 2009
SALTO TALARIS TOTAL ANKLE PROSTHESIS
K060544 · Tornier · Nov 2006
AGILITY LP TOTAL ANKLE PROSTHESIS
K053569 · DePuy Orthopaedics, Inc. · Mar 2006
AGILITY ANKLE REVISION PROSTHESIS
K020541 · Depuy, Inc. · May 2002