Cleared Traditional

K072101 - RIGI-FIX HIP STEM SYSTEM

K072101 is an FDA 510(k) clearance for RIGI-FIX HIP STEM SYSTEM, manufactured by Implants Intl. , Ltd.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K072101 · Implants Intl. , Ltd. · Orthopedic device
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Nov 2007
Decision
111d
Days
Class 2
Risk

K072101 is an FDA 510(k) clearance for the RIGI-FIX HIP STEM SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Implants Intl. , Ltd. (Thornaby-On-Tees, GB). The FDA issued a Cleared decision on November 19, 2007 after a review of 111 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 Implants Intl. , Ltd. devices

FDA 510(k) Submission Details - K072101

510(k) Number K072101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2007
Decision Date November 19, 2007
Days to Decision 111 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 122d · This submission: 111d
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 494
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K072101.
REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED)
K072888 · Encore Medical, L.P. · Jan 2008
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K072963 · DePuy Orthopaedics, Inc. · Jan 2008
FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM
K072154 · Encore Medical, L.P. · Dec 2007
REFLECTION, TANDEM UNIPOLAR
K071160 · Smith & Nephew, Inc. · Oct 2007
DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS
K071784 · DePuy Orthopaedics, Inc. · Jul 2007
VITALITY HIP SYSTEM MODEL#420
K070050 · Encore Medical, L.P. · May 2007