Cleared Traditional

K973124 - APR POROUS HA HIP SYSTEM

K973124 is an FDA 510(k) clearance for APR POROUS HA HIP SYSTEM, manufactured by Sulzer Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K973124 · Sulzer Orthopedics, Inc. · Orthopedic device
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Nov 1997
Decision
75d
Days
Class 2
Risk

K973124 is an FDA 510(k) clearance for the APR POROUS HA HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Sulzer Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on November 3, 1997 after a review of 75 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 Sulzer Orthopedics, Inc. devices

FDA 510(k) Submission Details - K973124

510(k) Number K973124 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 20, 1997
Decision Date November 03, 1997
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
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 453
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K973124.
FOUNDATION POROUS HIP STEM
K973302 · Encore Orthopedics, Inc. · Dec 1997
ACETABULAR SHELLS WITH MESH INGROWTH SURFACE
K973163 · Howmedica Corp. · Nov 1997
DEPUY DURALOC ACETABULAR CUP SYSTEM
K972596 · Depuy, Inc. · Nov 1997
INFINTY DISTAL FEMORAL COMPONENT
K973530 · Wrightmedicaltechnologyinc · Oct 1997
INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)
K972393 · Sulzer Orthopedics, Inc. · Sep 1997
DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
K970241 · Depuy, Inc. · Aug 1997