Cleared Traditional

OPTI-FIX TOTAL HIP SYSTEM (K860635) - FDA 510(k) Clearance

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

K860635 · Richards Medical Co., Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
22d
Days
Class 2
Risk

K860635 is an FDA 510(k) clearance for the OPTI-FIX TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on March 14, 1986 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Richards Medical Co., Inc. devices

Submission Details

510(k) Number K860635 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 20, 1986
Decision Date March 14, 1986
Days to Decision 22 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K860635.
TRI-LOCK II TITANIUM ACETABULUM PROSTHESIS
K862702 · Depuy, Inc. · Jul 1986
POROUS COATED HIP FEMORAL PROSTHESIS
K862326 · Johnson & Johnson Professionals, Inc. · Jul 1986
PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259
K860442 · Howmedica Corp. · May 1986
AML PROXIMAL POROCOAT FEMORAL HIP
K852198 · Depuy, Inc. · Aug 1985
POROCOAT HPS II HIP PROSTHESIS
K833681 · Depuy, Inc. · Mar 1984
POROCOAT NEB TOTAL HIP SYSTEM
K833439 · Depuy, Inc. · Mar 1984