Cleared Traditional

K951356 - VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED

K951356 is an FDA 510(k) clearance for VARIOUS UHMWP HIP & KNEE JOINT PROSTHES..., manufactured by Biologically Oriented Prostheses. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K951356 · Biologically Oriented Prostheses · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
87d
Days
Class 2
Risk

K951356 is an FDA 510(k) clearance for the VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Biologically Oriented Prostheses (Port Huron, US). The FDA issued a Cleared decision on June 19, 1995 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biologically Oriented Prostheses devices

FDA 510(k) Submission Details - K951356

510(k) Number K951356 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 24, 1995
Decision Date June 19, 1995
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 122d · This submission: 87d
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 K951356.
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
SYSTEM 12 P1 26MM ACETABULAR INSERT
K951114 · Howmedica Corp. · Jun 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