Cleared Traditional

K133370 - REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE

K133370 is an FDA 510(k) clearance for REMEDY HIP STEM, manufactured by Signature Orthopaedics Pty Limited. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K133370 · Signature Orthopaedics Pty Limited · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
260d
Days
Class 2
Risk

K133370 is an FDA 510(k) clearance for the REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP.... Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Signature Orthopaedics Pty Limited (Nsw, AU). The FDA issued a Cleared decision on July 22, 2014 after a review of 260 days - an extended review 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: 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.

FDA 510(k) Submission Details - K133370

510(k) Number K133370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2013
Decision Date July 22, 2014
Days to Decision 260 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
138d slower than avg
Panel avg: 122d · This submission: 260d
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 560
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K133370.
RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM
K141676 · Renovis Surgical Technologies, Inc. · Nov 2014
ALPINE HIP STEM
K141001 · Ortho Development · Jul 2014
ALTEON 6.5MM BONE SCREWS
K141797 · Exactech, Inc. · Jul 2014
DELTA TT ACETABULAR SYSTEM
K141395 · Lima Corporate S.P.A. · Jun 2014
ENCOMPASS 10/12 HIP STEM
K132697 · Ortho Development Corp. · Jun 2014
CS2 MULTI-HOLE ACETABULAR SHELL
K141043 · Consensus Orthopedics, Inc. · May 2014