Cleared Traditional

K884890 - LORD L.F.R. TOTAL HIP SYSTEM

K884890 is the FDA 510(k) clearance for LORD L.F.R. TOTAL HIP SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 381-day FDA review.

K884890 · Howmedica Corp. · Orthopedic device
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Dec 1989
Decision
381d
Days
Class 2
Risk

K884890 is an FDA 510(k) clearance for the LORD L.F.R. TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on December 8, 1989 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Howmedica Corp. devices

Submission Details

510(k) Number K884890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1988
Decision Date December 08, 1989
Days to Decision 381 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
259d slower than avg
Panel avg: 122d · This submission: 381d
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 435
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K884890.
TITANIUM MODULAR MODULAR COLLARLESS HIP
K895036 · Depuy, Inc. · Jan 1990
QUANTUM HIP STEM
K896325 · Depuy, Inc. · Jan 1990
DIMENSION REVISION TOTAL HIP SYSTEM
K895636 · Kirschner Medical 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