Cleared Traditional

K961899 - CPS, CEMENTED HIP SYSTEM

K961899 is an FDA 510(k) clearance for CPS, manufactured by Artos Medical Products GmbH. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K961899 · Artos Medical Products GmbH · Orthopedic device
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Aug 1996
Decision
77d
Days
Class 2
Risk

K961899 is an FDA 510(k) clearance for the CPS, CEMENTED HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Artos Medical Products GmbH (Indianapolis, US). The FDA issued a Cleared decision on August 1, 1996 after a review of 77 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 Artos Medical Products GmbH devices

FDA 510(k) Submission Details - K961899

510(k) Number K961899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1996
Decision Date August 01, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 122d · This submission: 77d
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 514
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K961899.
SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS
K960984 · Biomet, Inc. · Sep 1996
PERFECTA PS REVISION STEM
K962267 · Wrightmedicaltechnologyinc · Sep 1996
CPS, CEMENTED CUP SYSTEM
K962086 · Artos Medical Products GmbH · Aug 1996
COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT
K960278 · Zimmer, Inc. · Jul 1996
COLLARLESS POLISHED TAPER HIP PROSTHESIS
K960658 · Zimmer, Inc. · Jul 1996
NATURAL HIP SYSTEM - DRG HIP STEM
K961799 · Intermedics Orthopedics · Jul 1996