Cleared Traditional

CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER (K891082) - FDA 510(k) Clearance

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

K891082 · Depuy, Inc. · Orthopedic device
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Jun 1989
Decision
100d
Days
Class 2
Risk

K891082 is an FDA 510(k) clearance for the CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 9, 1989 after a review of 100 days - within the typical 510(k) review window.

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 Depuy, Inc. devices

Submission Details

510(k) Number K891082 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 01, 1989
Decision Date June 09, 1989
Days to Decision 100 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 122d · This submission: 100d
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 290
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K891082.
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, SMALL TAPER
K891083 · Depuy, Inc. · Jun 1989
CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER
K890060 · Depuy, Inc. · Mar 1989
THREADED TITANIUM METAL BACKED ACETABULAR CUP
K861400 · Depuy, Inc. · Jun 1986