510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K220731Substantially Equivalent

Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem

Stryker Corp., Mahwah NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220731 is the FDA 510(k) clearance record for Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem, a class II device, cleared for Stryker on under FDA product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate). FDA records list 568 510(k) clearances for Stryker, from to . As of , FDA records show no recalls naming K220731.

Clearance record

Decision date
Received
(150 days to decision)
Product code
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Regulation
21 CFR 888.3353
Device class
Class II
Review panel
Orthopedic
Applicant
Stryker 325 Corporate Dr., Mahwah NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MEH

Trailing 12 months
2 clearances under product code MEH in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MEH, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260