Cleared Traditional

K243768 - iTotal Identity Cruciate Retaining 3DP ...

K243768 is an FDA 510(k) clearance for iTotal Identity Cruciate Retaining 3DP ..., manufactured by Restor3D, Inc.. The device is a Class 2 Orthopedic device with product code MBH cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K243768 · Restor3D, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2025
Decision
111d
Days
Class 2
Risk

K243768 is an FDA 510(k) clearance for the iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Restor3D, Inc. (Durham, US). The FDA issued a Cleared decision on March 27, 2025 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - 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 Restor3D, Inc. devices

FDA 510(k) Submission Details - K243768

510(k) Number K243768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2024
Decision Date March 27, 2025
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBH Device Classification - Class 2, Special Controls

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
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 - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 130
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K243768.
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K241597 · Maxx Orthopedics, Inc. · Feb 2025
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K243615 · Lima Corporate S.P.A. · Dec 2024