Cleared Traditional

Biocore9 Acetabular Cup System (K212761) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 324
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 Z Cup Cortinium
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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