Cleared Traditional

K864857 - OPTI-FIX ACETABULAR COMPONENT

K864857 is an FDA 510(k) clearance for OPTI-FIX ACETABULAR COMPONENT, manufactured by Richards Medical Co., Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K864857 · Richards Medical Co., Inc. · Orthopedic device
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Mar 1987
Decision
103d
Days
Class 2
Risk

K864857 is an FDA 510(k) clearance for the OPTI-FIX ACETABULAR COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on March 24, 1987 after a review of 103 days - within the typical 510(k) review window.

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 Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K864857

510(k) Number K864857 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 11, 1986
Decision Date March 24, 1987
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
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 465
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K864857.
HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE)
K870128 · Richards Medical Co., Inc. · May 1987
STANDARD POROCOAT MODIFIED MEDIAL ASPECT AML HIP
K870699 · Depuy, Inc. · May 1987
SDI TOTAL HIP SYSTEM
K871299 · Orthomet, Inc. · Apr 1987
MICROSTRUCTURED SPHERICAL ACETABULAR COMPONENTS
K870216 · Osteonics Corp. · Mar 1987
THREADED ACETABULAR COMPONENT
K870445 · Johnson & Johnson Professionals, Inc. · Mar 1987
MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY
K861988 · Protek, Inc. · Feb 1987