HORIZON HIP SYSTEM— 510(k) K962769

Name: FDA 510(k) clearance K962769
Creator: U.S. Food and Drug Administration
Published: 1996-10-03

Substantially Equivalent

Biologically Oriented Prostheses

FDA 510(k) clearance K962769 for HORIZON HIP SYSTEM, Substantially Equivalent on 1996-10-03. Applicant: Biologically Oriented Prostheses. Device class: 2.

Clearance details

Applicant: Biologically Oriented Prostheses
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 1996-07-16
Decision date: 1996-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Huron, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LPH

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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

More clearances from Biologically Oriented Prostheses

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K002325 — WUJIN #3 TIBIAL NAIL2000-10-30
K992144 — BIOPRO RIMMED ACETABULAR COMPOMENT1999-09-22
K964472 — RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT1997-02-03
K955916 — TOWNLEY TOTAL ELBOW SYSTEM1996-08-08
K954768 — BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD1996-01-18

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.