Cleared Traditional

KDR ACETABULAR COMPONENT (K895702) - FDA 510(k) Clearance

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

K895702 · Osteonics Corp. · Orthopedic device
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Nov 1989
Decision
42d
Days
Class 2
Risk

K895702 is an FDA 510(k) clearance for the KDR ACETABULAR COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on November 3, 1989 after a review of 42 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 Osteonics Corp. devices

Submission Details

510(k) Number K895702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1989
Decision Date November 03, 1989
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 24
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K895702.
THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH
K905254 · Depuy, Inc. · Feb 1991
ACSYS SELFTAP ACETABULAR CUP PROSTHESIS
K900262 · 3M Company · Sep 1990
ACSYS SHEARER ACETABULAR CUP PROSTHESIS
K900435 · 3M Company · Sep 1990
KDG ACETABULAR COMPONENT
K891262 · Osteonics Corp. · Jun 1989
MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS)
K883661 · Depuy, Inc. · Feb 1989
OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING
K883921 · Osteonics Corp. · Oct 1988