Cleared Traditional

K943778 - OSTEONICS RESTORATION CEMENTED HIP STEM SERIES

K943778 is an FDA 510(k) clearance for OSTEONICS RESTORATION CEMENTED HIP STEM..., 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 377-day FDA review.

K943778 · Osteonics Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 1995
Decision
377d
Days
Class 2
Risk

K943778 is an FDA 510(k) clearance for the OSTEONICS RESTORATION CEMENTED HIP STEM SERIES. 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 August 14, 1995 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K943778

510(k) Number K943778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1994
Decision Date August 14, 1995
Days to Decision 377 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
255d slower than avg
Panel avg: 122d · This submission: 377d
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 K943778.
JOHNSON & JOHNSON AUSTIN MOORE STEM
K955385 · Johnson & Johnson Professionals, Inc. · Jan 1996
OSTEONICS UNIPOLAR ENDO HEAD
K954534 · Osteonics Corp. · Nov 1995
UNITRAX V40 MODULAR ADAPTOR
K954077 · Howmedica Corp. · Nov 1995
ULTIMA AUGMENTED UHMWPE CUP
K950563 · Johnson & Johnson Professionals, Inc. · Jun 1995
LINK SADDLE PROTHESIS
K951355 · Turnkey Intergration USA, Inc. · May 1995
ULTIMA UNIPOLAR MODULAR HEAD
K940190 · Johnson & Johnson Orthopaedics, Inc. · Sep 1994