iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating— 510(k) K243192

Name: FDA 510(k) clearance K243192
Creator: U.S. Food and Drug Administration
Published: 2026-06-05

Substantially Equivalent

Nextstep Arthopedix, LLC

FDA 510(k) clearance K243192 for iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating, Substantially Equivalent on 2026-06-05. Applicant: Nextstep Arthopedix, LLC. Device class: 2.

Clearance details

Applicant: Nextstep Arthopedix, LLC
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2024-09-30
Decision date: 2026-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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K261624 — Omnifit® 20° Series I Insert +11 more2026-07-10
K251270 — Taperloc® Complete Hip Stem2026-05-19
K252623 — G7® Revision Acetabular System2026-02-04

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.