Cleared Traditional

K885102 - OMNIFIT CERAMIC MORSE TAPER HEAD (1002 ...

K885102 is the FDA 510(k) clearance for OMNIFIT CERAMIC MORSE TAPER HEAD (1002 ... by Osteonics Corp.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K885102 · Osteonics Corp. · Orthopedic device
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Jun 1989
Decision
192d
Days
Class 2
Risk

K885102 is an FDA 510(k) clearance for the OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES). Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on June 22, 1989 after a review of 192 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 Osteonics Corp. devices

Submission Details

510(k) Number K885102 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 12, 1988
Decision Date June 22, 1989
Days to Decision 192 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
70d slower than avg
Panel avg: 122d · This submission: 192d
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 435
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K885102.
CERAMIC FEMORAL HEAD
K893685 · Dow Corning Wright · Sep 1989
ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
K885069 · Richards Medical Co., Inc. · Sep 1989
ATH CERAMIC UHMWPE TOTAL HIP SYSTEM
K890472 · Kinamed, Inc. · Sep 1989
CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER
K891082 · Depuy, Inc. · 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