Cleared Traditional

K131022 - OVATION 10/12 HIP STEM

K131022 is the FDA 510(k) clearance for OVATION 10/12 HIP STEM by Ortho Development Corp.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K131022 · Ortho Development Corp. · Orthopedic device
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Oct 2013
Decision
187d
Days
Class 2
Risk

K131022 is an FDA 510(k) clearance for the OVATION 10/12 HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on October 16, 2013 after a review of 187 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 Ortho Development Corp. devices

Submission Details

510(k) Number K131022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2013
Decision Date October 16, 2013
Days to Decision 187 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
65d slower than avg
Panel avg: 122d · This submission: 187d
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 424
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K131022.
OVATION TRIBUTE HIP STEM
K133386 · Ortho Development Corp. · Mar 2014
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K132959 · DePuy Orthopaedics, Inc. · Mar 2014
MPACT EXTENSION
K132879 · Medacta International · Jan 2014
UTF STEM-REDUCED, ADDITIONAL SIZES
K132207 · United Orthopedic Corporation · Aug 2013
TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019
K130099 · Encore Medical, L.P. · Jun 2013
U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
K130149 · United Orthopedic Corporation · Jun 2013