Cleared Traditional

K100886 - INBONE II TOTAL ANKLE REPLACEMENT

K100886 is an FDA 510(k) clearance for INBONE II TOTAL ANKLE REPLACEMENT, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HSN cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K100886 · Wrightmedicaltechnologyinc · Orthopedic device
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Aug 2010
Decision
149d
Days
Class 2
Risk

K100886 is an FDA 510(k) clearance for the INBONE II TOTAL ANKLE REPLACEMENT. Classified as Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (product code HSN), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on August 26, 2010 after a review of 149 days - within the typical 510(k) review window.

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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K100886

510(k) Number K100886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2010
Decision Date August 26, 2010
Days to Decision 149 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
27d slower than avg
Panel avg: 122d · This submission: 149d
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 65
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K100886.
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SALTO TALARIS TOTAL ANKLE PROSTHESIS
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