Cleared Traditional

LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLE (K896850) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K896850 · Lima Intl. Corp. · Orthopedic device
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Jun 1990
Decision
182d
Days
Class 2
Risk

K896850 is an FDA 510(k) clearance for the LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLE. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Lima Intl. Corp. (E Providence, US). The FDA issued a Cleared decision on June 5, 1990 after a review of 182 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Lima Intl. Corp. devices

Submission Details

510(k) Number K896850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1989
Decision Date June 05, 1990
Days to Decision 182 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 122d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 292
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K896850.
ZIRCONIA CERAMIC MODULAR HEADS
K905687 · Biomet, Inc. · Apr 1991
ZIMMER CERAMIC FEMORAL HEADS
K905739 · Zimmer, Inc. · Mar 1991
OSTEONICS PS HEAD AND NECK HIP STEM SERIES
K902712 · Osteonics Corp. · Aug 1990
OMNIFIT CERAMIC MORSE TAPER HEAD
K894694 · Osteonics Corp. · Oct 1989
OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES)
K885102 · Osteonics Corp. · Jun 1989
CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER
K891082 · Depuy, Inc. · Jun 1989