Cleared Traditional

K121297 - ORIGIN HIP STEM

K121297 is the FDA 510(k) clearance for ORIGIN HIP STEM by Signature Orthopaedics Pty, Ltd.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K121297 · Signature Orthopaedics Pty, Ltd. · Orthopedic device
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Dec 2012
Decision
242d
Days
Class 2
Risk

K121297 is an FDA 510(k) clearance for the ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-.... Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Signature Orthopaedics Pty, Ltd. (Chatswood, AT). The FDA issued a Cleared decision on December 28, 2012 after a review of 242 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, Ltd. devices

Submission Details

510(k) Number K121297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2012
Decision Date December 28, 2012
Days to Decision 242 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
120d slower than avg
Panel avg: 122d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 436
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K121297.
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K112898 · Lima Corporate S.P.A. · Dec 2012
REVELATION POROUS COATED HIP STEM, SIZE 8
K122636 · Encore Medical, L.P. · Nov 2012
SMITH & NEPHEW SMF HIP STEM
K123012 · Smith & Nephew, Inc. · Oct 2012