Cleared Traditional

K884889 - MODIFIED O.E.C. UNIV. SELF-ALIGNING ACE...

K884889 is an FDA 510(k) clearance for MODIFIED O.E.C. UNIV. SELF-ALIGNING ACE..., manufactured by Protek, Inc.. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K884889 · Protek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K884889

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
Combination Product No
PCCP Authorized No
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.

KWL Device Classification - Class 2, Special Controls

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 81
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K884889.
EVOLUTION HIP SYSTEM
K896105 · Dow Corning Wright · Dec 1989
BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM
K895886 · Biopro, Inc. · Dec 1989
AML(R) COLLARLESS LATERALIZED FEMORAL HIP
K891482 · Depuy, Inc. · May 1989
NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI
K884789 · Protek, Inc. · Feb 1989
HIP FRACTURE STEM SYSTEM
K883179 · Howmedica Corp. · Sep 1988
ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS
K874915 · Orthomet, Inc. · Feb 1988