Cleared Traditional

K212761 - Biocore9 Acetabular Cup System

K212761 is an FDA 510(k) clearance for Biocore9 Acetabular Cup System, manufactured by Biocore9, LLC. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K212761 · Biocore9, LLC · Orthopedic device
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May 2022
Decision
259d
Days
Class 2
Risk

K212761 is an FDA 510(k) clearance for the Biocore9 Acetabular Cup System. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Biocore9, LLC (Whippany, US). The FDA issued a Cleared decision on May 17, 2022 after a review of 259 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 Biocore9, LLC devices

FDA 510(k) Submission Details - K212761

510(k) Number K212761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2021
Decision Date May 17, 2022
Days to Decision 259 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
137d slower than avg
Panel avg: 122d · This submission: 259d
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 K212761.
DePuy 3D Additive TriFlange Acetabular Cup
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BENCOX Mirabo Cup System
K220468 · Corentec Co., Ltd. · May 2022
Acetabular Dome Hole Plug
K220376 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Mar 2022
Restoration® Modular Hip System
K212187 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Mar 2022
R3 Large Head Liners
K211330 · Smith & Nephew, Inc. · Jan 2022