Cleared Traditional

MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP. (K884889) - FDA 510(k) Clearance

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

K884889 · Protek, Inc. · Orthopedic device
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Feb 1989
Decision
97d
Days
Class 2
Risk

K884889 is an FDA 510(k) clearance for the MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 27, 1989 after a review of 97 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 Protek, Inc. devices

Submission Details

510(k) Number K884889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1988
Decision Date February 27, 1989
Days to Decision 97 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 52
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K884889.
PROFILE COLLARED HIP PROSTHESIS
K904119 · Depuy, Inc. · Oct 1990
PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA
K896853 · Howmedica Corp. · May 1990
AML(R) COLLARLESS LATERALIZED FEMORAL HIP
K891482 · Depuy, Inc. · May 1989
HIP FRACTURE STEM SYSTEM
K883179 · Howmedica Corp. · Sep 1988
PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT
K872776 · Depuy, Inc. · Aug 1987
POROCOAT (R) PROXIMAL FEMORAL THIRD PROSTHESIS
K872025 · Depuy, Inc. · Aug 1987