Cleared Traditional

BOFOR REVISION COUP (K993874) - FDA 510(k) Clearance

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

K993874 · Plus Orthopedics · Orthopedic device
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Jun 2000
Decision
203d
Days
Class 2
Risk

K993874 is an FDA 510(k) clearance for the BOFOR REVISION COUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Plus Orthopedics (San Diego, US). The FDA issued a Cleared decision on June 5, 2000 after a review of 203 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Plus Orthopedics devices

Submission Details

510(k) Number K993874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1999
Decision Date June 05, 2000
Days to Decision 203 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 122d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 291
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K993874.
ACCOLADE C FEMORAL COMPONENT
K002320 · Howmedica Osteonics Corp. · Sep 2000
FENNING HIP STEM
K002441 · DePuy Orthopaedics, Inc. · Sep 2000
TRIDENT ACETABULAR SHELLS: PS
K001449 · Howmedica Osteonics Corp. · Aug 2000
RESPONSE 2000 HIP STEM
K000392 · DePuy Orthopaedics, Inc. · Apr 2000
RESPONSE 2000 CEMENTED HIP STEM
K000432 · DePuy Orthopaedics, Inc. · Apr 2000
PLR SPLINED REVISION STEM
K994184 · Biomet, Inc. · Feb 2000