Cleared Traditional

K932481 - SL-PLUS AND SLR-PLUS

K932481 is an FDA 510(k) clearance for SL-PLUS AND SLR-PLUS, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 380-day FDA review.

K932481 · Encore Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K932481

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
Combination Product No
PCCP Authorized No
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.

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 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K932481.
KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION
K935206 · Kirschner Medical Corp. · Jul 1994
CS-PLUS STEM
K936214 · Encore Orthopedics, Inc. · Jun 1994
EXETER ALL PLASTIC ACETABULAR COMPONENT
K936132 · Howmedica, Inc. · Jun 1994
S.O.S. PROXIMAL FEMUR
K933281 · Wrightmedicaltechnologyinc · Jun 1994
FOUNDATION POROUS ACETABULAR COMPONENT
K936043 · Encore Orthopedics, Inc. · Jun 1994
FOUNDATION ALL POLY CUP
K934169 · Encore Orthopedics, Inc. · May 1994