HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON— 510(k) K111472

Name: FDA 510(k) clearance K111472
Creator: U.S. Food and Drug Administration
Published: 2011-09-06

Substantially Equivalent

Tgm Medical

FDA 510(k) clearance K111472 for HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON, Substantially Equivalent on 2011-09-06. Applicant: Tgm Medical. Device class: 2.

Clearance details

Applicant: Tgm Medical
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2011-05-27
Decision date: 2011-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Dorado, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LPH

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K261624 — Omnifit® 20° Series I Insert +11 more2026-07-10
K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating2026-06-05
K251270 — Taperloc® Complete Hip Stem2026-05-19

Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.