Cleared Traditional

K896853 - PRECISION OSTEOLOCK FEMORAL COMP. TITAN...

K896853 is the FDA 510(k) clearance for PRECISION OSTEOLOCK FEMORAL COMP. TITAN... by Howmedica Corp.. It is a Class 2 Orthopedic device (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

Submission Details

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.

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 73
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K896853.
PROFILE COLLARED HIP PROSTHESIS
K904119 · Depuy, Inc. · Oct 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