Mg-PSZ Ceramic Femoral Head— 510(k) K220336

Name: FDA 510(k) clearance K220336
Creator: U.S. Food and Drug Administration
Published: 2022-09-30

Substantially Equivalent

Theken Companies

FDA 510(k) clearance K220336 for Mg-PSZ Ceramic Femoral Head, Substantially Equivalent on 2022-09-30. Applicant: Theken Companies. Device class: 2.

Clearance details

Applicant: Theken Companies
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2022-02-07
Decision date: 2022-09-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LPH

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K253630 — Mpact 3D Metal Foam2026-08-28
K254043 — TRIVANCE Hip Stem2026-08-04
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.