Cleared Traditional

K151264 - Restoration Anatomic Shell

K151264 is an FDA 510(k) clearance for Restoration Anatomic Shell, manufactured by Stryker Orthopaedics. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K151264 · Stryker Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
89d
Days
Class 2
Risk

K151264 is an FDA 510(k) clearance for the Restoration Anatomic Shell. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on August 10, 2015 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Orthopaedics devices

FDA 510(k) Submission Details - K151264

510(k) Number K151264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2015
Decision Date August 10, 2015
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 453
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K151264.
Exactech® Novation® Crown Cup®
K141960 · Exactech, Inc. · Sep 2015
U2 Hip Stem, Ti Porous Coated, Matrix
K151316 · United Orthopedic Corporation · Aug 2015
Continuum and Trilogy Integrated Taper (IT) Acetabular Systems
K151448 · Zimmer, Inc. · Aug 2015
Modified Bencox Hip System
K150007 · Corentec Co., Ltd. · May 2015
G7 Dual Mobility System
K150522 · Biomet, Inc. · May 2015
Echo Bi-Metric Microplasty Line Extension
K150503 · Biomet, Inc. · Mar 2015