Cleared Traditional

K230850 - United Orthopedic Knee Patient Specific Instrumentation (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230850 · Enhatch, Inc. · Orthopedic device
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Dec 2023
Decision
267d
Days
Class 2
Risk

K230850 is an FDA 510(k) clearance for the United Orthopedic Knee Patient Specific Instrumentation. Classified as Knee Arthroplasty Implantation System (product code OOG), Class II - Special Controls.

Submitted by Enhatch, Inc. (Hasbrouck Heights, US). The FDA issued a Cleared decision on December 20, 2023 after a review of 267 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 Enhatch, Inc. devices

Submission Details

510(k) Number K230850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2023
Decision Date December 20, 2023
Days to Decision 267 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
145d slower than avg
Panel avg: 122d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OOG Knee Arthroplasty Implantation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
Definition Intended To Be Used To Assist In The Implantation Of A Specific Knee Arthroplasty Device Or A Set Of Specific Knee Arthroplasty Devices. Indicated To Include Guiding Alignment, Making Or Establishing Cuts, Selecting, Sizing, Attaching, Positioning Or Orienting Implant Components.
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.