Cleared Special

Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length (K213580) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K213580 · Total Joint Othopedics, Inc. · Orthopedic device
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Dec 2021
Decision
23d
Days
Class 2
Risk

K213580 is an FDA 510(k) clearance for the Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Total Joint Othopedics, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 3, 2021 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Total Joint Othopedics, Inc. devices

Submission Details

510(k) Number K213580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2021
Decision Date December 03, 2021
Days to Decision 23 days
Submission Type Special
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
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 291
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K213580.
Corin MetaFix™ Hip Stem
K212069 · Corin U.S.A. Limited · Apr 2022
DePuy Corail AMT Hip Prosthesis
K213839 · DePuy Orthopaedics, Inc. · Jan 2022
Restoration Modular 115mm Conical Distal Stem
K213129 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Dec 2021
Mpres Neck Preserving Stem
K210263 · Medacta International S.A. · Sep 2021
EMPHASYS Femoral Stems
K211657 · Depuy Ireland UC · Aug 2021
Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads
K201657 · Corin, Ltd. · Jul 2021