Cleared Traditional

K844818 - NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS

K844818 is an FDA 510(k) clearance for NORMALIZED HS3N PROPORTIONAL SERIES HIP..., manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K844818 · Osteonics Corp. · Orthopedic device
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Jul 1985
Decision
231d
Days
Class 2
Risk

K844818 is an FDA 510(k) clearance for the NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on July 30, 1985 after a review of 231 days - an extended review 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: 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 - K844818

510(k) Number K844818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1984
Decision Date July 30, 1985
Days to Decision 231 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
109d slower than avg
Panel avg: 122d · This submission: 231d
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 92
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K844818.
BIO-FIT HIP SYSTEM
K854791 · Richards Medical Co., Inc. · Feb 1986
MUELLER CURVED STEM HEMI-PROSTHESIS
K853662 · Protek, Inc. · Sep 1985
POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT
K852584 · Biomet, Inc. · Aug 1985
BTM TOTAL HIP SYSTEM
K852420 · Kirschner Medical Corp. · Jun 1985
TF-II HIP PROSTHESIS
K843995 · Dow Corning Corp. Healthcare Industries Materials · Apr 1985
AUSTIN-MOORE MODULAR HIP PROSTHESIS
K845025 · Biomet, Inc. · Apr 1985