Cleared Traditional

K891083 - CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER

K891083 is an FDA 510(k) clearance for CERAMIC TOTAL HIP BALL HEAD, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K891083 · Depuy, Inc. · Orthopedic device
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Jun 1989
Decision
100d
Days
Class 2
Risk

K891083 is an FDA 510(k) clearance for the CERAMIC TOTAL HIP BALL HEAD, SMALL 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

FDA 510(k) Submission Details - K891083

510(k) Number K891083 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.

LZO Device Classification - Class 2, Special Controls

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 510
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K891083.
ATH CERAMIC UHMWPE TOTAL HIP SYSTEM
K890472 · Kinamed, Inc. · Sep 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
VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC
K884952 · Protek, Inc. · May 1989
CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER
K890060 · Depuy, Inc. · Mar 1989
THREADED TITANIUM METAL BACKED ACETABULAR CUP
K861400 · Depuy, Inc. · Jun 1986