Cleared Traditional

K893821 - ACETABULAR SHELLS & LINERS FOR ATH TOTA...

K893821 is the FDA 510(k) clearance for ACETABULAR SHELLS & LINERS FOR ATH TOTA... by Kinamed, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K893821 · Kinamed, Inc. · Orthopedic device
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Nov 1989
Decision
167d
Days
Class 2
Risk

K893821 is an FDA 510(k) clearance for the ACETABULAR SHELLS & LINERS FOR ATH TOTAL HIP SYST.. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Kinamed, Inc. (Los Angeles, US). The FDA issued a Cleared decision on November 6, 1989 after a review of 167 days - an extended review 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: 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 Kinamed, Inc. devices

Submission Details

510(k) Number K893821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1989
Decision Date November 06, 1989
Days to Decision 167 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
45d slower than avg
Panel avg: 122d · This submission: 167d
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 K893821.
QUANTUM HIP STEM
K896325 · Depuy, Inc. · Jan 1990
DIMENSION REVISION TOTAL HIP SYSTEM
K895636 · Kirschner Medical Corp. · Dec 1989
LORD L.F.R. TOTAL HIP SYSTEM
K884890 · Howmedica Corp. · Dec 1989
FREEMAN MODULAR HIP STEM RIDGED VERSION
K890498 · Orthopedic Systems, Inc. · Oct 1989
MODIFIED GEMINI ACETABULAR CUP
K894298 · Depuy, Inc. · Sep 1989
MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL
K894149 · Howmedica Corp. · Sep 1989