Cleared Traditional

K191056 - Conformity stem

K191056 is the FDA 510(k) clearance for Conformity stem by United Orthopedic Corporation. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K191056 · United Orthopedic Corporation · Orthopedic device
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Jan 2020
Decision
259d
Days
Class 2
Risk

K191056 is an FDA 510(k) clearance for the Conformity stem, cemented. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by United Orthopedic Corporation (Hsinchu City, TW). The FDA issued a Cleared decision on January 3, 2020 after a review of 259 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 United Orthopedic Corporation devices

Submission Details

510(k) Number K191056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2019
Decision Date January 03, 2020
Days to Decision 259 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
137d slower than avg
Panel avg: 122d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 447
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K191056.
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K191414 · Stryker Orthopaedics · Aug 2019
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K181340 · Signature Orthopaedics Pty, Ltd. · Feb 2019
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K180973 · Maxx Orthopedics, Inc. · Sep 2018