Cleared Traditional

K860442 - PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259

K860442 is an FDA 510(k) clearance for PRECISION HIP SYSTEM PROXIMAL FEMORAL S..., manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K860442 · Howmedica Corp. · Orthopedic device
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May 1986
Decision
91d
Days
Class 2
Risk

K860442 is an FDA 510(k) clearance for the PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259. 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 May 6, 1986 after a review of 91 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K860442

510(k) Number K860442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1986
Decision Date May 06, 1986
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

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 534
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K860442.
ACCESS(TM), SOFTWARE RELEASE 4.11P
K896637 · Diasonics, Inc. · Jan 1990
TRI-LOCK II TITANIUM ACETABULUM PROSTHESIS
K862702 · Depuy, Inc. · Jul 1986
POROUS COATED HIP FEMORAL PROSTHESIS
K862326 · Johnson & Johnson Professionals, Inc. · Jul 1986
OPTI-FIX TOTAL HIP SYSTEM
K860635 · Richards Medical Co., Inc. · Mar 1986
AML PROXIMAL POROCOAT FEMORAL HIP
K852198 · Depuy, Inc. · Aug 1985
S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP
K851421 · Joint Medical Products Corp. · Jun 1985