Cleared Traditional

K890649 - OMNIFIT UHMWPE ACETABULAR SHELL CEMENT ...

K890649 is the FDA 510(k) clearance for OMNIFIT UHMWPE ACETABULAR SHELL CEMENT ... by Osteonics Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K890649 · Osteonics Corp. · Orthopedic device
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Mar 1989
Decision
33d
Days
Class 2
Risk

K890649 is an FDA 510(k) clearance for the OMNIFIT UHMWPE ACETABULAR SHELL CEMENT SPACE SYST.. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on March 13, 1989 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osteonics Corp. devices

Submission Details

510(k) Number K890649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1989
Decision Date March 13, 1989
Days to Decision 33 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
89d faster than avg
Panel avg: 122d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K890649.
INTRAFORM TOTAL HIP SYSTEM
K890742 · Orthomet, Inc. · May 1989
PERFECTA II/NON-COATED TOTAL HIP SYSTEM
K884027 · Orthomet, Inc. · Apr 1989
AML BOWED FEMORAL HIP
K885338 · Depuy, Inc. · Mar 1989
PERFECTA II TOTAL HIP SYSTEM
K883618 · Orthomet, Inc. · Dec 1988
PROFORMA HIP SYSTEM
K883941 · Orthomet, Inc. · Nov 1988
MODULAR COLLARED HJD TOTAL HIP SYSTEM
K884457 · Richards Medical Co., Inc. · Nov 1988