Cleared Traditional

K881117 - RESUBMITTING OF HJD TOTAL HIP SYSTEM

K881117 is an FDA 510(k) clearance for RESUBMITTING OF HJD TOTAL HIP SYSTEM, 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 51-day FDA review.

K881117 · Richards Medical Co., Inc. · Orthopedic device
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Apr 1988
Decision
51d
Days
Class 2
Risk

K881117 is an FDA 510(k) clearance for the RESUBMITTING OF HJD TOTAL HIP SYSTEM. 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 April 29, 1988 after a review of 51 days - a notably fast clearance cycle.

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: 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

FDA 510(k) Submission Details - K881117

510(k) Number K881117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1988
Decision Date April 29, 1988
Days to Decision 51 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
71d faster than avg
Panel avg: 122d · This submission: 51d
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 K881117.
PROFORMA/PS TOTAL HIP SYSTEM
K880435 · Orthomet, Inc. · Jun 1988
HJD CALCAR REPLACEMENT PROSTHESIS
K881769 · Richards Medical Co., Inc. · Jun 1988
LCS FEMORAL HIP PROSTHESIS
K880269 · Depuy, Inc. · May 1988
INTRAFORM TOTAL HIP SYSTEM
K880390 · Orthomet, Inc. · Apr 1988
TITANIUM FEMORAL HIP
K881128 · Depuy, Inc. · Mar 1988
PERFECTA TOTAL HIP SYSTEM
K880461 · Orthomet, Inc. · Mar 1988