Cleared Traditional

HC 1M METALBACKED ACETABULAR CUP (K823419) - FDA 510(k) Clearance

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

K823419 · Osteonics Corp. · Orthopedic device
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Jan 1983
Decision
63d
Days
Class 2
Risk

K823419 is an FDA 510(k) clearance for the HC 1M METALBACKED ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Osteonics Corp. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1983 after a review of 63 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 K823419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1982
Decision Date January 17, 1983
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K823419.
HARRIS A.R. C. ACETABULAR CUP
K830857 · Howmedica Corp. · May 1983
POROCOAT DUAL-LOCK TOTAL HIP SYSTEM
K830004 · Depuy, Inc. · Apr 1983
TITANIUM M.E. MULLER TYPE TOTAL HIP
K830356 · Boehringer Mannheim Corp. · Mar 1983
ZIMMER METAL BACKED ACETABULAR CUP
K821893 · Zimmer, Inc. · Sep 1982
POROCOAT LOW PROFILE METAL BACKED CUP
K821713 · Depuy, Inc. · Aug 1982
POROCOAT STANDARD METAL BACKED CUP
K821714 · Depuy, Inc. · Aug 1982