Cleared Traditional

K953977 - PRIMALOC CEMENTLESS HIP SYSTEM

K953977 is an FDA 510(k) clearance for PRIMALOC CEMENTLESS HIP SYSTEM, manufactured by Ortho Development Corp.. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K953977 · Ortho Development Corp. · Orthopedic device
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Jan 1996
Decision
156d
Days
Class 2
Risk

K953977 is an FDA 510(k) clearance for the PRIMALOC CEMENTLESS HIP SYSTEM. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on January 26, 1996 after a review of 156 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - 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 Ortho Development Corp. devices

FDA 510(k) Submission Details - K953977

510(k) Number K953977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1995
Decision Date January 26, 1996
Days to Decision 156 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 122d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWY Device Classification - Class 2, Special Controls

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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 - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 76
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K953977.
PRIMALOC CEMENTED HIP SYSTEM
K962448 · Ortho Development Corp. · Sep 1996
BI-LOC BIPOLAR CUP
K961793 · Ortho Development Corp. · Jul 1996
P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT
K945518 · Johnson & Johnson Professionals, Inc. · Mar 1996
UHMWPE COMPONENTS-CHANGE IN PACKAGING
K940743 · Depuy, Inc. · Sep 1995
HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS
K953510 · Encore Orthopedics, Inc. · Aug 1995
P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR
K945793 · Johnson & Johnson Professionals, Inc. · Apr 1995