Cleared Traditional

K823419 - HC 1M METALBACKED ACETABULAR CUP

K823419 is the FDA 510(k) clearance for HC 1M METALBACKED ACETABULAR CUP by Osteonics Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

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 451

Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K823419.

SPECTRON PROTRUSIO CUP

K823725 · Richard'S Medical Equip., Inc. · Jan 1983

SPECTRON POLYETHYLENE ACCTUBULAR COMPON

K823728 · Richard'S Medical Equip., Inc. · Jan 1983

SPECTRON METAL BACK ACETABULAR COMPONENT

K823729 · Richard'S Medical Equip., Inc. · Jan 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

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K823419

Osteonics Corp.

Mchenry, IL · US

Regulatory profile

178 submissions 136 cleared

76% clearance rate · Active in Orthopedic

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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