Cleared Traditional

K844818 - NORMALIZED HS3N PROPORTIONAL SERIES HIP...

K844818 is the FDA 510(k) clearance for NORMALIZED HS3N PROPORTIONAL SERIES HIP... by Osteonics Corp.. It is a Class 2 Orthopedic device (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

Submission Details

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.

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 77
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K844818.
BROOKER BIO-GROOVE FEMORAL COMPONENT
K864085 · Biomet, Inc. · Jan 1987
BIO-FIT HIP SYSTEM
K854791 · Richards Medical Co., Inc. · Feb 1986
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