REPLICA TOTAL HIP SYSTEM— 510(k) K951741

Name: FDA 510(k) clearance K951741
Creator: U.S. Food and Drug Administration
Published: 1995-08-07

Substantially Equivalent for Some Indications

Osteo-Technology Intl., Inc.

FDA 510(k) clearance K951741 for REPLICA TOTAL HIP SYSTEM, Substantially Equivalent for Some Indications on 1995-08-07. Applicant: Osteo-Technology Intl., Inc.. Device class: 2.

Clearance details

Applicant: Osteo-Technology Intl., Inc.
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 1995-03-31
Decision date: 1995-08-07
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Hunt Valley, MD, US

Download summary PDF View on FDA.gov ↗

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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

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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.