Cleared Traditional

K900628 - MODULAR HIP SYSTEM

K900628 is an FDA 510(k) clearance for MODULAR HIP SYSTEM, manufactured by Richards Medical Co., Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K900628 · Richards Medical Co., Inc. · Orthopedic device
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May 1990
Decision
90d
Days
Class 2
Risk

K900628 is an FDA 510(k) clearance for the MODULAR HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on May 9, 1990 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 - K900628

510(k) Number K900628 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 08, 1990
Decision Date May 09, 1990
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 451
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K900628.
OSTEONICS PS HEAD AND NECK HIP STEM SERIES
K902712 · Osteonics Corp. · Aug 1990
KINAMED CEMENTED ATH-LONG STEM
K902073 · Kinamed, Inc. · Jun 1990
KINAMED CEMENTED CTH STEM
K902074 · Kinamed, Inc. · Jun 1990
KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL
K894904 · Kinamed, Inc. · Mar 1990
KIM MODULAR FEMORAL HIP PROSTHESIS
K895399 · Dow Corning Wright · Dec 1989
ZIRCONIA CERAMIC HEAD ADD'L SIZES
K896204 · Richards Medical Co., Inc. · Nov 1989