Cleared Traditional

K821893 - ZIMMER METAL BACKED ACETABULAR CUP

K821893 is an FDA 510(k) clearance for ZIMMER METAL BACKED ACETABULAR CUP, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K821893 · Zimmer, Inc. · Orthopedic device
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Sep 1982
Decision
78d
Days
Class 2
Risk

K821893 is an FDA 510(k) clearance for the ZIMMER METAL BACKED ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982 after a review of 78 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K821893

510(k) Number K821893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1982
Decision Date September 14, 1982
Days to Decision 78 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 122d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

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 465
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K821893.
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
HC 1M METALBACKED ACETABULAR CUP
K823419 · Osteonics Corp. · Jan 1983
POROCOAT LOW PROFILE METAL BACKED CUP
K821713 · Depuy, Inc. · Aug 1982
POROCOAT STANDARD METAL BACKED CUP
K821714 · Depuy, Inc. · Aug 1982
TITANIUM AUFRANC-TURNER ATS HIP SYS
K821369 · Howmedica Corp. · May 1982