Cleared Traditional

K951114 - SYSTEM 12 P1 26MM ACETABULAR INSERT

K951114 is an FDA 510(k) clearance for SYSTEM 12 P1 26MM ACETABULAR INSERT, 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 98-day FDA review.

K951114 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
98d
Days
Class 2
Risk

K951114 is an FDA 510(k) clearance for the SYSTEM 12 P1 26MM ACETABULAR INSERT. 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 June 16, 1995 after a review of 98 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 - K951114

510(k) Number K951114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1995
Decision Date June 16, 1995
Days to Decision 98 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 122d · This submission: 98d
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 K951114.
OSTEONICS PS HEMI-HIP STEM SERIES
K933882 · Osteonics Corp. · Aug 1995
VITALOCK SOLID BACKED ACETABULAR SHELL
K952397 · Howmedica Corp. · Jul 1995
F-230 POROUS FEMORAL HIP STEM (CEMENTLESS)
K941612 · Implex Corp. · Jul 1995
HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS
K951115 · Howmedica Corp. · Jun 1995
ORTHOMET HMC FEMORAL STEM COMPONENT
K936310 · Orthomet, Inc. · Jun 1995
OSTEONICS OMNIFIT AD HIP STEM SERIES
K940715 · Osteonics Corp. · Jun 1995