KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP— 510(k) K020170

Name: FDA 510(k) clearance K020170
Creator: U.S. Food and Drug Administration
Published: 2002-02-11

Substantially Equivalent

Encore Orthopedics, Inc.

FDA 510(k) clearance K020170 for KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP, Substantially Equivalent on 2002-02-11. Applicant: Encore Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Encore Orthopedics, Inc.
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2002-01-17
Decision date: 2002-02-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, 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 Encore Orthopedics, Inc.

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K032905 — 3DKNEE POROUS COATED FEMORAL COMPONENT2004-07-06
K020114 — 3D KNEE2002-07-12
K020741 — UNICONDYLAR KNEE2002-06-04
K020236 — MODIFICATION TO PASS SPINAL SYSTEM2002-02-14
K013490 — CEMENTED CALCAR HIP SYSTEM2002-01-17

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.