510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K111472Substantially Equivalent

Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip System, Acetabular Shell, Helicon

Tgm Medical, Inc., El Dorado CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111472 is the FDA 510(k) clearance record for HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON, a class II device, cleared for Tgm Medical on under FDA product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented). FDA records list 6 510(k) clearances for Tgm Medical, from to . As of , FDA records show no recalls naming K111472.

Clearance record

Decision date
Received
(102 days to decision)
Product code
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation
21 CFR 888.3358
Device class
Class II
Review panel
Orthopedic
Applicant
Tgm Medical 5145 Golden Foothill Pkwy., El Dorado CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LPH

Trailing 12 months
11 clearances under product code LPH in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LPH, trailing twelve months
MonthClearances
November 20252
December 20251
January 20261
February 20261
March 20260
April 20260
May 20261
June 20261
July 20261
August 20262
September 20261
October 20260