Cleared Traditional

K891262 - KDG ACETABULAR COMPONENT

K891262 is an FDA 510(k) clearance for KDG ACETABULAR COMPONENT, manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K891262 · Osteonics Corp. · Orthopedic device
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Jun 1989
Decision
90d
Days
Class 2
Risk

K891262 is an FDA 510(k) clearance for the KDG 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 June 6, 1989 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 888.3360 - 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: 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 Osteonics Corp. devices

FDA 510(k) Submission Details - K891262

510(k) Number K891262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1989
Decision Date June 06, 1989
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.

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 73
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K891262.
ARC-2F ACETABULAR CUP
K893785 · Protek, Inc. · Aug 1989
GRIPPER II ACETABULAR CUP
K893584 · Joint Medical Products Corp. · Jul 1989
CTI II STRAIGHT STEM
K891539 · Orthopedic Systems, Inc. · Jun 1989
RESUBMITTED CLW ACETABULAR CUP W/SULMESH
K883794 · Protek, Inc. · May 1989
MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS)
K883661 · Depuy, Inc. · Feb 1989
OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING
K883921 · Osteonics Corp. · Oct 1988