Cleared Traditional

K133370 - REMEDY HIP STEM

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
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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.

View all Signature Orthopaedics Pty Limited devices

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
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 478
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K133370.
G7 OSSEOTI ACETUBLAR SHELLS
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Restoration Anatomic Shell
K142462 · Stryker Orthopaedics · Nov 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
KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS
K133832 · Total Joint Orthopedics, Inc. · Mar 2014