Cleared Traditional

K941141 - PRECISION OSTELOCK SP FEMORAL COMPONENT

K941141 is the FDA 510(k) clearance for PRECISION OSTELOCK SP FEMORAL COMPONENT by Howmedica Corp.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K941141 · Howmedica Corp. · Orthopedic device
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Sep 1994
Decision
202d
Days
Class 2
Risk

K941141 is an FDA 510(k) clearance for the PRECISION OSTELOCK SP FEMORAL COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on September 28, 1994 after a review of 202 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 K941141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1994
Decision Date September 28, 1994
Days to Decision 202 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
80d slower than avg
Panel avg: 122d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 428
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K941141.
APOGEE HIP STEM WITH POROCOAT
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ORTHOMET ACETABULAR CUP SYSTEM
K931333 · Orthomet, Inc. · Oct 1994
OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM
K943054 · Osteonics Corp. · Oct 1994
INFINITY REVISION HIP STEM
K942115 · Wrightmedicaltechnologyinc · Sep 1994
OSTEONICS SCREWLESS ACETABULAR COMPONENTS
K935875 · Osteonics Corp. · Jul 1994
PROVIDENT HIP SYSTEM
K935484 · Stelkast Company · Jun 1994