Cleared Traditional

SL-PLUS AND SLR-PLUS (K932481) - FDA 510(k) Clearance

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

K932481 · Encore Orthopedics, Inc. · Orthopedic device
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Jun 1994
Decision
380d
Days
Class 2
Risk

K932481 is an FDA 510(k) clearance for the SL-PLUS AND SLR-PLUS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on June 8, 1994 after a review of 380 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 Encore Orthopedics, Inc. devices

Submission Details

510(k) Number K932481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1993
Decision Date June 08, 1994
Days to Decision 380 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
258d slower than avg
Panel avg: 122d · This submission: 380d
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 280
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K932481.
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PRECISION OSTEOLOCK ACETABULAR COMPONENT
K930275 · Howmedica Corp. · Sep 1994
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K933281 · Wrightmedicaltechnologyinc · Jun 1994
OSTEONICS OMNIFIT FORGED HIP STEM SERIES
K933561 · Osteonics Corp. · Mar 1994
OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS
K930187 · Osteonics Corp. · Mar 1994