Cleared Traditional

K896853 - PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA

K896853 is an FDA 510(k) clearance for PRECISION OSTEOLOCK FEMORAL COMP. TITAN..., manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K896853 · Howmedica Corp. · Orthopedic device
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May 1990
Decision
148d
Days
Class 2
Risk

K896853 is an FDA 510(k) clearance for the PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on May 2, 1990 after a review of 148 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K896853

510(k) Number K896853 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 05, 1989
Decision Date May 02, 1990
Days to Decision 148 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
26d slower than avg
Panel avg: 122d · This submission: 148d
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 91
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K896853.
KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD
K903885 · Kinamed, Inc. · Sep 1990
THOMPSON TYPE HIS PROSTHESIS
K903240 · Onyx Medical Corp. · Jul 1990
AUSTIN MOORE TYPE HIP PROSTHESIS
K903241 · Onyx Medical Corp. · Jul 1990
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