Cleared Traditional

K873797 - TI-FIT TOTAL HIP SYSTEM

K873797 is an FDA 510(k) clearance for TI-FIT TOTAL HIP SYSTEM, manufactured by Richards Medical Co., Inc.. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K873797 · Richards Medical Co., Inc. · Orthopedic device
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Nov 1987
Decision
45d
Days
Class 2
Risk

K873797 is an FDA 510(k) clearance for the TI-FIT TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on November 2, 1987 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 - K873797

510(k) Number K873797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1987
Decision Date November 02, 1987
Days to Decision 45 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
77d faster than avg
Panel avg: 122d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LWJ Device Classification - Class 2, Special Controls

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 62
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K873797.
HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT
K881983 · Howmedica Corp. · Oct 1988
CORIN MODULAR MOORE STEM
K881288 · Orthopedic Systems, Inc. · Jun 1988
S-ROM SUPERCUP ACETABULAR CUP
K870088 · Joint Medical Products Corp. · Apr 1988
MICRO-STRUCTURED HS2P HIP STEMS
K833970 · Osteonics Corp. · Jan 1984