Cleared Traditional

K220731 - Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem

K220731 is an FDA 510(k) clearance for Insignia Hip Stem, manufactured by Stryker. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K220731 · Stryker · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2022
Decision
150d
Days
Class 2
Risk

K220731 is an FDA 510(k) clearance for the Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Stryker (Mahwah, US). The FDA issued a Cleared decision on August 11, 2022 after a review of 150 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Stryker devices

FDA 510(k) Submission Details - K220731

510(k) Number K220731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2022
Decision Date August 11, 2022
Days to Decision 150 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
28d slower than avg
Panel avg: 122d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEH Device Classification - Class 2, Special Controls

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 152
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K220731.
DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional
K231873 · Depuy Ireland UC · Jan 2024
ACTERA™ hip system
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SignaSure Dual Mobility System
K220495 · Signature Orthopaedics Pty, Ltd. · Jan 2023
Actera™ hip system
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SignaSure Dual Mobility System
K211742 · Signature Orthopaedics Pty, Ltd. · Jan 2022
Encore Hip Stem
K211505 · Signature Orthopaedics Pty, Ltd. · Sep 2021